Human Tissue Act 2024: A New Era for Organ Donation in Ireland

Part 2 of the Human Tissue Act 2024 (the “Act”) will commence tomorrow, transforming the process of organ donation in Ireland. In this article, Clíona O’Brien, Solicitor explores how the new legislation creates an automatic preference in favour of organ donation, which replaces the current voluntary “opt-in” model. The new soft opt-out system allows preferences to be recorded for individuals who do not wish to engage in organ donation, with the establishment of a national opt-out register.

Currently, over 600 people are waiting for transplants in Ireland, and it is hoped that this new law will act as a vital step for many patients and their families.

Organ Donation: Pre June 17 2025

Until now, organ donation in Ireland was regulated in accordance with the HSE National Consent Policy on Organ Donation and had no statutory framework. Ireland operated a voluntary “opt in” model which relied on individuals proactively making their donation wishes known either through informal discussions with family, or by registering with an organ donor card or noting it on their driving licence. This often led to uncertainty and comparatively low organ donation rates, partly due to lack of clarity on individuals wishes and the emotional and complex decision-making for families at a time of grief.

Organ Donation: Post 17 June 2025

Under the new  “soft opt-out” model of consent:

• All adults aged 18 or over, ordinarily resident in Ireland, are deemed to have consented to organ and tissue donation after death, unless they have opted out.
•  Families will continue to be consulted, and if there is clear evidence that the deceased would not have wished for donation to take place, donation will not proceed.
• Where deemed consent does not apply, or in cases involving living donors, explicit consent is required from the individual or their legal representative. This must be given voluntarily, without coercion, documented in writing or, where this is not possible, orally in the presence of witnesses.

Consent Requirements for Living Donors

For living individuals, the Act outlines specific consent procedures:

• Adults with Capacity: Must provide written consent in the presence of a witness.
• Adults Lacking Capacity: Consent must be obtained from a legally designated representative, with additional approval from the Transplantation Advisory Panel.
• Children: Consent must be provided by a parent or guardian, with approval from the Panel for certain types of donations.

The National Opt-Out Register

The HSE will manage the Relevant Organ Donation Opt-Out Register (the “Register”) which will be the national confidential record of individuals who have chosen not to be considered organ donors.

Key features include:

• Registration is voluntary and reversible at any time.
• Only to authorised healthcare personnel can access it

Individuals will receive notification of their opt-out status and will be asked to  confirm this.

Review of the Opt-Out System

Section 17 of the Act mandates a periodic review of the Register to ensure it remains effective, responsive to public needs and ethical sound.

Consultation with Families

The voice of the family still remains central to the organ donation process in Ireland. Even where deemed consent applies healthcare professionals must consult the family before any organ retrieval. If the family provides credible information that the deceased would not have consented, the donation will not take place. This ensures that both individual autonomy and family perspectives are always respected.

The Transplantation Advisory Panel (the “Panel”)

A Panel will be appointed  by the Minister for Health whose  remit includes:

• Ethical Review: Assessing the ethical implications of proposed donations.
• Approval: Granting or withholding consent for specific donation cases.
• Guidance: Providing advice on best practices and standards.

The Panel acts as a safeguard and ensures best practice across the donation and transplantation system particularly in complex situations which may require additional assistance and support.

Clinical Standards and Organ Allocation

The legislation also sets out important clinical and ethical principles, including:

• Equity: Organ transplants must be allocated on medical need.
• Testing for viability: tissue samples may be removed before donation to determine organ suitability.
• Certainty of death: a medical practitioner must certify death before organ retrieval.

Promoting Awareness and Public Confidence

Recognising the importance of public understanding, the Act places responsibility on the HSE and Department of Health to lead nationwide education campaigns to inform individuals of their rights, including how to opt out and encourage open  conversations in relation to organ donation.

Conclusion

The Act brings Ireland in line with international best practice, while still providing a mechanism which preserves personal choice and individual autonomy.

Organ donation is often described as a final act of kindness, and it is hoped that this new legislative framework will assist in transforming the lives of many.