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

Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge English Produced by the Office of the Attorney General Táirgthe ag Oifig an Ard-Aighne Home Legislation Acts of the Oireachtas Statutory Instruments Pre-1922 Legislation Constitution External Resources Bills (Houses of the Oireachtas) Iris Oifigiúil / Official Gazette Revised Acts (LRC) Classified List of Legislation (LRC) Translations (acts.ie) Translations (Houses of the Oireachtas) Government Publications for Sale EU Law (EUR-Lex) FAQ Disclaimer Feedback Helpdesk Search Baile Reachtaíocht Achtanna an Oireachtais Ionstraimí Reachtúla Reachtaíocht Réamh-1922 Bunreacht Acmhainní Seachtracha Billí (Tithe an Oireachtais) Iris Oifigiúil Achtanna Athbhreithnithe (CAD) (An Coimisiún um Athchóiriú an Dlí) Liosta Rangaithe Reachtaíochta Aistriúcháin (achtanna.ie) Aistriúcháin (Tithe an Oireachtais) Foilseacháin Rialtais ar Díol Dlí AE (EUR-Lex) CCanna (Ceisteanna Coitianta) Séanadh Aiseolas Deasc chabhrach Cuardach TitleTeideal Year(s) or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile ActsAchtanna 2024 Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024 Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024 Permanent Page URL View by SectionAmharc de réir Ailt View Full ActAmharc ar an Acht Iomlán Bill History Stair Bille Commencement, Amendments, SIs made under the Act Tosach Feidhme, Leasuithe, IRí arna ndéanamh faoin Acht Open PDFOscail PDF Print Full ActPriontáil an tAcht Iomlán Number 5 of 2024 HUMAN TISSUE (TRANSPLANTATION, POST-MORTEM, ANATOMICAL EXAMINATION AND PUBLIC DISPLAY) ACT 2024 CONTENTS PART 1 Preliminary and General Section 1. Short title, commencement and collective citation 2. Interpretation 3. Regulations 4. Expenses 5. Service of documents 6. Guidelines 7. Designated family member in relation to relevant person 8. Provisions for storage, handling, transportation, and respectful disposal or return of bodies, anatomical specimens, organs or tissue PART 2 Transplantation Chapter 1 Preliminary and general (Part 2) 9. Interpretation and application 10. Deemed consent and appropriate consent – general provisions 11. Transplantation activities 12. Principles governing organ and tissue and cell donation 13. Priority of organ donation 14. Removal of tissue sample to determine viability of transplantation 15. Preservation for transplantation activities – deceased persons 16. Certification for transplantation activities – deceased donor 17. Review of operation of Relevant Organ Donation Opt-Out Register Chapter 2 Consent 18. Deemed consent for donation of relevant organs and removal of relevant organs 19. Consent for organ donation given by designated family member where deemed consent does not apply 20. Consent for tissues and cells donation given by designated family member in respect of deceased adult donor 21. Consent by parent or guardian in respect of deceased child Chapter 3 Conditions in relation to donation 22. Conditions in relation to donation of organs by living adults 23. Conditions in relation to donation of tissues and cells by living adults 24. Conditions in relation to donation of organs by non-directed altruistic donors 25. Conditions in relation to donation of organs and tissues and cells by living adults who lack capacity 26. Conditions in relation to donation of organs and tissues and cells by living children Chapter 4 Independent panel 27. Independent panel for certain cases of living donation of organs and tissue and cells 28. Composition of Panel 29. Application to Panel for non-directed altruistic donation 30. Application to Panel for donation of regenerative tissue and cells by living adults who lack capacity 31. Application to Panel for donation of regenerative tissue and cells by living child Chapter 5 Relevant Organ Donation Opt-Out Register 32. Relevant Organ Donation Opt-Out Register 33. Application to register objection to being relevant organ donor 34. Application to ascertain if objection registered on Register Chapter 6 Compliance under Part and consequential amendments to Regulations of 2006 and Regulations of 2012 35. Authority to monitor compliance with Part 2 36. Consequential amendments to Regulations of 2006 37. Consequential amendments to Regulations of 2012 PART 3 Pathology Practice Chapter 1 Preliminary and General 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 69. Notification of grant of licence to institution 70. Material amendment of licence 71. Removal, variation or addition of conditions 72. Suspension and revocation of licences 73. Medical Council may suspend licence without notice in certain circumstances 74. Appeal from decision (other than decision under section 73) of Medical Council 75. Responsible persons 76. Records to be kept in relation to donated anatomical specimens 77. Transfer of functions from inspectors of places in State where anatomy is carried on under and in accordance with Anatomy Act 1832 to Medical Council 78. Requests by Medical Council for information 79. Authorised officers for purposes of Part 4 80. Powers of authorised officers (Part 4) 81. Codes of practice (anatomical examination) 82. Compliance notices (anatomical examination) 83. Appeal of compliance notice PART 5 Public Display 84. Definitions (Part 5) 85. Public display activities 86. Licence required for public display activities 87. Consent to donation of body, etc. for public display activities 88. Medical certificate of cause of death must be signed before public display activities can take place 89. Application for Part 5 licence to undertake public display activities 90. Placing of conditions upon licence 91. Suspension and revocation of Part 5 licences 92. Suspension of licence without notice in certain circumstances 93. Appeal from decision (other than decision under section 92) of Medical Council 94. Loan or transfer of anatomical specimens for purposes of public display activities 95. Importation of anatomical specimens for purposes of public display activities 96. Records to be kept in relation to anatomical specimens 97. Medical Council to monitor compliance with provisions of Part 5 98. Authorised officers for purposes of Part 5 99. Powers of authorised officers - Part 5 100. Codes of practice (public display) 101. Compliance notices (public display) 102. Appeal of compliance notice PART 6 Miscellaneous 103. Amendment of Health Act 2004 104. Amendment of Act of 2007 105. Amendment of Act of 2015 106. Repeals 107. Offences and penalties 108. Defences 109. Sharing of information in certain circumstances 110. Data protection Acts Referred to Anatomy Act 1832 (2 & 3 Will., c.75) Assisted Decision-Making (Capacity) Act 2015 (No. 64) Children and Family Relationships Act 2015 (No. 9) Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010 (No. 24) Civil Registration Act 2004 (No. 3) Companies Act 2014 (No. 38) Coroners Act 1962 (No. 9) Coroners Acts 1962 to 2024 Data Protection Act 2018 (No. 7) Guardianship of Infants Act 1964 (No. 7) Health Act 2004 (No. 42) Health Act 2007 (No. 23) Health