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

PART 1 Preliminary and General

1. 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.

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 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.