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

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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: