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Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024

Type Act

Publication 2024-02-28

State In force

Source Irish Statute Book

articles 110

Reform history JSON API

38. **Definitions (Part 3)**

38. In this Part—

“Act of 2004” means the Health Act 2004;

“Authority” means the Health Information and Quality Authority;

“child” includes a stillborn child;

“coronial post-mortem examination” means a post-mortem examination directed by or on behalf of a coroner under the Coroners Acts 1962 to 2024 in relation to a deceased person;

“designated healthcare worker” means—

(a) a registered medical practitioner,

(b) a registered nurse or registered midwife within the meaning of section 2(1) of the Nurses and Midwives Act 2011,

(c) a member of one or more of the following designated professions within the meaning of section 3 of the Health and Social Care Professionals Act 2005, namely:

(i) medical scientist;

(ii) psychologist;

(iii) social care worker;

(iv) social worker;

(v) such other designated profession within the meaning of the said section 3 of the said Act as the Minister considers appropriate and may prescribe by regulations under section 3,

(d) an anatomical pathology technician, or

(e) a staff member nominated for that purpose by the hospital concerned,

who by way of training and expertise has the relevant understanding and experience to undertake functions under this Part;

“health service” means the provision, by or under the direction of a health services provider, of clinical care or any ancillary service to a patient for—

(a) the screening (other than a cancer screening service), preservation or improvement of the health of the patient,

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

(c) the performance of 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 patient, or

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

“hospital” shall be construed in accordance with section 39;

“mother”, in relation to a foetus, means the woman who carried the foetus;

“nominated person” has the meaning assigned to it by section 52;

“non-coronial post-mortem examination” means the examination of the body of a deceased person (including a foetus or stillborn child) involving its dissection and the removal of part of a body which is carried out for a purpose specified in section 44 and includes—

(a) removal of tissue for diagnostic purposes and the retention of small samples of same as histological blocks and slides to form part of the post-mortem record, and

(b) for the purposes of a non-coronial post-mortem examination of a foetus, a laboratory examination performed on the foetus for any of the purposes specified in that section;

“part of a body” means any part of the human anatomy and includes but is not limited to—

(a) an organ,

(b) tissue,

(d) blood or any material derived from blood, or

(e) any other biological fluid;

“post-mortem examination report” has the meaning assigned to it by section 46;

“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 (within the meaning of the Health Act 2007),

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

(iii) a provider of a health service 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, or

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

“stillborn child” has the same meaning as it has in section 2(1) of the Civil Registration Act 2004.

39. Application of Part

39. (1) Subject to subsection (2), this Part shall apply to post-mortem activities and coronial post-mortem examinations that take place on or after the commencement of this section in a hospital (whether public or private) and a reference in this Part to a “hospital” includes a reference—

(a) to a private hospital, and

(b) to a facility (howsoever described) other than a hospital or relevant facility, within the meaning of section 2 of the Act of 1962, where post mortem activities are carried out in accordance with this Part by service providers (within the meaning of section 2 of the Health Act 2004), pursuant to section 38 of that Act.

(2) This Part shall not apply to—

(a) post-mortem activities which were commenced but not completed before the coming into operation of subsection (1), and

(b) subject to the operation as necessary of sections 33(2B), 33(2C), 33(2D), 33(3A), 33(3B), 33(3C), 33(3D), 33F, 33G, 33H, 33I, 33J, 33K, 33L, 33M, 33N and 33O of the Act of 1962, coronial post-mortem examinations.

40. Regulations for purposes of Part, including regulations to apply to certain aspects of coronial post-mortem examinations that take place in hospitals

40. (1) Subject to subsections (3) and (4), the Minister may make such regulations as he or she considers necessary or expedient for the management in the most respectful and appropriate manner possible of post-mortem activities and coronial post-mortem examinations that take place in a hospital.

(2) Without prejudice to the generality of subsection (1), regulations under subsection (1) may provide for all or any of the following matters:

(a) procedures for the retention, storage, disposal or return of material removed from the body as part of the coronial or non-coronial post-mortem examination, where such action is consistent with guidelines but shall not include tissue samples held on blocks or slides, trimmings or bodily fluids removed during the examination;

(b) the arrangements to be put in place by hospitals for—

(i) the management of authorisations (within the meaning of section 2 of the Act of 1962) under section 33F of that Act,

(ii) the designation of persons or classes or persons responsible for the management of such authorisations, and

(iii) the carrying out of the authorisations received from the coroner in that regard;

(d) prescribing the retention periods for records and samples arising from non coronial post-mortem activities, each of which periods (other than in the case of records and samples which are toxicology samples, trimmings or bodily fluids) shall not be less than 5 years;

(e) any other matters which are necessary or expedient for the purposes of giving effect to subsection (1).

(3) Before making regulations under subsection (1), the Minister shall consult such persons as he or she considers appropriate including all or any of the following:

(a) the Executive;

(b) the Authority;

(d) the Chief State Pathologist;

(e) a representative of the Coroners Society of Ireland;

(f) a pathologist from the Royal College of Physicians of Ireland, Faculty of Pathology;

(g) a relevant patient advocacy group.

(4) For the avoidance of doubt, nothing in section 39, this section or regulations made thereunder shall operate to prevent a coroner or any other person from complying with his or her obligations under the Coroners Acts 1962 to 2024.

41. (1) For the purposes of this Part—

(a) (i) post-mortem consent shall be in writing and shall be signed by the person giving the consent in the presence of one witness who shall attest the person’s signature, or

(ii) in a case where the person cannot provide consent in writing, post-mortem consent may be given orally by the person in the presence of two witnesses each of whom shall attest that the person gave consent,

(b) (i) subject to subparagraph (ii) post-mortem consent in relation to a post-mortem activity may, at any time, be withdrawn or amended in the manner specified in subparagraph (i) or (ii) of paragraph (a), and

(ii) post-mortem consent in relation to a non-coronial post-mortem examination or the recording of such examination may, at any time prior to the commencement of that post-mortem examination, be withdrawn or amended in the manner specified in subparagraph (i) or (ii) of paragraph (a),

(c) post-mortem consent given by a person is given, and given only, for the purposes of the post-mortem activities, specified in the consent concerned,

(d) where post-mortem consent is given by a person for the purposes of the post-mortem activities specified in the consent, it shall not be necessary to seek consent in respect of subsequent use provided that the use is only for the purposes specified in the consent concerned,

(e) a copy of a post-mortem consent, together with a copy of any withdrawal or amendment of the consent shall be—

(i) retained with the medical records of the deceased person or, in the case of a foetus, in accordance with the procedures of the hospital concerned and any guidelines made in that regard,

(ii) retained with the records of the hospital where the non-coronial post-mortem examination occurred for such period as shall be prescribed in regulations under section 40, and

(iii) made available to the person who gave the consent,

and

(f) post-mortem consent may be limited to—

(i) the non-coronial post-mortem examination and the burial, cremation or return, in accordance with regulations under section 40(2)(a), of any part of a body removed as part of that non-coronial post-mortem examination, other than any tissue removed and retained in accordance with section 43(3),

(ii) the non-coronial post-mortem examination and any other post-mortem activities specified in the consent,

(iii) a specific region of the body, or

(iv) particular tissues and organs.

(2) When seeking post-mortem consent for post-mortem activities to be carried out in accordance with section 47, 48, 49 or 50 a designated healthcare worker shall, in accordance with any guidelines, provide the following information to a relevant person:

(a) information sufficient to enable the relevant person to understand what the proposed post-mortem activities shall entail before post-mortem consent is provided;

(b) an indication of the parts of the body which are likely to be removed from the deceased adult, child or foetus;

(c) the types of information available to enable the relevant person to make an informed decision regarding the proposed post-mortem activities;

(d) confirmation of the relevant person’s entitlement to receive information on the proposed post-mortem activities either before or after he or she provides consent in relation to such activities;

(e) any information that it would be reasonable, on the request of the relevant person, for the designated healthcare worker to provide to the relevant person in relation to post-mortem activities before or after such activities take place;

(f) information on the options available to the relevant person in relation to the subsequent burial, cremation or return, in accordance with regulations under section 40(2)(a), of any part of a body retained following the post-mortem activities;

(g) an indication of the length of time a part of a body may, in accordance with regulations under section 40(2)(a), be retained and what the subsequent use, if any, of such part of a body may be;

(h) in the case of the proposed retention and use of any part of a body, including for the use by a third party, information relating to the types of use that this may entail;

(i) in the case of the proposed retention and use of any organ or tissue, including for the use for commercial purposes, information relating to types of commercial use that this may entail and the effect of section 50;

(j) confirmation that the post-mortem examination report shall be available to the relevant person at his or her request.

(3) In this section, “relevant person” means—

(a) in relation to a deceased adult in respect of whom it is proposed to carry out a non-coronial post-mortem examination—

(i) the adult, the subject of the examination where he or she has, prior to his or her death, consented to a non-coronial post-mortem examination being carried out on his or her body, or

(ii) the designated family member of the deceased adult where the deceased adult has not, prior to his or her death, consented to a non-coronial post-mortem examination being carried out on his or her body,

(b) in relation to a deceased child in respect of whom it is proposed to carry out a non-coronial post-mortem examination, a parent or guardian of the deceased child, or

(c) in relation to a foetus in respect of whom it is proposed to carry out a non-coronial post-mortem examination, the mother or a person acting on her behalf.

42. Post-mortem activities

42. (1) A person shall not carry out a post-mortem activity unless he or she is satisfied that post-mortem consent has been provided.

(2) For the purposes of this Part, “post-mortem activities” means all or any of the following:

(a) a non-coronial post-mortem examination;

(b) the retention, by the hospital where the non-coronial post-mortem examination took place, of any part of a body removed from the body of a deceased person or foetus during the examination, other than a retention referred to in the definition of “non-coronial post-mortem examination”;

(c) the use of any part of a body retained after a non-coronial post-mortem examination, including the use of any part of a body by a third party;

(d) the use of any organ or tissue retained after a non-coronial post-mortem examination, including the use of any part of a body for commercial purposes;

(e) the audio, visual or photographic recording of a non-coronial post-mortem examination;

(f) the burial, cremation or return, in accordance with regulations under section 40(2)(a), of any part of the body removed as part of a non-coronial post mortem examination, other than any tissue, trimmings or biological fluids removed as part of the examination.

(3) A person who contravenes subsection (1) shall be guilty of an offence.

43. Removal and retention of organs and other body parts during non-coronial post-mortem examination

43. (1) Where post-mortem consent is provided for a non-coronial post-mortem examination, any part of a body of a deceased adult, child or foetus on whose body the examination is performed may, by virtue of such consent, be removed from the body during the non-coronial post-mortem examination and used thereafter for the purposes of such examination.

(2) Where part of a body is removed in accordance with subsection (1), a tissue sample may be taken from that part and retained in accordance with subsection (3).

(3) A tissue sample removed for diagnostic purposes during a non-coronial post-mortem examination in accordance with subsection (2) and held on blocks or slides for this purpose shall be retained in the records of the hospital that carried out the examination for such period as shall be prescribed under section 40 and shall—

(a) in the case of a non-coronial post-mortem examination of an adult or child, form part of the medical records of the adult or child concerned, or

(b) in the case of a non-coronial post-mortem examination of a foetus, form part of the medical records specified for that purpose in accordance with the procedures of the hospital concerned and any guidelines made in that regard.

(4) A part of a body, other than a part of a body indicated in that behalf under section 41(2)(b) as likely to be removed, shall not be removed from a body during a non-coronial post-mortem examination.

(5) The removal of any part of a body during a non-coronial post-mortem examination, other than for the purpose of that examination, shall require post-mortem consent.

(6) A person or hospital shall not receive financial compensation or other non-financial inducements for any part of a body removed during a non-coronial post-mortem examination.

(7) Subject to section 50, any part of a body removed during a non-coronial post-mortem examination shall not be used for commercial purposes.

(8) A part of a body that was removed during the course of a non-coronial post mortem examination carried out before the date on which this section comes into operation, may be retained to be used for purposes associated with the non-coronial post-mortem examination without post-mortem consent but such part of a body shall not be sold or used for commercial purposes other than in accordance with the post-mortem consent.

44. Purposes for which post-mortem activities may be undertaken

44. A post-mortem activity may only be undertaken where the activity is carried out for one or more of the following purposes:

(a) determining or providing further information on the medical cause of death of the adult, child or foetus concerned;

(b) providing information to the designated family member or medical professional on the effectiveness of any medical or surgical intervention by a registered medical practitioner or the progression of a medical condition;

(c) obtaining scientific or medical information which may be of benefit to other persons and which information is important for assessing and improving the quality of medical care;

(d) medical research including research into the nature, causes and prevention of disease;

(e) undertaking non-coronial post-mortem examinations for purposes of education and training of healthcare professionals and medical and nursing students;

(f) undertaking non-coronial post-mortem examinations for purposes of clinical audit and quality assurance.

45. Carrying out of non-coronial post-mortem examination

45. (1) Without prejudice to the generality of section 42, a non-coronial post-mortem examination shall not be carried out by a person unless the person—

(a) is a pathologist or a registered medical practitioner under the supervision of a pathologist, and

(b) is satisfied the post-mortem consent, where appropriate, has been provided in accordance with section 47, 48, 49 or 50.

(2) A pathologist or a registered medical practitioner under the supervision of a pathologist may, when carrying out a non-coronial post-mortem examination in accordance with subsection (1), be assisted (whether by way of technical or clinical assistance) in carrying out such examination by an appropriately qualified healthcare professional or other person who, in the opinion of the pathologist carrying out or supervising the non-coronial examination, is sufficiently qualified or has the relevant training to provide such assistance.

(3) Where a non-coronial post-mortem examination has been carried out in accordance with subsection (1) the pathologist who carried out the examination shall maintain, or cause to be maintained, a written record of any part of a body retained in accordance with section 46(3).

(4) A person who contravenes—

(a) subsection (1), or

(b) subsection (3),

shall be guilty of an offence.

(5) In this section, “technical or clinical assistance” in relation to the carrying out of a non-coronial post-mortem examination, includes, the removal by a person providing the assistance, of a part of a body from the deceased adult, child or foetus, the subject of the examination concerned.

46. Report of post-mortem examination

46. (1) A pathologist who has carried out or supervised a non-coronial post-mortem examination in accordance with section 45 shall make a report, in writing, of the examination (in this Part referred to as a “post-mortem examination report”).

(2) A post-mortem examination report shall contain information obtained as a result of the non-coronial post-mortem examination including the findings of the examination and such other matters as may be provided for in guidelines.

(3) A copy of a report under subsection (1) shall—

(a) be retained—

(i) with the medical records of the deceased adult or child, the subject of that non-coronial post-mortem examination, or

(ii) in the case of a non-coronial post-mortem examination of a foetus, in accordance with the procedures of the hospital concerned and any guidelines made in that regard,

and

(b) be retained for such period as shall be prescribed under section 40, by the hospital in which the non-coronial post-mortem examination takes place and shall, during that period, be made available, on request, to a person who gave consent under section 47, 48 or 49.

47. (1) An adult may, prior to his or her death, consent to post-mortem activities to be performed on his or her body after his or her death.

(2) When it is proposed to carry out post-mortem activities on a deceased adult who has not consented to post-mortem activities in accordance with subsection (1), a designated healthcare worker shall seek post-mortem consent for the post-mortem activities from the designated family member of the deceased adult and the designated family member may consent to the post-mortem activities concerned.

(3) Where a designated family member is considering whether to provide post-mortem consent under subsection (2), the designated family member shall consider whether or not he or she believes that the deceased person would have objected to the post-mortem activities concerned.

48. (1) When it is proposed to carry out post-mortem activities on a deceased child, a designated healthcare worker shall seek post-mortem consent for the post-mortem activities from a parent or guardian of the child and the parent or guardian may consent to the post-mortem activities concerned.

(2) A parent or guardian of a deceased child may consent to post-mortem activities on the deceased child notwithstanding that the parent has not yet attained the age of 18 years.

(3) A parent or guardian, when providing post-mortem consent under subsection (1), shall have regard to any previously expressed wishes of the deceased child, in proportion to the child’s age, degree of maturity and decision-making capacity at the time of expressing those wishes.

(4) Where one of the parents or guardians of a deceased child has provided post-mortem consent in accordance with subsection (1) (“the first parent or guardian”) and the other parent or guardian objects to the consent provided by the first parent or guardian, the post-mortem activities shall not proceed.

