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

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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.