Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024
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Further amendment of Act of 1962 | ||
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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 | ||
(c) make this information available to the family member of the deceased should it be so requested by the family member. | ||
(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; | ||
(c) the Chief State Pathologist; | ||
(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; | ||
(c) the operator 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; | ||
(c) to maintain or cause to be maintained records in accordance with regulations under section 33I; | ||
(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; | ||
(c) the post-mortem examinations which take place or are intended to take place on the premises. | ||
(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. | ||
(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. | ||
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, | ||
(c) where relevant, identify the part or parts of the compliance notice with which there has not been compliance, and | ||
(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— | ||
(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 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. | ||
(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.”. |