Organ Donation & Transplant

2024 Act

Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024  is divided into six Parts. Further details of the provisions included in each of these parts follows.

The Minister may issue guidelines for the purpose of providing guidance to clinicians and others regarding the operation of, and compliance with, the Act.

A “designated family member” is someone who has an established relationship with the deceased. They will be consulted regarding consent or confirmation of no objection for organ and tissue and cell donation or non-coronial post-mortem examination as appropriate within the provisions of the Act.

The Act sets out who will be considered a “designated family member”. It allows for consent/confirmation of no objection to be obtained from the family member who has been the main point of contact for clinicians in their treatment of the deceased. In instances where such a scenario does not apply, the designated family member will be determined via a hierarchy set out.

The Act  requires that when making their decision, the designated family member must give substantial weight to whether the deceased would have had an objection to the transplantation, removal or post-mortem examination in question.

The Act sets out conditions for the storage, handling, transportation, disposal and return of organs, tissue, bodies, body parts and anatomical specimens in accordance with the Act. Such activity should have due regard to the dignity, bodily integrity and privacy of the deceased person and mandates that written records be kept in respect of these activities to ensure traceability.

Transplantation

The concept of “deemed consent” is strictly for the purposes of the Part and applies specifically to donation of specific organs by a deceased adult where the individual has not registered an objection to becoming an organ donor on the Organ Donation Opt-Out Register. It also defines “appropriate consent” for the purposes of this Part and describes the scenarios where appropriate consent should be sought. The process for recording consent or no objection in the case of deemed consent is also set out0.

The 2024 Act defines the term “transplantation activities” and outlines the conditions under which transplantation activities may take place. Carrying out transplantation activities outside of these conditions is an offence under the Act.

The principles of organ and tissue and cell donation are set out. These include that donation must be voluntary and unpaid, and it makes it an offence to seek or offer financial or non-financial rewards by advertising the need for or availability of organs or tissues and cells. It allows for a living donor to receive expenses for loss of income and costs connected to the donation and sets out the conditions for this. The Minister for Health is given the authority to make regulations in respect of compensation under this section.

Priority of Organ Donation

Consent to organ donation for transplantation will have priority over consent for any other purpose, including post- mortem examination (Part 3), donation for anatomical examination (Part 4), or public display (Part 5). This is subject to the Coroners Acts 1962 to 2020 and does not apply if the body comes under the jurisdiction of the coroner.

A clinician may remove a tissue sample from a proposed donor to determine the viability of transplantation if it is considered necessary or expedient and in circumstances where consent for donation has been secured. Clinicians may  take steps to preserve organs or tissues and cells that may be suitable for transplantation while consent or confirmation of no objection to donation is being sought. This ceases to apply if it is established that a designated family member objects to the donation.

There are specific steps which must be followed ahead of transplantation activities taking place in instances involving a deceased donor. These include ensuring that the relevant consent or confirmation of no objection is in place and that the Coroner has signed off on organ or tissue and cell retrieval in instances of death that fall under the jurisdiction of the Coroner’s Acts. Failure to comply with either of these two measures is an offence under the Act.

Consent

There are conditions where deemed consent applies and the process to be followed by clinicians in instances of deemed consent. There are  exemptions for deemed consent. The  wishes of the deceased must be considered by the designated family member when deciding whether to object to organ donation. There is a point up to which consent can be amended or withdrawn.

There are conditions for organ donation where deemed consent does not apply and where consent must be sought from a designated family member. It prohibits clinicians from removing an organ from a deceased person unless they are satisfied that consent is in place. There are provisions for the donation of tissue and cells from deceased donors and the conditions for obtaining consent to such donation.

There are  conditions which must be met and the steps that must be followed for organ and tissue and cell donation in respect of a deceased child under the age of 18.

Donation Conditions

There are conditions which must be met for the donation of organs by living adult donors, including the information that must be provided and the principles that must be adhered to for such donation. It also identifies the point up to which consent can be amended or withdrawn.

There are conditions which must be met for the donation of tissues and cells by living adult donors including the information that must be provided and the principles that must be adhered to for such donation. It also identifies the point up to which consent can be amended or withdrawn.

There are conditions that must be met before a person can donate an organ to a person who is not known to them (also known as “altruistic donation”). Altruistic donors donate to the transplant pool rather than directing their donation to a specific person. There is information that must be provided to donors and the principles that must be adhered to for such donation. Approval for such donation must be given by the independent panel.

There are conditions in relation to donation of organs and tissues and cells by living adults who lack capacity and conditions that must be met and steps that must be followed before the donation of tissues and cells by living adults who lack capacity can take place. It prohibits living organ donation by adults who lack capacity, unless that organ must be removed as part of a domino transplant operation. It also sets out the process for obtaining consent in such a scenario. The donation of tissues and cells by living adults who lack capacity must be approved by the independent panel established.

There are conditions that must be met and steps that must be followed before the donation of tissues and cells by living children. It also prohibits living organ donation by children unless that organ must be removed as part of a domino transplant operation. Consent for living donation by a child of tissues and cells must be sought from a parent/ guardian of the child and approval for the donation must be given by the independent panel established.

Independent Panel

The Minister for Health shall  establish an independent panel to authorise living donation of organs and tissues in certain scenarios which require additional safeguards to protect the potential donor. The panel consists of 8 members. There are specific competencies for certain panel members.

There is a process by which an application is made to the panel for approval for non-directed altruistic donation and the steps that the panel must take when considering such an application.

There is a  process by which an application is made to the panel for approval for donation of tissue and cells by adults who lack capacity. It stipulates the conditions under which such a donation can take place and outlines the steps that the panel must take when considering such an application.

An application is made to the panel for approval for donation of tissue and cells by living children. The Act stipulates the conditions under which such a donation can take place and outlines the steps that the panel must take when considering such an application.

Relevant Organ Donation Opt-out Register

An Organ Donation Opt-Out Register is  established and maintained by the Health Service Executive (HSE). All adults have the option to register their objection to becoming an organ donor after death i.e., to “opt-out” of organ donation. The register will be securely maintained and will not be accessible to the public.

The 2024 Act sets out the process to be followed by an individual who wishes to be included on the Organ Donation Opt-Out Register. It details the information that an applicant shall provide as part of his or her registration. It allows for an individual to amend or withdraw their registration and prohibits individuals from registering or amending the details of others on the Register without prior consent from the person concerned.

A clinician shall apply to the HSE to seek confirmation of whether a person is listed on the Register in cases where donation is being considered. It also details the steps that should be taken once they have received such information.

The Health Products Regulatory Authority (HPRA) the necessary powers to serve as regulator of Part 2 of the Act. Any functions relating to the Panel, or the Opt-Out Register are excluded.