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

• Jurisdiction: Ireland
• Year: 2024
• Citation: IR No. 5/2024

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

2024 5

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

[28 February 2024]

Be it enacted by the Oireachtas as follows:

1 Short title, commencement and collective citation

(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.

2 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 bysection 10;

“Authority”, other than inPart 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 insection 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 withsection 18;

“designated family member” has the meaning assigned to it bysection 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 undersection 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 undersection 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 bysection 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 bysection 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 toparagraph (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 bysection 42;

“post-mortem consent” means the consent of a person to post-mortem activities in accordance withsection 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 bysection 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...