49. (1) When it is proposed to carry out post-mortem activities on a foetus, a designated healthcare worker shall seek post-mortem consent for the post-mortem activities from the mother of the foetus or a person acting on her behalf and the mother, or person acting on her behalf, may consent to the post-mortem activities concerned.

(2) Where the mother of the foetus has not yet attained the age of 18 years she may, notwithstanding that fact, consent to post-mortem activities on the foetus.

50. (1) Where it is intended that a part of a body of—

(a) a deceased child,

(b) a deceased adult, or

which is removed during a non-coronial post-mortem examination be retained and used for commercial purposes, including use by a pharmaceutical company, the person in charge of the hospital concerned shall in accordance with guidelines first give his or her approval.

(2) Subject to subsection (10), a person in charge of a hospital may where he or she is satisfied it is appropriate to do so, and, in accordance with guidelines, approve the retention of a part of a body of a deceased child, deceased adult or deceased foetus for commercial use.

(3) Subject to section 41 and the provisions of this section, an approval given under subsection (2), is approval for the commercial use of that part of the body.

(4) Where the person in charge of a hospital has, in accordance with guidelines, approved the retention of a part of a body for commercial use under subsection (2) in respect of a deceased child, a registered medical practitioner shall seek post-mortem consent from a parent or guardian of the deceased child for the use of such part of a body for commercial purposes and, notwithstanding such approval, unless such consent is obtained, the part of a body shall not be used for those purposes.

(5) Where the person in charge of a hospital has, in accordance with guidelines, approved the retention of a part of a body for commercial use under subsection (2) in respect of a deceased adult, a registered medical practitioner shall seek post-mortem consent from a designated family member for the use of such part of a body for commercial purposes and, notwithstanding such approval, unless such consent is obtained, the part of a body shall not be used for those purposes.

(6) Where the person in charge of a hospital has approved the retention of a part of a body for commercial use under subsection (2), in respect of a deceased foetus, a registered medical practitioner shall seek post-mortem consent from the mother of the foetus or a person acting on her behalf for the use of such part of a body for commercial purposes and, notwithstanding such approval, unless such consent is obtained, the part of a body shall not be used for those purposes.

(7) Where post-mortem consent has been provided in accordance with subsection (4), (5) or (6) and the part of a body retained from a non-coronial post-mortem examination is supplied to a third party, any arrangement in relation to such supply shall, in accordance with guidelines, be recorded and approved in writing by the person in charge of the hospital in which the non-coronial post-mortem examination took place.

(8) Records referred to in subsection (7) shall be retained by the hospital for such period as shall be prescribed under section 40.

(9) Without prejudice to the generality of section 6, the Minister shall issue guidelines in relation to the procedures for approval for the retention of parts of a body for commercial purposes.

(10) A person or hospital shall not receive financial compensation or other non-financial inducements for any part of a body removed during a non-coronial post-mortem examination.

(11) In this section, “person in charge” means, in relation to a hospital—

(a) the chief executive officer (howsoever described) of the hospital,

(b) the owner of the hospital, or

(c) a suitably qualified person specified in that behalf for the purposes of this Act by a person referred to in paragraph (a).

51. Application by Minister to High Court

51. (1) The Minister may make an application to the High Court (in this section referred to as the “Court”) to seek an order permitting a non-coronial post-mortem examination on a deceased adult, child or foetus, without post-mortem consent under section 47, 48 or 49, as the case may be, in exceptional circumstances including—

(a) where such non-coronial post-mortem examination is required in the interests of public health, and

(b) where there is a risk to public health if a non-coronial post-mortem examination is not carried out.

(2) The Court may make an order permitting a non-coronial post-mortem examination on a deceased adult, child or foetus, dispensing with the requirement of post-mortem consent where the court is satisfied that there are such exceptional circumstances as to warrant the making of the order.

(3) The Court shall not make an order under subsection (2) where it is satisfied that to do so would be contrary to the public interest.

(4) When the Court is determining whether or not to dispense with the requirement of post-mortem consent in accordance with subsection (2), the Court shall have due regard—

(a) in the case of a deceased adult—

(i) to the rights and concerns of the designated family member, and

(ii) to the rights and views of the deceased adult (if known),

(b) in the case of a deceased child, to the rights and concerns of the parents or guardians of the deceased child and, if known, the rights and views of the deceased child,

(c) in the case of a deceased foetus, to the rights and concerns of the mother of the deceased foetus or, in a case where the mother is deceased, to the rights and concerns of the designated family member of the deceased mother and, if known, the rights and views of the deceased mother,

(d) to the significance and urgency of the matter the subject of the decision,

(e) to the risk to public health in not conducting a non-coronial post-mortem examination on the deceased adult, child or foetus, the subject of the application, and

(f) to any other matter the court considers appropriate having regard to the circumstances of the application.

(5) Subject to subsection (6), notice of every application under this section shall be given to—

(a) where the subject of the application is a deceased adult, the designated family member of the deceased adult,

(b) where the subject of the application is a deceased child, the parent or guardian of the deceased child, or

(c) where the subject of the application is a deceased foetus, the mother of the deceased foetus, or, where the mother is deceased, the designated family member of the deceased mother.

(6) The Court may give directions relating to the manner of giving notice to a person under this section and may deem any notice given to be sufficient or may, on sufficient cause being shown, dispense with the giving of notice of the application.

52. Nominated person

52. (1) A hospital at which post-mortem activities or coronial post-mortem examinations, as the case may be, take place or will take place shall, subject to subsection (2), as soon as practicable after the commencement of this section and, in any event, not later than 12 weeks after such commencement, nominate in writing at least one suitably qualified person for the purposes of this Part (in this Part referred to as a “nominated person”).

(2) A nominated person shall be an employee of the hospital concerned and shall be a suitably qualified person by reason of his or her training and experience to discharge the responsibilities of a nominated person.

(3) A nominated person shall have the following responsibilities namely:

(a) to ensure that an internal audit of post-mortem activities or coronial post-mortem examinations that take place in the hospital is maintained;

(b) to ensure that an annual report of post-mortem activities or coronial post-mortem examinations that take place in the hospital is compiled and submitted to the Authority;

(d) without prejudice to the powers of the Authority under this Part to monitor compliance with this Part, to notify the Authority in writing when he or she becomes aware of any breach of a provision of this Part;

(e) to liaise with the Authority from time to time and when requested to do so by the Authority.

(4) A hospital in which post mortem activities or coronial post mortem examinations take place or will take place shall inform the Authority of the name and particulars of the person nominated under subsection (1).

(5) A nominated person shall, in accordance with any guidelines, notify the Authority as soon as practicable, but no later than 3 months after the commencement of this section, of the post-mortem activities which take place in the hospital in relation to which he or she is the nominated person.

(6) A hospital at which post-mortem activities or coronial post-mortem examinations take place shall, notwithstanding the nomination by the hospital of a nominated person, at all times remain responsible for, and accountable to the Authority in respect of, compliance with this Part.

53. **Authority to monitor compliance with Part 3 authorised persons, etc.**

53. (1) The Authority shall monitor compliance with this Part.

(2) An authorised person appointed under section 70 of the Health Act 2007 shall be deemed to be an authorised person for the purposes of this Part.

(3) The Health Act 2007 is amended—

(a) in section 2, by the insertion of the following definitions:

“ ‘Act of 1962’ means the Coroners Act 1962;

‘coronial post-mortem examination’ has the same meaning as it has in section 38 of the Act of 2024;

‘non-coronial post-mortem examination’ has the same meaning as it has in section 38 of the Act of 2024;

‘relevant facility’ has the same meaning as it has in section 2 of the Act of 1962;

‘relevant sections of the Act of 1962’ means sections 33(2B), 33(2C), 33(2D), 33(3A), 33(3B), 33(3C), 33(3D), 33F, 33G, 33H, 33I, 33J, 33K, 33L, 33M, 33N and 33O”;

(b) in section 8(1)—

(i) in paragraph (n), to substitute “(S.I. No. 256 of 2018);” for “(S.I. No. 256 of 2018).”, and

(ii) by the insertion of the following paragraphs after paragraph (n):

“(o) to monitor compliance with Part 3 of the Act of 2024 and any regulations made under that Part;

(p) to monitor compliance with the relevant sections of the Act of 1962 and with any regulations made by the Minister for Justice under section 33I of that Act.”.

“Provision of information to Authority for purposes of monitoring compliance with Part 3 of Act of 2024 and relevant sections of Act of 1962 in accordance with subsection (1)(o) and (1)(p) of section 8

12A. (1) A hospital, within the meaning of section 39 of the Act of 2024, at which post-mortem activities or coronial post-mortem examinations take or will take place shall, as soon as practicable after the commencement of this section and in any event, not later than 3 months after such commencement, notify the Authority in writing of the following, namely:

(a) the name and particulars of the nominated person nominated in that behalf pursuant to section 52 of the Act of 2024;

(b) in the case of a hospital where post-mortem activities or coronial post-mortem examinations take place or will take place, the name and address of the hospital;

(c) in the case of a hospital where post-mortem activities or coronial post-mortem examinations take place or will take place, the details of post-mortem activities or coronial post-mortem examinations that take place or will take place on the premises.

(2) Where the hospital changes in a material way any of the matters notified under subsection (1), the hospital shall as soon as possible and, in any event, not later than 28 days after the material changes, inform the Authority in writing and provide it with details of the changes.

(3) Without prejudice to the generality of subsection (1), the Authority may require the Executive or the hospital at which the post-mortem activities or coronial post-mortem examinations take place or will take place to provide it within such reasonable period as the Authority may require with any information or statistics the Authority requires in order to determine the level of compliance by the Executive or hospital with Part 3 of the Act of 2024.

(4) Where a person receives a request under subsection (3) from the Authority, he or she shall comply with such request.”,

(d) in section 70—

(i) in subsection (1)(a), by the substitution of “section 8(1)(c),” for “section 8(1)(c), or”,

(ii) by the insertion, in subsection (1), of the following paragraphs after paragraph (b):

“(c) monitoring compliance with Part 3 of the Act of 2024 in accordance with section 8(1)(o), or

(d) monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act,”,

(iii) in subsection (2)(a), by the substitution of “section 8(1)(c),” for “section 8(1)(c), or”, and

(iv) by the insertion, in subsection (2), of the following paragraphs after paragraph (b):

“(c) monitoring compliance with Part 3 of the Act of 2024 in accordance with section 8(1)(o), or

(d) monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act.”,

(e) in section 73—

(i) by the substitution of the following subsection for subsection (1):

“(1) If an authorised person considers it necessary or expedient for the purposes of—

(a) monitoring compliance with standards in accordance with section 8(1)(c),

(b) an investigation referred to in section 8(1)(d),

(d) monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act,

the authorised person may enter and inspect at any time—

(i) any premises owned or controlled by the Executive, the Agency or a service provider,

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

(iii) any relevant facility.”,

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

“(3A) If an authorised person considers it necessary or expedient for the purposes of monitoring compliance—

(a) with Part 3 of the Act of 2024 in accordance with section 8(1)(o), or

(b) with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act in accordance with section 8(1)(p),

the authorised person, at any time, may carry out the functions conferred on the authorised person under this section and sections 75 and 76 to the extent that the functions relate to any premises referred to in subsection (1).”,

(iii) in subsection (4)—

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

“(a) inspect, take copies of or extracts from and remove from the premises any documents or records (including personal records) relating to the discharge of its functions by the Executive or the Agency or the discharge of the functions of the coroner in so far only as it relates to monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act, or to the services provided by a service provider or at a designated centre,”,

and

(II) in paragraph (c)(i), by the substitution of “section 8(1)(d), or monitoring compliance with Part 3 of the Act of 2024 in accordance with section 8(1)(o), or monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act” for “section 8(1)(d)”,

(iv) in subsection (5)(b)—

(I) in subparagraph (i), by the substitution of “section 8(1)(d), or monitoring compliance with Part 3 of the Act of 2024 in accordance with section 8(1)(o) or monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act,” for “section 8(1)(d)”, and

(II) in subparagraph (ii), by the substitution of “investigation or to the monitoring of compliance with regulations or,” for “investigation or,”,

and

(v) in subsection (7)—

(I) in paragraph (a), by the substitution of “section 8(1)(c),” for “section 8(1)(c), or”, and

(II) by the insertion of the following paragraphs after paragraph (b):

“(c) monitoring compliance with Part 3 of the Act of 2024 in accordance with section 8(1)(o), or

(d) monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act,”,

(f) in section 75—

(i) in subsection (1)(a), by the substitution of “section 8(1)(d) or monitoring compliance with Part 3 of the Act of 2024 in accordance with section 8(1)(o) or monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act” for “section 8(1)(d)”, and

(ii) in subsection (2)(a)(i), by the substitution of “section 8(1)(d) or monitoring compliance with Part 3 of the Act of 2024 in accordance with section 8(1)(o) or monitoring compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act” for “section 8(1)(d)”,

and

(g) in section 77A(2), to substitute the following paragraph for paragraph (a):

“(a) the monitoring of compliance with standards under section 8(1)(c), compliance with Part 3 of the Act of 2024 under section 8(1)(o) and compliance, under section 8(1)(p), with the relevant sections of the Act of 1962 and any regulations made by the Minister for Justice under section 33I of that Act,”.

54. Compliance notices

54. (1) Where an authorised person is of the opinion that there is non-compliance by a person with a requirement of provisions of this Part or any regulations made under it, the authorised person may, following consultation with the Chief Executive Officer of the Authority or such other officer of the Authority so designated for that purpose, serve, or cause to be served, on the person concerned a notice (in this Part referred to as a “compliance notice”) in accordance with this section.

(2) A compliance notice shall be signed by the authorised person who is issuing the notice or the person referred to in subsection (1) whom he or she consulted with in relation to the notice concerned and shall—

(a) specify the requirement of this Part or the regulations made thereunder with which there has not been compliance,

(b) for the purposes of ensuring compliance by the person concerned, require the person by such date as is specified in the notice to do or refrain from doing such act or acts as is or are so specified in the notice,

(c) contain information regarding the bringing of an appeal under section 55 against the notice, including information on the manner in which any such appeal shall be brought.

(3) A compliance notice shall, unless an appeal is brought under section 55, come into operation on the expiry of 14 days from the date of service of the notice.

(4) Where a person on whom a compliance notice has been served fails to comply with the notice at any time on and after the date on which the notice comes into operation, he or she shall be guilty of an offence and shall be liable on summary conviction to a class C fine or imprisonment for a term not exceeding one year or both.

(5) Summary proceedings for an offence under subsection (4) may be brought and prosecuted by the Authority.

55. Appeal of compliance notice

55. (1) A person on whom a compliance notice has been served may within 14 days of service of the compliance notice appeal to the District Court in respect of the notice or any requirement therein.

(2) Where an appeal is brought under this section, the District Court may—

(a) confirm the compliance notice, or

(b) direct the authorised person to withdraw the compliance notice concerned.

(3) Where the District Court makes an order under subsection (2)(b), the compliance notice shall cease to have effect.

(4) Where the District Court confirms a compliance notice, the notice as so confirmed, shall come into operation on the expiry of 14 days of the date of confirmation or such later date as the court may determine.

(5) The jurisdiction conferred on the District Court under this section shall be exercised by a judge of that court for the time being assigned to the district court district in which the person on whom the compliance notice is served ordinarily resides or carries on any profession, business or occupation.

56. Prohibition orders

56. (1) Where an authorised person is of the opinion that—

(a) there is a serious and material non-compliance with a requirement of the provisions of this Part or the regulations made thereunder, and

(b) there is—

(i) a need in the public interest to immediately cease any or all of the post mortem activities or coronial post-mortem examinations, the subject of opinion concerned, or

(ii) a failure to comply with a compliance notice,

the authorised person may, with the approval of the Chief Executive Officer of the Authority, or another officer of the Authority designated for that purpose, serve, or arrange to have served, on the person concerned, an order (in this Part referred to as a “prohibition order”) in accordance with subsection (2).

(2) A prohibition order shall be signed by the authorised person issuing it, or the person referred to in subsection (1) who approves the issuing of the prohibition order and shall—

(a) state that the authorised person is of the opinion that one or more of the grounds specified in subsection (1) for the serving of a prohibition order exists,

(b) specify the particular serious and material non-compliance, public interest need or failure, as the case may be, at issue,

(d) as appropriate, direct the person served with the order to cease, or arrange for the cessation of any or all of the post-mortem activities or coronial post-mortem examinations specified in the order concerned.