and Social Care Professionals Act 2005 (No. 27) Health Identifiers Act 2014 (No. 15) Judicial Separation and Family Law Reform Act 1989 (No. 6) Medical Practitioners Act 2007 (No. 25) Nurses and Midwives Act 2011 (No. 41) Petty Sessions (Ireland) Act 1851 (14 & 15 Vict., c.93) Social Welfare Consolidation Act 2005 (No. 26) Number 5 of 2024 HUMAN TISSUE (TRANSPLANTATION, POST-MORTEM, ANATOMICAL EXAMINATION AND PUBLIC DISPLAY) ACT 2024 An Act to provide for the removal, donation and use of organs and tissues and cells from deceased and living persons for the purposes of transplantation; to make provision for the establishment and maintenance of a register in respect of certain organs whereby persons who do not wish to donate certain organs after death may register objection to donation of such organs; to provide for the establishment of a panel of persons to oversee certain proposed donations in respect of certain persons; to make provision for the carrying out of post-mortem examinations in hospitals and other non-hospital settings and the regulation of such activity; to make provision for the donation by living persons of their bodies after death for the purposes of anatomical examination or public display; to provide for the establishment of a licensing system in respect of persons undertaking anatomical examinations or public display activities; to provide that consent is pre-requisite for all procedures involving human organs and tissues and cells and for procedures relating to carrying out of anatomical examinations or public display activities; to make provision for the protection of the bodily integrity of persons before and after death; to provide for the monitoring and enforcement of compliance with these and other matters; and, for these and other purposes, to amend the Assisted Decision Making (Capacity) Act 2015 , the Medical Practitioners Act 2007 , the Coroners Act 1962 , the European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006, the European Union (Quality and Safety of Human Organs intended for Transplantation) Regulations 2012 and certain other enactments; to repeal the Anatomy Act 1832 ; and to provide for related matters [28th February, 2024] Be it enacted by the Oireachtas as follows: PART 1 Preliminary and General Short title, commencement and collective citation 1. (1) This Act may be cited as the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024. (2) Subject to subsection (3), this Act shall come into operation on such day or days as the Minister may appoint by order or orders either generally or with reference to any particular purpose or provision and different days may be so appointed for different purposes or different provisions. (3) Sections 39 (2)(b), and 58 and 60 shall come into operation on such day or days as the Minister may, after consultation with the Minister for Justice, appoint by order or orders either generally or with reference to any particular purpose or provision and different days may be so appointed for different purposes or different provisions. (4) The Coroners Acts 1962 to 2024 and sections 58 and 60 may be cited together as the Coroners Acts 1962 to 2024. Interpretation 2. In this Act— “Act of 1962” means the Coroners Act 1962 ; “Act of 2007” means the Medical Practitioners Act 2007 ; “Act of 2015” means the Assisted Decision-Making (Capacity) Act 2015 ; “adult” means a person who has attained 18 years of age; “anatomical specimen” means the body of a deceased person, including separated parts of such a body, to be used for the purpose of anatomical examination or public display activities; “appropriate consent” has the meaning assigned to it by section 10 ; “Authority”, other than in Part 3 , means the Health Products Regulatory Authority; “body” means the human body; “capacity” means, in relation to a person, his or her decision-making capacity and shall be construed in accordance with section 3 of the Act of 2015; “cells” means individual human cells or a collection of human cells when not bound by any form of connective tissue; “child”, other than in section 7 , means a person who has not attained 18 years of age; “civil partner” has the same meaning as it has in the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010 ; “cohabitant” means one of two adults (whether of the same or opposite sex) who live together as a couple in an intimate and committed relationship and who are not married to each other or civil partners of each other; “consent” means the giving of a permission or an agreement, that is voluntarily and freely given or made, for the use of human cells, organs and tissues— (a) for the purpose of transplantation activities, post-mortem examinations, anatomical examination or public display, as the case may be, and (b) in respect of which purpose, the person giving consent has received information sufficient to allow that person to understand the nature, risks, and benefits of the proposed purpose; “coroner” has the same meaning as it has in section 2(1) of the Act of 1962; “deemed consent” shall be construed in accordance with section 18 ; “designated family member” has the meaning assigned to it by section 7 ; “disposal”, in relation to the body or part of a body of a deceased person, means lawful disposal, either on land or at sea, by burial, cremation, scattering of the ashes of the remains of the body or other appropriate means; “donation” means— (a) in relation to transplantation activities, the donation of human organs for transplantation or human tissues and cells for human application, or (b) in relation to anatomical examination or public display, the donation of the body; “donor” means— (a) in relation to the donation of organs, a person who donates human organs whether or not that donation takes place during the lifetime or after the death of the person, (b) in relation to the donation of tissues and cells, a person who donates tissues and cells, whether or not that donation takes place during the lifetime or after the death of the person, or (c) in relation to the donation of a person’s body for the purposes of anatomical examination or for public display, the person who so donates his or her body for that purpose; “Executive” means the Health Service Executive; “guidelines” means guidelines issued by the Minister under section 6 ; “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 under section 3 ; “human application” means the use of tissues or cells on or in a human recipient and extracorporeal applications; “licensed institution” has the meaning assigned to it by section 61 ; “living donation” means a donation of organs, tissues and cells by a living person; “medical speciality” means a medical speciality recognised by the Medical Council under section 89 of the Act of 2007; “Minister” means the Minister for Health; “non-coronial post-mortem examination” has the meaning assigned to it by section 38 ; “organ” means a differentiated part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with a significant level of autonomy and a part of an organ shall be