Minister for Health announces the commencement of Part 2 of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024

Minister for Health Jennifer Carroll MacNeill has today announced the commencement of Part 2 of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024, concerning donation and transplantation.

The provisions of the Act coming into operation today provide, for the first time, a national legislative framework for organ donation and transplant services in Ireland.

From today, Ireland will have a soft opt-out system of consent for organ donation. This means that consent for organ donation will be deemed unless the person has registered a wish not to become an organ donor after death.

Families will continue to be consulted as part of a safe and respectful organ donation process, and the wishes of the deceased should be central to any decision. Guidelines have been published to assist in understanding this process.

Pathways for living organ donations have been expanded to include non-directed altruistic donation allowing living donors to donate to the transplantation system rather than to a specific person. In addition, the Living Donor Reimbursement Scheme is being placed on a statutory footing for the first time.

These changes were subject to extensive consultation during the creation of the legislation and throughout the development of the necessary supporting legislation, guidelines, and other practical arrangements including the HSE’s Relevant Organ Donation Opt-Out Register.

Reflecting on the significance of this step, Minister Carroll MacNeill said:

For more information on the change please visit: www.gov.ie/organdonation

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

The Act has been drafted to provide:

• general conditions for the removal, donation and use of organs and tissue from deceased and living persons for transplantation
• regulations for both non-coronial and coronial post-mortem examinations in hospital and non-hospital settings
• general conditions and regulations for anatomical examination
• general conditions and regulations for public display of bodies after death

The Act introduces a new statutory requirement for consent across all of these activities as well as safeguards to protect the integrity of the human body before and after death and to prevent any organ retention without consent in the future.

The Act introduces, from 17 June, a soft opt-out system of consent for organ donation. Under this legislation, consent for organ donation will be deemed unless the person has, while alive, registered their wish not to become an organ donor after death. In other words, when the Act is commenced, a person’s willingness to donate their organs after their death will be assumed, unless they make a statement of objection to donation. Previously, decisions about organ donation were the responsibility of the next-of-kin.

Families will continue to be consulted as part of a safe and respectful organ donation process, while the wishes of the deceased should be central to any decision.

The Act further provides a framework for the donation of organs, tissues and cells from living donors and introduces a legislative basis for non-directed altruistic living donation i.e. donation by living donors to the transplant system, not a specific person, where donations can be assigned to patients identified by clinical staff.

It is anticipated that the commencement of Part 2 of the Act, concerning organ donation and transplantation, and the implementation of the consequent measures will help increase the donor pool in Ireland and will encourage organ donation to save lives in circumstances where this is possible.

Designated Family Member Guidelines

The Act introduces the concept of the designated family member i.e. the person who will be consulted regarding consent or confirmation of no objection to donation.

The Designated Family Member Guidelines outline the role of the “designated family member’ in the context of consent under Part 2 of the Act concerning donation and transplantation and the conditions which must be met.

The Guidelines are available at www.gov.ie/organdonation

Living Donor Reimbursement Scheme Regulations 2025

The Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) (Living Donor Reimbursement Scheme) Regulations 2025 have been introduced to place the Living Donor Reimbursement Scheme on a statutory footing.

To date, the Living Donor Reimbursement Scheme Policy has been operated on a non-statutory basis. The policy intends to minimise financial disincentives for potential living organ donors, with a view to ensuring the pool of living donors continued to expand. The policy is based on the premise that although reimbursement may be granted, such reimbursement cannot confer any financial reward on a potential donor.

Funding of €2 million for 2025

To support and maximise the outputs from progressing this Programme for Government commitment, the Minister for Health announced an additional €2 million of new development funding for services through Organ Donation and Transplant Ireland.

This funding will support and enhance organ donation and transplantation services, bolstering Ireland’s capacity for life saving organ transplants. More precisely, it will deliver:

• the development of the Organ Donation Transplant Ireland national structure;
• the expansion of the National Potential Donor Audit;
• increased staffing infrastructure for organ donation; and
• the development of the National Organ Retrieval Service

The goal is to:

• increase organ availability for transplantation;
• reduce the existing transplant waiting list of over 650 people; and
• promote organ donation through the implementation of the Human Tissue Act 2024