(3) The approval referred to in subsection (1) may be given orally or in writing and if given orally shall be recorded in writing as soon as practicable.

(4) A prohibition order shall take effect—

(a) where the prohibition order so declares, immediately upon receipt of the order by the person on whom it is served, or

(b) in any other case—

(i) where no appeal is taken against the prohibition order, on the expiration of the period during which such an appeal may be taken or the day specified in the prohibition order as the day on which it is to come into effect, whichever is the later, or

(ii) where an appeal is taken, on the day next immediately following the day on which the prohibition order is confirmed on appeal or withdrawn or the day specified in the prohibition order as the date on which it is to come into effect, whichever is the later.

(5) The bringing of an appeal against a prohibition order which is to take effect in accordance with subsection (4)(a) shall not have the effect of suspending the operation of the prohibition order, but the appellant may apply to the District Court to have the operation of the prohibition order suspended until the appeal is disposed of and, on such application, the District Court may, if it thinks it proper to do so, direct that the operation of the prohibition order be suspended until the appeal is concluded.

(6) In the event of non-compliance or delay by the person on whom the prohibition order has been served, an authorised person shall, with the approval of the Chief Executive Officer or another officer designated for that purpose by the Authority, take whatever steps are considered necessary to ensure compliance with the direction given under this section.

(7) A person on whom a prohibition order is served who is aggrieved by a prohibition order may, within the period of 7 days beginning on the day on which the prohibition order is served on him or her, appeal against the order to a judge of the District Court in the District Court district in which the prohibition order was served on him or her and, in determining the appeal the judge may—

(a) if he or she is satisfied that in the circumstances of the case it is reasonable to do so, confirm the prohibition order, with or without modification, or

(b) where he or she is not so satisfied of the matters referred to in paragraph (a), allow the appeal and cancel the prohibition order.

(8) Where on the hearing of an appeal under this subsection a prohibition order is confirmed, notwithstanding subsection (5), the judge of the District Court by whom the appeal is heard may, on the application of the appellant, suspend the operation of the prohibition order for such period as in the circumstances of the case the judge considers appropriate.

(9) A person who appeals against a prohibition order or who applies for a direction suspending the application of the prohibition order under subsection (5) shall at the same time notify the Authority of the appeal or the application and the grounds for the appeal or the application and the Authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal or the application.

(10) The Board of the Authority shall be notified at the next available meeting of the Board of the service of a prohibition order.

(11) The Chief Executive Officer of the Authority may, for stated reasons, revoke or vary a prohibition order made in accordance with this section and the Board shall be notified at the next available meeting of the Board of any such revocation or variation and the reasons therefore.

(12) The Chief Executive Officer of the Authority shall, in the public interest make such arrangements as he or she considers necessary or appropriate to bring the matter giving rise to a prohibition order to the attention of the public.

(13) (a) Where a prohibition order has been served and activities are carried on in contravention of the prohibition order, the High Court may, on the application to it in that behalf by the Authority, by order prohibit the continuance of the activities.

(b) An application to the High Court for an order under this paragraph shall be by motion and the Court, when considering the matter, may make such interim or interlocutory order (if any) as it considers appropriate and the order by which an application under this paragraph is determined may contain such terms and conditions (if any) as to the payment of costs as the Court considers appropriate.

Chapter 3 Amendments of Act of 1962

57. Amendment of section 2 of Act of 1962

57. Section 2 of the Act of 1962 is amended by—

(a) the insertion of the following definitions:

“ ‘Authority’ means the Health Information and Quality Authority;

‘designated person’ means—

(a) in relation to a hospital, the person designated in that behalf by the hospital concerned to receive and act in accordance with authorisations from family members of deceased persons under section 33F, and

(b) in relation to a relevant facility, the person designated in that behalf to receive and act in accordance with authorisations from family members of deceased persons under section 33F;

‘Executive’ means the Health Service Executive;

‘healthcare professional’ means—

(a) a registered medical practitioner,

(b) a registered nurse or registered midwife within the meaning of section 2(1) of the Nurses and Midwives Act 2011, or

(c) a member of one or more of the following designated professions within the meaning of section 3 of the Health and Social Care Professionals Act 2005, namely:

(i) medical scientist;

(ii) psychologist;

(iii) social care worker;

(iv) social worker;

(v) such other designated profession within the meaning of the said section as the Minister considers appropriate and may prescribe by regulations;

‘hospital’ has the same meaning as it has in section 39 of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024;

‘operator’ means, in relation to a relevant facility, the person who has ultimate responsibility for the running of the relevant facility;

‘register of relevant facilities’ shall be construed in accordance with section 33J;

‘relevant facility’ means—

(a) the Dublin District Mortuary, or

(b) any other facility (howsoever described), other than a hospital, where post-mortem examinations take place in accordance with this Act and which is specified in the register of relevant facilities as being such place;

‘relevant sections’ means sections 33(2B), 33(2C), 33(2D), 33(3A), 33(3B), 33(3C), 33(3D), 33F, 33G, 33H, 33I, 33J, 33K, 33L, 33M, 33N and 33O;”,

and

(b) by the substitution of the following definition for the definition of “stillborn child”:

“ ‘stillborn child’ has the same meaning as it has in the Act of 2004;”.

58. Amendment of section 33 of Act of 1962

58. Section 33 of the Act of 1962 is amended—

(a) by the insertion of the following subsections after subsection (2):

“(2A) A registered medical practitioner may, when carrying out a post mortem examination in accordance with subsection (1), be assisted (whether by way of technical or clinical assistance) in carrying out such examination by an appropriately qualified healthcare professional or other person who, in the opinion of the registered medical practitioner carrying out or supervising the examination, is sufficiently qualified or has the relevant training or experience to provide such assistance.

(2B) A registered medical practitioner may under a direction in subsection (1), for the purposes of the post-mortem examination, remove and retain for such period any material from the body, as appears to the registered medical practitioner to relate to the circumstances of the death, including the cause of death of the deceased person.

(2C) Where the post-mortem examination has been conducted in a hospital, any material removed from the body under a direction in subsection (1) shall be preserved, stored and recorded in accordance with regulations made in that regard by the Minister for Health under section 40 of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024.

(2D) Where the post-mortem examination has been conducted in a relevant facility, any material removed from the body under a direction in subsection (1) shall be preserved, stored and recorded, in accordance with regulations made in that regard by the Minister under section 33I.”.

(b) by the insertion of the following subsections after subsection (3):

“(3A) In providing the information under subsection (3), a coroner shall notify or cause to be notified a family member of the deceased person, the subject of the information, that approval by the family member (in this Act referred to as an ‘authorisation’) will be sought in respect of the final management of certain material of the deceased person.

(3B) Subsequent to the information being provided to a family member under subsection (3), the coroner shall further notify or cause to be notified the family member concerned that certain material has been retained for the purposes of the post-mortem examination.

(3C) Where at any time following a post-mortem examination, a coroner on foot of receipt of confirmation from a registered medical practitioner directed to make that examination is satisfied that retention of material from the body of the deceased is no longer necessary, or where the provisions of section 33(4) apply, he or she shall notify or cause to be notified a family member of the deceased person of that fact.

(3D) A notification under subsection (3C) shall inform the family member, the recipient of the notification of the following, namely:

(a) that the coroner has requested the designated person in the hospital or relevant facility where the post-mortem examination took place to contact the family member;

(b) the contact details of the designated person;

(c) that the designated person will request an authorisation from the family member for the final management of certain material retained following that examination;

(d) the authorisation for final management of material shall provide for—

(i) the return of material removed from the body where such return is consistent with guidelines, but shall not include tissue samples held on slides or blocks or trimmings or bodily fluids removed during the post-mortem examination,

(ii) the disposal of the material, by the designated person in a hospital or relevant facility, or

(iii) the use, by the hospital or relevant facility, of the material to further clinical teaching, medical education or research prior to ultimate disposal.”,

“(6) The Minister may prescribe the form of notification under this section.

(7) In this section, ‘technical or clinical assistance’, in relation to the carrying out of a post-mortem examination, includes the removal by a person providing the assistance, of a part of a body from the deceased adult, child or foetus, the subject of the examination concerned.”.