considered to be an organ if its function is to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation; “ Part 5 licence holder” has the meaning assigned to it by section 84 ; “parent” means— (a) in relation to a child, subject to paragraph (b), the father or mother (within the meaning of section 2 of the Guardianship of Infants Act 1964 ) of the child, (b) in relation to a child who is a donor-conceived child, the parent or parents of that child under section 5 of the Children and Family Relationships Act 2015 , or (c) in relation to a child where one parent has the sole custody, charge or care of the child, that parent; “pathologist” means a registered medical practitioner who is qualified by virtue of his or her training and expertise to perform post-mortem examinations; “post-mortem activities” has the meaning assigned to it by section 42 ; “post-mortem consent” means the consent of a person to post-mortem activities in accordance with section 47 , 48 , 49 or 50 ; “prescribed” means prescribed by regulations made by the Minister; “preservation” means— (a) in relation to an organ, the use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of the organ from procurement to transplantation, and (b) in relation to tissues or cells, the use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of the tissues or cells; “Register” has the meaning assigned to it by section 32 ; “register of medical practitioners” has the same meaning as it has in the Act of 2007; “registered medical practitioner” means a person who is a registered medical practitioner within the meaning of section 2 of the Act of 2007; “Regulations of 2006” means the European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006 ( S.I. No. 158 of 2006 ); “Regulations of 2012” means the European Union (Quality and Safety of Human Organs intended for Transplantation) Regulations 2012 ( S.I. No. 325 of 2012 ); “Specialist Division” has the same meaning as it has in the Act of 2007; “tissue” means all constituent parts of the human body formed by cells; “transplantation” means a process intended to restore certain functions of the human body by transferring an organ from a donor to the recipient of the organ; “writing” includes electronic communication, voice and video recording and speech recognition technologies. Regulations 3. (1) The Minister may by regulations provide for any matter referred to in this Act as prescribed or to be prescribed. (2) Without prejudice to any provision of this Act, regulations under this section may contain such incidental, supplementary and consequential provisions as appear to the Minister to be necessary or expedient for the purposes of the regulations. (3) Every regulation made by the Minister under this Act shall be laid before each House of the Oireachtas as soon as may be after it is made and, if a resolution annulling the regulation is passed by either such House within the next 21 days on which that House sits after the regulation is laid before it, the regulation shall be annulled accordingly, but without prejudice to the validity of anything previously done thereunder. Expenses 4. The expenses incurred by the Minister in the administration of this Act shall, to such extent as may be sanctioned by the Minister for Public Expenditure, National Development Plan Delivery and Reform, be paid out of moneys provided by the Oireachtas. Service of documents 5. (1) A notice or other document that is required to be served on or given to a person under this Act shall be addressed to the person concerned by name, and may be so served on or given to the person in one of the following ways: (a) by delivering it to the person; (b) by leaving it at the address at which the person ordinarily resides or, in a case in which an address for service has been furnished, at that address; (c) by sending it by post in a prepaid registered letter to the address at which the person ordinarily resides or, in a case in which an address for service has been furnished, to that address; (d) by sending it by means of electronic mail to the email address of the person in a case where the person giving the notice reasonably believes that the email address is being used by the first-mentioned person. (2) For the purpose of this section, a company formed and registered under the Companies Act 2014 or an existing company within the meaning of that Act shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body of persons shall be deemed to be ordinarily resident at its principal office or place of business. Guidelines 6. (1) The Minister may, after consultation with— (a) in the case of Part 2 , that part of the Executive known as the office for Organ Donation and Transplant Ireland, and the Authority, (b) in the case of Part 3 , the Health Information and Quality Authority, (c) in the case of Parts 4 and 5 , the Medical Council, and (d) such other persons as he or she considers appropriate, prepare and issue guidelines for the purpose of providing practical guidance as regards the operation of, and compliance with, this Act and any regulations made under it. (2) The Minister shall publish guidelines prepared and issued under this section. Designated family member in relation to relevant person 7. (1) (a) This section shall apply to— (i) the seeking and obtaining of appropriate consent or where deemed consent applies, seeking confirmation that there is no objection to a proposed transplantation of organs of a relevant person in accordance with Part 2 , (ii) the seeking and obtaining of appropriate consent in relation to a proposed removal of tissue and cells from a relevant person in accordance with Part 2 , and (iii) the seeking and obtaining of post-mortem consent in relation to any proposed post-mortem activity in respect of a relevant person in accordance with Part 3 . (b) Subject to this section, when a registered medical practitioner or suitably qualified person under the direction of a registered medical practitioner is— (i) seeking and obtaining appropriate consent or, where deemed consent applies, seeking confirmation that there is no objection to a proposed transplantation of organs of a relevant person in accordance with Part 2 , (ii) seeking and obtaining appropriate consent in relation to a proposed removal of tissues and cells from a relevant person in accordance with Part 2 , or (iii) seeking and obtaining of post-mortem consent in relation to any proposed post-mortem activity in respect of a relevant person in accordance with Part 3 , he or she shall seek such consent or confirmation from a designated family member. (2) In this Act, a “designated family member” means a person, who is, or was immediately before the death of the relevant person— (a) a spouse or civil partner of the relevant person, (b) a cohabitant of the relevant person, (c) a child of the relevant person, (d) a parent of the relevant person or a person who was a guardian of the relevant person before that relevant person attained 18 years, (e) a brother or sister (whether of the whole or half blood) of the relevant person, (f) a grandparent of the relevant person, (g) a grandchild of the relevant person, (h) an uncle or aunt (whether of the whole or half blood) of the relevant person, (i) a niece or nephew of the relevant person, or (j) a close friend of the relevant person who can demonstrate to the satisfaction of the person seeking consent or confirmation, as the case may be, that he or she can determine and accurately convey the wishes of the relevant person concerned. (3) Where in relation to a relevant person, a person referred to in subsection (2) is a person— (a) to whom a deed of separation or a decree of judicial separation is granted in relation to the relevant person, (b) who has entered into a written agreement to separate with the relevant person, (c) who has separated and ceased to cohabit with the relevant person for a continuous period of at least 12 months, (d) who does not have the capacity to consent, or (e) who immediately before the death of the relevant person, had not yet attained the age of 18 years (other than where he or she is the parent of that relevant person), that person shall be disregarded for the purpose of subsection (1). (4) Appropriate consent, including post-mortem consent, as appropriate, or, in the case of deemed consent, confirmation that there is no objection to deemed consent may be obtained from any designated family member with whom the registered medical practitioner has had real and substantial contact in relation to the care and treatment of the relevant person. (5) Where subsection (4) does not apply, appropriate consent, including post-mortem consent, as appropriate, or confirmation that there is no objection to deemed consent shall be obtained from a person whose relationship to the relevant person is accorded the highest ranking in accordance with subsection (2). (6) Where more than one person falls within a paragraph in subsection (2)— (a) each person within that paragraph shall be ranked equally, and (b) consent or confirmation that there is no objection to deemed consent may be obtained from any of the persons referred to within that paragraph. (7) In a case where persons of equal rank referred to in subsection (6)(a) are not in agreement and are unable to reach agreement in relation to consent or in the case of deemed consent confirm that there is no objection, the registered medical practitioner or, a suitably qualified person on behalf of the registered medical practitioner who is seeking such consent or confirmation in accordance with subsection (1) shall ask the persons concerned to reach a consensus agreement. (8) Where there is no appropriate consent, including post-mortem consent, as appropriate, or, in the case of deemed consent, no confirmation of no objection to deemed consent (by way of consensus reached under subsection (7) or otherwise), as the case may be, the proposed transplantation or non-coronial post-mortem examination concerned shall not, subject to section 51 , proceed. (9) For the purposes of subsection (1), a person who is not otherwise to be disregarded under subsection (3), shall not be included as a designated person under subsection (2) if— (a) the person does not wish to consider whether or not he or she objects or consents, (b) the person is unable to make a decision whether or not to object or consent, (c) the person is unable to confirm that there is no objection to deemed consent, (d) having regard to the proposed transplantation or non-coronial post-mortem examination in relation to which consent is sought, it is not reasonably practicable to communicate with the person in the time available if consent in relation to the transplantation or examination is to be acted on, or (e) the relationship between the person and the relevant person cannot be confirmed for the purpose of this section. (10) Where a designated family member is considering whether to provide appropriate consent, including post-mortem consent, as appropriate, consent or, in the case of deemed consent, confirmation of no objection, the family member shall consider and give substantial weight as to whether or not he or she believes that the relevant person, the subject of the request, would have had an objection to such donation, removal or non-coronial post-mortem examination. (11) Without prejudice to the generality of section 6 , the Minister shall issue guidelines in relation to the operation of this section, which guidelines shall include and make provision for the standard of contact appropriate to establish real and substantial contact for the purposes of subsection (4). (12) In this section— “decree of judicial separation” means— (a) a decree under section 3 of the Judicial Separation and Family Law Reform Act 1989 , or (b) a decree or order (howsoever described) of like effect to the decree referred to in paragraph (a) granted under the law of a place other than the State and recognised under the law of the State; “relevant person”, means the deceased person in relation to whom— (a) appropriate consent for proposed transplantation activities or confirmation that there is no objection to deemed consent under Part 2 is sought, or (b) post-mortem consent for a non-coronial post-mortem examination in accordance with Part 3 is sought. Provisions for storage, handling, transportation, and respectful disposal or return of bodies, anatomical specimens, organs or tissue 8. (1) Subject to this section, the storage, handling, transportation, disposal and return of an organ, tissue, body, body parts or an anatomical specimen may be undertaken where such storage, handling, transportation, disposal or return— (a) is undertaken in connection with any act done in accordance with Part 2 , 3 , 4 or 5 of this Act, as the case may be, and (b) has been subject to the consent as appropriate under the Part to which the organ, tissue, body, body parts or anatomical specimen relates. (2) Any storage, handling, transportation, disposal or return of an organ, tissue, body, body parts or anatomical specimen undertaken in relation to a deceased person shall have due regard to the dignity, bodily integrity and privacy of the deceased person. (3) Storage, handling, transportation, disposal or return of an organ, tissue, body, body part or anatomical specimen undertaken shall be recorded in writing by the hospital, licensed institution or Part 5 licence holder, as the case may be so as to ensure traceability. (4) A reference in this Act to the storage, handling, transportation, disposal and return of an organ, tissue, body, body part or anatomical specimen shall not include a reference to— (a) any activity which is related to arrangements regarding a funeral, burial or cremation of a body, (b) blood and blood components intended for transfusion in accordance with the European Communities (Quality and Safety of Human Blood and Blood Components) Regulations 2005 ( S.I. No. 360 of 2005 ), or (c) storage, handling, transportation and return, where applicable, of— (i) organs for transplantation, in accordance with the Regulations of 2012, and (ii) tissues and cells intended for human application, in accordance with the Regulations of 2006. (5) Nothing in this section shall operate to affect the law in relation to the duties of executors or administrators of a deceased person’s estate in so far as such duties concern the disposal of the body of the deceased person. (6) A person who is in lawful possession of an anatomical specimen under Part 5 or organs or tissues of a deceased person shall be responsible for the disposal or return of the anatomical specimen, or organs or tissues or their return to the designated family member, subject to the wishes of the designated family member. PART 2 Transplantation Chapter 1 Preliminary and general (Part 2) Interpretation and application 9. (1) In this Part— “blood” means whole human blood collected from a donor and processed for transfusion or further manufacturing; “blood component” means a therapeutic constituent of blood, namely red cells, white cells, platelets and plasma, that can be prepared by various methods; “broker” means a person or entity that facilitates or offers to facilitate the transaction of a potential organ donation for financial compensation or other non-financial inducements; “domino organ transplantation operation” means a transplantation operation performed on a living person by a registered medical practitioner which is designed to safeguard or promote the physical health of the person by transplanting an organ into that person and, by so doing, necessitating the removal of an organ from that person which, in turn, is intended to be used for transplantation in respect of another living person; “identified recipient” means in relation to a proposed transplantation activity, the person identified by the transplantation centre as being the person who will benefit from the proposed transplantation activity and who is generally known to the donor; “importing tissue establishment” means a tissue bank or a unit of a hospital or another body established within the State which is a party to a contractual agreement with a third country supplier for the import into the European Union of tissues and cells coming from a third country intended for human application; “non-directed altruistic donation” means the donation from an adult living donor who wishes to donate an organ for transplantation to a person neither named nor specified by that donor; “non-directed altruistic donor” means an adult living donor who wishes to donate an organ for transplantation to a person neither named nor otherwise specified by that donor; “organ donor” means a person who donates one or several organs, whether the donation of that organ or those several organs occurs during the lifetime or after the death of the donor; “Panel” has the meaning assigned to it by section 27 ; “processing” means all operations involved in the preparation, manipulation, preservation, and packaging of tissues and cells intended for human applications; “procurement” means— (a) in relation to an organ, a process by which the donated organ becomes available, and (b) in relation to tissues and cells, a process by which tissues and cells are made available; “procurement organisation” means— (a) in relation to the procurement of human organs, a healthcare establishment, a team or a unit of a hospital, a person, or any other body which undertakes or coordinates the procurement of organs, and is authorised to do so by the Authority in accordance with the Regulations of 2012, and (b) in relation to the procurement of tissues and cells, a healthcare establishment, a team or a unit of a hospital, a person, or any other body which undertakes or coordinates the procurement of tissues and cells, and is authorised to do so by the Authority in accordance with the Regulations of 2006; “psychiatrist” means a medical practitioner who is for the time being registered in the Specialist Division of the register of medical practitioners under the medical specialty of “Psychiatry” or under the medical specialty of “Child and Adolescent Psychiatry”; “regenerative tissue and cells” means tissue and cells which have regenerative properties and can be placed in the body of a living person, if the original tissue and cells in the body of the living person are injured or removed, in order to replace the original tissue and cells; “Register” shall be construed in accordance with section 32 ; “relevant organ” means a liver, lung, pancreas, heart or kidney; “relevant professional” means— (a) in relation to organ transplantation— (i) a registered medical practitioner, or (ii) a suitably qualified person acting on behalf of the registered medical practitioner, and (b) in relation to tissue and cells for human application— (i) a registered medical practitioner, (ii) a suitably qualified person acting on behalf of the registered medical practitioner, or (iii) a person referred to in Regulation 9(4)(a) of the Regulations of 2006; “specified person” has the meaning assigned to it by section 25 (4); “storage” means, in relation to tissues and cells, maintaining the tissues and cells under appropriate controlled conditions until distribution; “sufficient information” means, in relation to the seeking of consent by a relevant professional from a person, or the designated family member, or in the case of deemed consent, confirmation from the designated family member that there is no objection to transplantation activities— (a) clear information sufficient to enable the person concerned to understand the transplantation activities that are proposed to be carried out including information regarding the following: (i) the purpose and nature of the procurement, its consequences and risks; (ii) any analytical tests that may be performed; (iii) the recording and protection of donor data; (iv) medical confidentiality; (v) the therapeutic purpose and potential benefits of the proposed activities to which the consent relates; (vi) the applicable safeguards intended to protect the donor (including confidentiality), and (b) any information that it would be reasonable, on the request of the donor or designated family member, for the relevant professional to provide to that person in relation to the transplantation activities before or after such activities take place; “third country supplier” means a tissue establishment or another body, established in a third country, which is responsible for the export to the European Union of tissues and cells it supplies to an importing tissue establishment, which supplier may also carry out one or more of the activities, which take place outside of the European Union, of donation, procurement, testing, processing, preservation, storage or distribution of tissues and cells imported into the European Union; “tissue donor” means a human source, whether living or deceased, of human tissue of cells; “tissue establishment” means a tissue bank or a unit of a hospital or another body where activities of donation, procurement, testing, processing, preservation, storage or distribution of human tissues and cells are undertaken; “tissue recipient” means a person who receives tissues and cells for transplantation into his or her own body tissue from either— (a) his or her own body, or (b) the body of another person; “transplantation activities” shall be construed in accordance with section 11 ; “transplantation centre” means a healthcare establishment, a team or a unit of a hospital or any other body which is authorised under the Regulations of 2012 to undertake the transplantation of organs in accordance with those Regulations. (2) References in this Part to— (a) “removal”, in relation to removal of organs from a body for the purposes of transplantation or removal of tissues and cells from a body for the purposes of human application, does not include— (i) the removal of blood or blood components from a body, or (ii) the removal of tissues and cells to be used as an autologous graft within the same surgical procedure, and (b) “tissues and cells” does not include— (i) an organ, or (ii) any reproductive cells, within the meaning of the Regulations of 2006, taken for the purposes of the provision of assisted human reproduction in accordance with those Regulations. Deemed consent and appropriate consent – general provisions 10. (1) For the purposes of this Part, where deemed consent applies in respect of a deceased adult in accordance with section 18 and there is no objection to transplantation activities by the designated family member— (a) the designated family member shall confirm in writing, in the presence of a witness who shall attest the designated family member’s confirmation, that he or she has no objection to such transplantation activities, or (b) in a case where the family member concerned cannot provide confirmation in writing for any reason, that confirmation may be given orally by the person in the presence of two witnesses each of whom shall attest that the person has no objection. (2) (a) For the purposes of this Part, “appropriate consent” means consent provided without duress or coercion— (i) in relation to a deceased adult who is not registered on the Register and in respect of whom deemed consent does not apply, by the designated family member in accordance with section 19 , (ii) in relation to a deceased child, by a parent or guardian in accordance with section 21 , (iii) in relation to the donation of an organ by a living adult donor or a non directed altruistic donor, by the donor and, in the case of a non-directed altruistic donor, with the approval of the Panel in accordance with section 29 , (iv) in relation to the donation of tissues and cells by a living adult donor, by the donor, (v) in relation to the donation of regenerative tissues and cells by a living child, by a parent or guardian, with the approval of a Panel in accordance with section 31 , (vi) in relation to the donation of regenerative tissues and cells by a living adult who lacks capacity, by the specified person concerned in accordance with section 25 , with the approval of the Panel in accordance with section 30 , (vii) in relation to a case to which section 25 (2) applies, by the specified person concerned, or (viii) in relation to a case to which section 26 (2) applies, by a parent or guardian of the child. (b) For the purposes of this Part— (i) appropriate consent shall be in writing and shall be signed by the person giving the consent in the presence of a witness who shall attest the person’s signature, or (ii) in a case where the person cannot provide appropriate consent in writing that consent may be given orally by the person in the presence of two witnesses each of whom shall attest that the person gave consent. (3) A copy of a confirmation referred to in subsection (1) or a copy of an appropriate consent referred to in subparagraphs (i) to (viii) of subsection (2)(a) shall be— (a) retained with the medical records of the donor for a period of 30 years, and (b) offered to the person providing confirmation or consent and, on his or her request, shall be given to that person. (4) Prior to any importation of an organ into the State for the purpose of transplantation activities, a transplantation centre shall satisfy itself that— (a) the consent required for such transplantation activities has been obtained by the appropriate person in the country of origin where procurement of the organ took place, and (b) the procurement of the organ meets the legal requirements of the country of origin in relation to the transplantation activities concerned. (5) Prior to any importation of any tissues and cells into the State for the purpose of transplantation activities, a tissue establishment or an importing tissue establishment shall satisfy itself that— (a) the consent required for such transplantation activities has been obtained by the appropriate person in the country of origin where procurement of the tissues and cells took place, and (b) the procurement of the tissues and cells meets the legal requirements of the country of origin in relation to the transplantation activities concerned. (6) A person who contravenes— (a) subsection (3), (b) subsection (4), or (c) subsection (5), shall be guilty of an offence. (7) In this section, “country of origin” means the country from which the organ or tissues and cells, as the case may be, was or were procured before being imported into the State. Transplantation activities 11. (1) A person shall not carry out a transplantation activity unless he or she is satisfied— (a) where deemed consent applies and there is no objection to transplantation activities by the designated family member, that the family member has provided confirmation that he or she has no objection to such activities in accordance with section 10 (1), or (b) that the appropriate consent has been provided. (2) For the purposes of this Part, transplantation activities means any or all of the following: (a) the removal of an organ from the body of a living or deceased person for the purposes of transplantation; (b) the removal of tissues and cells from the body of a living or deceased person for the purposes of human application; (c) the use of any organs or tissues and cells removed from the body of a living or deceased person for the purposes of transplantation under paragraph (a) or human application under paragraph (b). (3) A person who contravenes subsection (1) shall be guilty of an offence. Principles governing organ and tissue and cell donation 12. (1) Subject to subsection (3), any donation of an organ or tissues and cells from a deceased or living donor shall be voluntary and unpaid and any financial compensation or other like reward given in respect of a donation of an organ or tissues and cells shall render any consent provided null and void. (2) A person shall not act as a broker or advertise the need for, or availability of, an organ or tissues and cells in respect of potential donation of such organ or tissues and cells for the purpose of offering or seeking any financial compensation or other non financial inducements. (3) A living donor may, subject to any regulations under