59. Amendment of section 33B of Act of 1962

59. Section 33B of the Act of 1962 is amended by the deletion of subsection (1).

60. Further amendment of Act of 1962

60. The Act of 1962 is amended by the insertion of the following sections after section 33E:

“Authorisation for final management of material removed from body of deceased person

33F. (1) Where—

(a) a post-mortem examination of a deceased person has taken place in a hospital or relevant facility, and

(b) the designated person in the hospital or relevant facility has been requested by or on behalf of the coroner to request an authorisation from a family member of the deceased person, the subject of the post-mortem examination,

the designated person in the hospital or relevant facility where the post-mortem examination took place shall request an authorisation from the family of the deceased person, the subject of the post-mortem examination, for the final management of certain material from the body of the deceased person which was retained following that examination.

(2) The designated person shall ensure, in so far as practicable, that the authorisation shall be provided in the terms referred to in section 33(3D)(d)(i), (ii) or (iii) in respect of the final management of the material concerned.

(3) When an authorisation is received by a designated person in respect of the final management of material, he or she shall, as soon as practicable—

(a) give effect to the authorisation,

(b) notify the coroner concerned that the authorisation has been so given effect, and

(4) Where no authorisation is received by the designated person under subsection (3) or where efforts to contact family members of the deceased have not proved successful, the designated person shall inform the coroner concerned of that fact and the coroner shall be authorised to direct the final management of the material concerned by the designated person.

(5) The final management of any material, other than material referred to in section 33(3D)(d)(i), removed from the body of a deceased person shall not be made where the coroner concerned is satisfied that such material may be required for evidential purposes in a relevant legal process and has notified the designated person in that regard.

(6) The management of any material stored—

(a) in a hospital shall be carried out in accordance with regulations made in that regard by the Minister for Health under section 40 of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024, or

(b) in any relevant facility shall be carried out in accordance with regulations made in that regard by the Minister.

Provisions to apply when no authorisation received for final management of material removed from body of deceased person

33G. In a case to which section 33F(4) applies, the coroner shall direct that the final management of the material concerned be carried out by the designated person, or such other person as appears to the coroner to be appropriate in the hospital or relevant facility, as the case may be, where the material is stored, in accordance with section 33(3D)(d)(ii) or (iii) as is appropriate in the circumstances.

Provisions to apply when designated person not available or in position to receive or to act on authorisation for final management of material removed from body of deceased person

33H. (1) Where a coroner is notified or otherwise becomes aware that a designated person is not available or not otherwise in a position to receive or act in accordance with an authorisation for the final management of material removed from the body of a deceased person, the coroner shall—

(a) seek or confirm the authorisation of the family member in respect of the final management of certain material removed from the body of the deceased person, the subject of the authorisation, and

(b) direct the final management of the material in accordance with the authorisation received.

(2) When the coroner has completed the matters referred to in subsection (1), he or she shall endeavour in so far as is practicable to make this information available to the family member of the deceased should it be so requested.

Regulations in respect of management of material retained following coronial post-mortem examinations made in relevant facilities

33I. (1) Without prejudice to the generality of section 3, the Minister may make such regulations as he or she considers necessary or expedient for the purpose of proper management in the most respectful and appropriate manner possible of material retained in the course of coronial post-mortem examinations that are made in relevant facilities.

(2) In particular, but without prejudice to the generality of subsection (1), regulations under subsection (1) may provide for any or all of the following matters:

(a) procedures for the retention, storage and management of material removed from the body as part of the coronial post-mortem examination, where such action is consistent with any guidelines made in that regard;

(b) the arrangements to be put in place to facilitate receipt of notification of authorisations under section 33F(1), including the designation of persons or classes of persons to whom such notifications shall be given and the procedures for the carrying out of authorisations received in that regard;

(c) the return of any material referred to in paragraph (a) to a family member of the deceased person other than tissue samples held on slides or blocks or trimmings or bodily fluids removed during the examination;

(d) the form of notifications under sections 33(3B), 33(3C) and 33(3D);

(e) the form of authorisations under 33F;

(f) the form of notification of details of relevant facilities under section 33J;

(g) any additional information as the Minister considers may reasonably be required for the purposes of the register of relevant facilities;

(h) the particulars of notification of incidents to be declared to the Authority;

(i) any other matters which are necessary or expedient for the purposes of giving effect to subsection (1).

(3) Before making regulations under subsection (1), the Minister shall consult such persons as he or she considers appropriate, including all or any of the following:

(a) a representative of the Coroners Society of Ireland;

(b) a pathologist from the Royal College of Physicians of Ireland, Faculty of Pathology;

(d) the Executive;

(e) the Authority;

(f) the Minister for Health.

Register of relevant facilities

33J. (1) As soon as may be after the commencement of this section, the Minister shall—

(a) request in writing each coroner who is for the time being holding office to provide the Minister in such form and manner as may be prescribed and within such period as may be prescribed details of any relevant facility where the coroner directs post-mortem examinations to be made in accordance with this Act, and

(b) establish and maintain in such form as he or she considers appropriate, a register of relevant facilities (in this Act referred to as the ‘register of relevant facilities’) to which the regulations under section 33I shall apply.

(2) Where a coroner receives a request in writing under subsection (1)(a), the coroner shall comply with that request.

(3) Notwithstanding the generality of subsection (1)(a), where, at any time, a coroner is of reasonable opinion that a facility (howsoever described) where he or she directs post-mortem examinations to be made in accordance with this Act is a relevant facility, he or she shall notify the Minister in writing of that opinion for the purpose of having that facility registered in the register of relevant facilities.

(4) The register of relevant facilities shall contain the following information, namely:

(a) the name of the relevant facility;

(b) the location of the relevant facility;

(d) the chief executive officer (howsoever described) of the relevant facility;

(e) the nominated person in relation to the relevant facility;

(f) any additional information as the Minister considers may reasonably be required and as may be prescribed under section 33I.

(5) If a particular entered in the register of relevant facilities is incorrect, the coroner in respect of the relevant facility to which the particular relates shall, as soon as may be after becoming aware of its being incorrect, inform the Minister thereof accordingly.

(6) The Minister shall, at regular intervals as may be agreed between the Minister and the Authority and, in any event, when a material change is made to the register, provide a copy of the register to the Authority.

Nominated person

33K. (1) Subject to subsection (2), a relevant facility at which post-mortem examinations take place shall, as soon as practicable after the commencement of this section and, in any event, not later than 12 weeks after such commencement, nominate in writing at least one suitably qualified person for the purposes of the relevant sections (in this section referred to as a ‘nominated person’).

(2) A nominated person shall be an employee of the relevant facility concerned and shall be suitably qualified person by reason of his or her training and experience to discharge the responsibilities of a nominated person.

(3) A nominated person shall have the following responsibilities, namely:

(a) to notify, in accordance with any guidelines, the Authority of the post-mortem examinations that take place in the relevant facility in relation to which he or she is the nominated person.

(b) to ensure that an annual report of post-mortem examinations that take place in the relevant facility is compiled and submitted to the Authority;

(d) without prejudice to the powers of the Authority under Part 3 of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024 and section 8 of the Health Act 2007, to monitor compliance with the relevant sections and any regulations under section 33I and notify the Authority in writing when he or she becomes aware of any breach of a provision of those sections or regulations;

(e) to liaise with the Authority from time to time and when requested to do so by the Authority.

(4) The operator of a relevant facility at which post-mortem examinations take place shall, notwithstanding the nomination by the relevant facility of a nominated person, at all times remain responsible for, and accountable to the Authority in respect of, compliance with regulations under section 33I.

Authority to monitor compliance with relevant sections authorised persons etc.

33L. (1) The Authority shall, pursuant to section 8(1)(p) of the Health Act 2007, monitor compliance with the relevant sections and any regulations made by the Minister under section 33I.

(2) An authorised person appointed under section 70 of the Health Act 2007 shall be deemed to be an authorised person for the purposes of this section.

(3) A relevant facility shall, as soon as practicable after the commencement of section 33K and, in any event, not later than 12 weeks after such commencement, notify the Authority in writing of the following, namely:

(a) the name and particulars of the nominated person nominated in that behalf pursuant to section 33K;

(b) the name and address of the premises at which the post-mortem examinations take place or are intended to take place;

(4) Where a relevant facility changes in a material way any of the matters notified under subsection (3), the relevant facility shall as soon as possible and, in any event, not later than 28 days after the material changes, inform the Authority in writing and provide it with details of the changes.

(5) Without prejudice to the generality of subsection (3), the Authority may require the coroner or relevant facility at which post-mortem examinations take place or will take place to provide it within such reasonable period as the Authority may require with any information or statistics the Authority requires in order to determine the level of compliance by the relevant facility with regulations under section 33I.

(6) Where a person receives a request under subsection (5) from the Authority, he or she shall comply with such request.

Compliance notices

33M. (1) Where an authorised person is of the opinion that there is non compliance by a a relevant facility with the relevant sections or any regulations made under section 33I, the authorised person may, following consultation with the Chief Executive Officer of the Authority or such other officer of the Authority so designated for that purpose, serve, or cause to be served, on the operator of the relevant facility concerned a notice (in this Act referred to as a ‘compliance notice’) in accordance with this section.

(2) A compliance notice shall be signed by the authorised person who is issuing the notice or the person referred to in subsection (1) whom he or she consulted with in relation to the notice concerned and shall—

(a) specify the requirement of the relevant sections or regulations under section 33I with which there has not been compliance,

(b) for the purposes of ensuring compliance by the relevant facility concerned, require the operator of the relevant facility by such date as is specified in the notice to do or refrain from doing such act or acts as is or are so specified in the notice, and

(c) contain information regarding the bringing of an appeal under section 33N against the notice, including information on the manner in which any such appeal shall be brought.

(3) A compliance notice shall, unless an appeal is brought under section 33N, come into operation on the expiry of 14 days from the date of service of the notice.

(4) Where a person on whom a compliance notice has been served fails to comply with the notice at any time on or after the date on which the notice comes into operation, he or she shall be guilty of an offence and shall be liable on summary conviction to a class C fine or imprisonment for a term not exceeding one year or both.

(5) Summary proceedings for an offence under subsection (4) may be brought and prosecuted by the Authority.

Appeal of compliance notice

33N. (1) The operator of a relevant facility on whom a compliance notice has been served may within 14 days of service of the compliance notice appeal to the District Court in respect of the notice or any requirement therein.

(2) Where an appeal is brought under this section, the District Court may—

(a) confirm the compliance notice, or

(b) direct the authorised person to withdraw the compliance notice concerned.

(3) Where the District Court makes an order under subsection (2)(b), the compliance notice shall cease to have effect.

Prohibition orders

33O. (1) Where an authorised person is of the opinion that—

(a) there is a serious and material non-compliance with a requirement of the relevant sections or any regulations under section 33I, and

(b) there is—

(i) a need in the public interest to immediately cease any or all of the post-mortem examinations, the subject of the opinion concerned, or

(ii) a failure to comply with a compliance notice,

the authorised person may, with the approval of the Chief Executive Officer of the Authority, or another officer of the Authority designated for that purpose, serve, or arrange to have served, on the operator of the relevant facility, an order (in this Act referred to as a ‘prohibition order’) in accordance with subsection (2).

(2) A prohibition order shall be signed by the authorised person issuing it, or the person referred to in subsection (1) who approves the issuing of the prohibition order and shall—

(a) state that the authorised person is of the opinion that one or more of the grounds specified in subsection (1) for the serving of a prohibition order exists,

(b) specify the particular serious and material non-compliance, public interest need or failure, as the case may be, at issue,

(d) as appropriate, direct the operator of the relevant facility served with the order to cease, or arrange for the cessation of, any or all of the post-mortem activities specified in the order concerned.

(3) The approval referred to in subsection (1) or subsection (6), as the case may be, may be given orally or in writing and if given orally shall be recorded in writing as soon as practicable.

(4) A prohibition order shall take effect—

(a) where the prohibition order so declares, immediately upon receipt of the order by the person on whom it is served, or

(b) in any other case—

(ii) where an appeal is taken, on the day immediately following the day on which the prohibition order is confirmed on appeal or withdrawn or the day specified in the prohibition order as the date on which it is to come into effect, whichever is the later.

(5) The bringing of an appeal against a prohibition order which is to take effect in accordance with subsection (4)(a) shall not have the effect of suspending the operation of the prohibition order, but the appellant may apply to the District Court to have the operation of the prohibition order suspended until the appeal is disposed of and, on such application, the District Court may, if it thinks it proper to do so, direct that the operation of the prohibition order be suspended until the appeal is concluded.

(6) In the event of non-compliance or delay by the operator of a relevant facility on whom the prohibition order has been served, an authorised person shall, with the approval of the Chief Executive Officer or another officer designated for that purpose by the Authority, take whatever steps are considered necessary to ensure compliance with the direction given under this section.

(7) The operator of a relevant facility on whom a prohibition order is served who is aggrieved by a prohibition order may, within the period of 7 days beginning on the day on which the prohibition order is served on him or her, appeal against the order to a judge of the District Court in the district court district in which the prohibition order was served on him or her and, in determining the appeal, the judge may—

(a) if he or she is satisfied that in the circumstances of the case it is reasonable to do so, confirm the prohibition order, with or without modification, or

(b) where he or she is not so satisfied of the matters referred to in paragraph (a), allow the appeal and cancel the prohibition order.

(8) Where on the hearing of an appeal under this subsection a prohibition order is confirmed, notwithstanding subsection (5), the judge of the District Court by whom the appeal is heard may, on the application of the appellant, suspend the operation of the prohibition order for such period as in the circumstances of the case the judge considers appropriate.

(9) A person who appeals against a prohibition order or who applies for a direction suspending the application of the prohibition order under subsection (5) shall at the same time notify the Authority of the appeal or the application and the grounds for the appeal or the application and the Authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal or the application.

(10) The Board of the Authority shall be notified at the next available meeting of the Board of the service of a prohibition order.

PART 4 Anatomical Examination

61. **Definitions (Part 4)**

61. In this Part—

“anatomical consent” shall be construed in accordance with section 63;

“anatomical examination” means the use of a body, or any part of a body, for the purposes of the study and practice of the science of anatomy;

“anatomical specimen” means a body (including separated parts of such a body)—

(a) intended to be used for anatomical examination in accordance with this Part, or

(b) which is being used for anatomical examination in accordance with this Part;

“applicant institution” has the meaning assigned to it by section 68;

“authorised officer” means a person appointed under section 79;

“body” means the body of a deceased person;

“licensed institution” means an institution licensed by the Medical Council under section 68 in respect of the carrying out of anatomical examinations;

“relevant institution” means any one of the following:

(a) the college of the Holy and Undivided Trinity of Queen Elizabeth near Dublin established by charter dated the 3rd day of March 1592 and shall be held to include the University of Dublin;

(b) Royal College of Surgeons in Ireland;

(d) University College Cork;

(e) University of Galway;

“responsible person” has the meaning assigned to it by section 65.

62. Application of Part

62. This Part shall not apply to a body or a part of a body that was donated pursuant to the provisions of the Anatomy Act 1832 or imported by a relevant institution for the purposes of anatomical examination before the commencement of this section.

63. (1) Subject to subsection (6), an anatomical examination shall not be carried out on a body at a licensed institution unless the institution is in receipt of a consent in respect of that body, given in accordance with this section or section 67, as the case may be.

(2) A person who has attained the age of 18 years may give his or her consent (in this Part referred to as an “anatomical consent”) to the donation of his or her body to a licensed institution for purposes of anatomical examination.

(3) Where a person is considering whether to provide an anatomical consent, the following information shall be provided to him or her by or on behalf of a licensed institution, namely:

(a) the nature of the activities for which a body may be used;

(b) the period of time in respect of which the body (or parts of the body), the subject of the consent may be retained;

(d) information relating to the disposal of the body (including information relating to the repatriation of a body which may be exported);

(e) without prejudice to paragraphs (a) to (d), any other information for the time being specified by the Medical Council as being necessary information to be given to a person who is considering providing his or her consent under this section.

(4) An anatomical consent shall be given in the form for the time being standing specified by the Medical Council for that purpose and without prejudice to the generality of the foregoing shall—

(a) be in writing,

(b) be signed by the person in the presence of at least one witness who shall attest the signature,

(c) include a confirmation by the person concerned that he or she has been furnished with, and understands, the information referred to in paragraphs (a) to (e) of subsection (3),

(d) indicate whether the person consents to his or her body being loaned or transferred in accordance with any authorisation given in that behalf to the institution by the Medical Council, and

(e) specify the period of time that the person consents to his or her body being used for the purposes of anatomical examination.