subsection (4), receive financial compensation in relation to the donation of an organ or tissues and cells, provided such compensation is strictly limited to making good the reasonable expenses related to the donation. (4) The Minister may prescribe by regulations the conditions under which compensation may be granted in accordance with subsection (3), and such conditions shall ensure that there is no financial incentive or benefit to the donor in relation to the donation of an organ or tissues and cells. (5) Notwithstanding the generality of subsection (4), regulations under that subsection may specify an upper limit in respect of the total amount of compensation payable to a living donor, and an upper limit payable in respect of any of the matters specified in paragraphs (a) to (e) of subsection (10). (6) Before making regulations under subsection (4), 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; (c) a transplantation centre; (d) a tissue establishment; (e) any relevant patient advocacy group. (7) Subject to subsection (8), the procurement of any organ or tissues and cells by a procurement organisation, tissue establishment or importing tissue establishment shall be carried out on a non-profit basis. (8) Nothing in subsection (7) shall be construed as prohibiting a procurement organisation, a tissue establishment or importing tissue establishment from charging reasonable fees to cover the costs of procuring, retrieving, storing, testing or distributing human organs or tissues and cells. (9) A person who contravenes subsection (2) shall be guilty of an offence. (10) In this section, “reasonable expenses” means, in relation to a living donor, the amount required to compensate a donor for— (a) travel costs, (b) accommodation costs, (c) childcare costs, (d) medical expenses (including the costs of medical certificates), and (e) loss of income, reasonably incurred by him or her in relation to the provision of the organ or tissue and cells, as the case may be, calculated in accordance with regulations under subsection (4). Priority of organ donation 13. Subject to the Coroners Acts 1962 to 2024, the procurement of a person’s organs for transplantation shall have priority in relation to any consent provided— (a) for a non-coronial post-mortem examination in accordance with Part 3 , (b) by a person to donate his or her body for anatomical examination in accordance with Part 4 , or (c) by a person to donate his or her body for public display in accordance with Part 5 . Removal of tissue sample to determine viability of transplantation 14. Where it appears to a relevant professional removing, in accordance with the appropriate consent, (or, where deemed consent applies, in accordance with confirmation that there is no objection) an organ for transplantation or tissues and cells for human application from a deceased person, that it is necessary or expedient to remove and examine a tissue sample from any part of the donor’s body to determine the viability of the proposed transplantation activities (having regard, in particular, to the safety of the recipient), the person carrying out the removal may remove and examine such tissue sample as he or she considers necessary or expedient for such purposes. Preservation for transplantation activities – deceased persons 15. (1) Notwithstanding the generality of section 11 and subject to subsection (3), where an organ or tissues and cells, or both organs and tissues and cells, as the case may be, from a deceased person are, or may be, suitable for procurement for transplantation activities, a relevant professional may— (a) take such steps as are reasonably necessary for the purpose of maintaining such organs or tissues and cells for procurement for transplantation activities, and (b) in relation to a designated family member— (i) where deemed consent applies, seek confirmation that the designated family member has no objection to the procurement for transplantation activities on the deceased person, or (ii) where deemed consent does not apply, seek appropriate consent from the designated family member to the procurement for transplantation activities on the deceased person in accordance with section 10 , and the body of that deceased person may be maintained for that purpose. (2) The steps referred to in paragraph (a) of subsection (1) may be taken before, during or after the confirmation or consent referred to in paragraph (b) of that subsection has been obtained. (3) Where the designated family member objects to the procurement for transplantation activities on a deceased person, a relevant professional shall cease to take the steps referred to in subsection (1). Certification for transplantation activities – deceased donor 16. (1) This section shall apply only to a deceased donor from whom an organ is removed or tissues and cells are removed when he or she is no longer alive. (2) A person shall not remove an organ or tissues and cells from another person (in this section referred to as the “relevant donor”) for the purposes of transplantation activities unless— (a) following a medical examination by a registered medical practitioner, he or she is satisfied that the relevant donor is no longer alive, and (b) the confirmation or appropriate consent under section 10 (1) and (2) is in place. (3) In so far as it is clinically appropriate, a registered medical practitioner referred to in subsection (2) who certifies the death of the relevant donor shall not— (a) have a primary role in relation to the removal of an organ or tissues and cells from the relevant donor, (b) have a primary role in relation to transplantation activities in respect of the relevant donor or recipient, or (c) have primary responsibility for the medical treatment of the potential recipients of the organ or tissues and cells the subject of the transplantation activities. (4) A person who knows, or has reason to believe, that an examination of a body is, or may be, required by a coroner in accordance with the Coroners Acts 1962 to 2024, shall not remove an organ or tissues and cells from that body for the purpose of transplantation activities (or authorise another person to remove an organ or tissues and cells for such purposes), unless and until the coroner has confirmed that examination of the body is not required to enable the coroner to perform his or her functions under those Acts. (5) A coroner may provide confirmation under subsection (4) orally and, where he or she does so, he or she shall also, as soon as practicable thereafter, provide such confirmation in writing including details of the date on which and time at which that he or she provided such confirmation. (6) A person who contravenes— (a) subsection (2), or (b) subsection (4), shall be guilty of an offence. Review of operation of Relevant Organ Donation Opt-Out Register 17. (1) The Minister shall, not later than 3 years after the commencement of this section, carry out a review of the operation of the Relevant Organ Donation Opt-Out Register. (2) In carrying out a review under subsection (1), the Minister may consult with such and so many persons as he or she considers appropriate. Chapter 2 Consent Deemed consent for donation of relevant organs and removal of relevant organs 18. (1) Subject to subsections (2) and (3), a person shall be deemed to consent to the donation, after his or her death, of his or her relevant organs (in this Act referred to as “deemed consent”) where he or she has not registered his or her objection to such organ donation on the Register in accordance with section 33 . (2) Subsection (1) shall not apply— (a) to a person who has not been ordinarily resident in the State for a period of at least 12 months immediately before the date of his or her death, (b) to a person who, for a significant period before his or her death, lacked the capacity to understand that his or her consent would be deemed to be such if he or she did not register an objection to the donation of his or her organs on the Register, (c) to a person in respect of whom a designated family member cannot be identified or confirmed, or (d) to a child. (3) Where a person has not registered his or her objection to the donation of his or her relevant organs in accordance with section 33 , a registered medical practitioner who, after the person’s death proposes to remove a relevant organ from that person for the purposes of transplantation shall satisfy himself or herself that the designated family member of the person has confirmed that he or she does not have any objection to the donation of the relevant organ. (4) A registered medical practitioner shall not remove a relevant organ from a person for the purposes of transplantation if he or she has not satisfied himself or herself in accordance with subsection (3). (5) Without prejudice to the generality of this section when seeking to satisfy him or herself as to whether there is any objection to the donation of a relevant organ to be used for transplantation, a relevant professional shall, in accordance with any guidelines and, where appropriate in accordance with the Regulations of 2012— (a) subject to Regulation 24(7) of the Regulations of 2012, provide the designated family member with sufficient information, and (b) inform the designated family member of the effect of subsection (9). (6) Where a designated family member is approached to confirm that there is no objection to the donation of relevant organs for the purpose of transplantation, the family member shall consider and give substantial weight as to whether or not he or she believes that the relevant person, the subject of the request, would have had an objection to such a procedure. (7) Where a designated family member objects to the donation of a relevant organ, the relevant organ shall not be used for transplantation and the objection of the designated family member shall be recorded in writing by the relevant professional and retained with the deceased person’s medical records for a period of 30 years. (8) Where the designated family member has confirmed that he or she has no objection to the removal and donation of a relevant organ, he or she shall provide confirmation that the relevant organ may be used for transplantation in accordance with section 10 (1). (9) A designated family member may, at any time up to the commencement of the process for removal of the relevant organ for transplantation, object to the donation but no objection can be made once the process for removal of such relevant organ has begun. Consent for organ donation given by designated family member where deemed consent does not apply 19. (1) This section applies to the donation of any organ from a deceased person where deemed consent does not apply in accordance with section 18 . (2) A registered medical practitioner shall not remove any organ from a deceased person for the purpose of transplantation without appropriate consent. (3) When seeking appropriate consent from the designated family member for the donation of an organ from a deceased person for the purpose of transplantation, a relevant professional shall, in accordance with the Regulations of 2012 and any guidelines— (a) subject to Regulation 24(7) of the Regulations of 2012, provide the designated family member with sufficient information, and (b) inform the designated family member of the effect of subsection (5). (4) Consent given by a person under this section is given only for the purposes of transplantation. (5) A designated family member may, at any time up to the commencement of the process for removal, withdraw consent referred to in subsection (2), but such consent cannot be withdrawn once the process of removal has begun. Consent for tissues and cells donation given by designated family member in respect of deceased adult donor 20. (1) This section applies to the donation of any tissues and cells from a deceased adult donor. (2) A relevant professional shall not remove any tissues and cells from a deceased person for the purpose of human application without the appropriate consent. (3) When seeking appropriate consent from the designated family member for the donation of tissues and cells to be used for human application, a relevant professional shall, in accordance with the Regulations of 2006 and any guidelines— (a) subject to Regulation 18(6) of the Regulations of 2006, provide the designated family member with sufficient information, and (b) inform the designated family member of the effect of subsection (4). (4) A designated family member may, at any time up to the commencement of the process for retrieval of the tissues and cells for human application, withdraw consent referred to in subsection (2) but any such consent cannot be withdrawn once the process of removal has begun. Consent by parent or guardian in respect of deceased child 21. (1) A registered medical practitioner shall not remove any organ for the purpose of transplantation from the body of a deceased child without the appropriate consent. (2) When seeking consent from a parent or guardian under subsection (1), a relevant professional shall, in accordance with the Regulations of 2012 and any guidelines— (a) subject to Regulation 24(7) of the Regulations of 2012, provide the parent or guardian concerned with sufficient information, and (b) inform the parent or guardian, as the case may be, of the effect of subsection (7). (3) A relevant professional shall not remove any tissues and cells for the purposes of human application from the body of a deceased child without the appropriate consent. (4) When seeking consent from a parent or guardian under subsection (3), a relevant professional shall, in accordance with the Regulations of 2006 and any guidelines— (a) subject to Regulation 18(6) of the Regulations of 2006, provide the parent or guardian concerned with sufficient information, and (b) inform the parent or guardian, as the case may be, of the effect of subsection (7). (5) (a) Where one of the parents or guardians of a deceased child has provided consent in accordance with subsection (1) or (3), as the case may be, (“the first p …