(5) An anatomical consent given by a person may be revoked or amended by the person at any time before his or her death in like manner and conditions by notifying in writing, in the form for the time being standing specified by the Medical Council for that purpose, the licensed institution in respect of which the anatomical consent relates, furnishing details of the revocation of, or amendment to, the consent, as the case may be.

(6) A person shall not be entitled to financial or other like reward for the giving of his or her consent under this section other than financial assistance provided after the person’s death in respect of—

(a) the costs of the transportation of the body to the licensed institution in accordance with the procedures in place in the licensed institution,

(b) the provision of a coffin and transportation of the body to the place of burial or cremation, the subject of the consent, or

(c) without prejudice to the generality of paragraph (b), reasonable costs of the transfer or disposal of the person’s body in accordance with the consent given by the person,

and, any financial or other like reward given in respect of an anatomical consent shall render the consent null and void.

(7) Subject to any provision to the contrary provided in an anatomical consent, a licensed institution may bury (whether in a place owned by or under the control of, the licensed institution concerned or in a place designated by the institution for that purpose) the remains, or the cremated remains as the case may be, of a body the subject of a consent.

(8) An anatomical consent given by a person under this section is given for the purposes and only the purposes of anatomical examination.

(9) A copy of the anatomical consent provided under this section shall be—

(a) furnished to the person giving his or her consent, and

(b) retained at the licensed institution which received the body.

(10) A person who contravenes subsection (1) shall be guilty of an offence.

64. Medical certificate of cause of death must be signed before anatomical examination can take place

64. (1) Where a person has consented under section 63 to the use of his or her body after death for the purposes of anatomical examination, the donor’s body may be brought to a licensed institution and embalmed or otherwise preserved before the death has been duly registered in the register of deaths by an tArd-Chláraitheoir.

(2) No anatomical examination shall take place until a medical certificate of the cause of death has been signed and furnished to the licensed institution in respect of the body.

(3) A copy of the medical certificate of the cause of death shall be kept at the licensed institution which received the body for such period as shall be specified in a code of practice under section 81 which period shall not be less than 5 years.

65. Practice of anatomical examination

65. (1) A person who is named on a licence (in this Part referred to as “responsible person”) granted by the Medical Council to a licensed institution or a person who is authorised by, or under the direction of, a responsible person may, in accordance with this Part, carry out or participate in anatomical examinations.

(2) A person shall not carry out anatomical examinations otherwise than in a licensed institution.

(3) Where a donor donates his or her body to a licensed institution, the institution shall be responsible for the donor’s body or part or parts of that body, as the case may be, from the time that the institution accepts the donation for anatomical examination until such time as the body so donated is buried, cremated, disposed of or returned to the donor’s family as may be appropriate.

(4) A person who contravenes subsection (2) shall be guilty of an offence.

66. Loan or transfer of anatomical specimens for purposes of anatomical examination

66. (1) A licensed institution, if it is in receipt of a prior authorisation given to it by the Medical Council, may by agreement loan or transfer an anatomical specimen to another licensed institution or to a like institution in Northern Ireland for the purposes of anatomical examination.

(2) In making an application to the Medical Council for an authorisation, the licensed institution shall specify in writing—

(a) the anatomical specimens that are the subject of the loan or transfer, as the case may be,

(b) the purpose for which the loan or transfer, as the case may be, is being made,

(d) the name and location of the institution where the anatomical specimens will be held.

(3) An anatomical specimen that is on loan under subsection (1) shall remain the responsibility of the lending institution.

(4) An anatomical specimen that is transferred to another licensed institution or to a like institution in Northern Ireland, as the case may be, shall be the responsibility of—

(a) in the case of a transfer to another licensed institution, that other licensed institution, or

(b) in the case of transfer to a like institution in Northern Ireland in accordance with this section, the institution to which it is transferred.

(5) It shall be for both licensed institution which loans or transfers, as the case may be, an anatomical specimen and the licensed institution which receives an anatomical specimen on loan or transfer, as the case be, to show if so requested in writing by the Medical Council that the loan or transfer is made in accordance with this Part and any anatomical consent given by the donor in respect of the specimen concerned.

(6) All records (which shall include a copy of the records referred to in sections 64(3), 67 and 76) relating to an anatomical specimen shall be transferred from the licensed institution which transfers, to the licensed institution or like institution in Northern Ireland, as the case may be, receiving the specimen the subject of the transfer.

(7) A licensed institution which loans or transfers an anatomical specimen under this section shall retain copies of the records transferred under subsection (6) for such period as shall be specified in a code of practice under section 81, which period shall not be less than 5 years.

(8) A licensed institution receiving an anatomical specimen shall be responsible—

(a) in the case of a loan, for the return of that specimen to the licensed institution who made the loan, or

(b) in the case of a transfer, for the disposal of that anatomical specimen in accordance with consent provided under section 63.

67. Importation of anatomical specimens for anatomical examination

67. (1) A licensed institution may, if it is in receipt of prior authorisation issued to it in that behalf by the Medical Council, import anatomical specimens for anatomical examination.

(2) In making an application to the Medical Council for an authorisation, the licensed institution shall specify in writing—

(a) the anatomical specimens that are the subject of the proposed importation,

(b) the purpose for which the proposed importation is being made,

(d) the location at which the anatomical specimens will be held.

(3) An anatomical specimen shall be obtained, transported, used and disposed of by a licensed institution in accordance with any consent given by the donor in respect of the body concerned.

(4) It shall be for the licensed institution to satisfy itself and to show, if so requested in writing by the Medical Council, that the anatomical specimen has been obtained, transported, used and disposed of by the institution concerned in accordance with any consent given by the donor of the specimen concerned.

(5) Where an anatomical specimen is imported into the State by a licensed institution for the purposes of anatomical examination, it shall be for the licensed institution to show, if so requested in writing by the Medical Council, that the institution complied with the legal requirements in the country from which the anatomical specimen has been imported.

(6) Without prejudice to the generality of subsection (4), evidence of compliance referred to in that subsection may comprise of evidence to show that the anatomical specimens have been imported in accordance with rules (howsoever described) relating to anatomical examination and donation of human tissue where such rules are, in the view of the Medical Council, equivalent to the provisions of this Part.

68. Licensed institutions

68. (1) Where, immediately before the commencement of this section, a licence to carry out anatomical examinations is standing issued and for the time being in force under the Anatomy Act 1832 to a person in a relevant institution and—

(a) the relevant institution wishes to continue to carry on anatomical examinations after that commencement, and

(b) the person named on the licence on behalf of the relevant institution or nominated for that purpose by the relevant institution and duly approved in that behalf by the Medical Council is and will for the time being remain in that capacity at the relevant institution,

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Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024

38. Definitions (Part 3)

39. Application of Part

40. Regulations for purposes of Part, including regulations to apply to certain aspects of coronial post-mortem examinations that take place in hospitals

Chapter 2 Consent and post-mortem activities

41. Consent - general provisions

42. Post-mortem activities

43. Removal and retention of organs and other body parts during non-coronial post-mortem examination

44. Purposes for which post-mortem activities may be undertaken

45. Carrying out of non-coronial post-mortem examination

46. Report of post-mortem examination

47. Consent for post-mortem activities on adult

48. Consent for post-mortem activities on deceased child

49. Consent for post-mortem activities on foetus

50. Commercial purposes and consent for use

51. Application by Minister to High Court

52. Nominated person

53. Authority to monitor compliance with Part 3 authorised persons, etc.

54. Compliance notices

55. Appeal of compliance notice

56. Prohibition orders

Chapter 3 Amendments of Act of 1962

57. Amendment of section 2 of Act of 1962

58. Amendment of section 33 of Act of 1962

59. Amendment of section 33B of Act of 1962

60. Further amendment of Act of 1962

PART 4 Anatomical Examination

61. Definitions (Part 4)

62. Application of Part

63. Consent to donate body for anatomical examination

64. Medical certificate of cause of death must be signed before anatomical examination can take place

65. Practice of anatomical examination

66. Loan or transfer of anatomical specimens for purposes of anatomical examination

67. Importation of anatomical specimens for anatomical examination

68. Licensed institutions

38. **Definitions (Part 3)**

53. **Authority to monitor compliance with Part 3 authorised persons, etc.**

61. **Definitions (Part 4)**