A new lease of life for organ donation regulation - The Human Tissue Act becomes law

[1] Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024From 17 June 2025, the initial stage of the phased commencement of the Human Tissue Act brings with it an entirely new landscape for organ donation in Ireland. This significant piece of legislation has profound implications for individuals and healthcare providers.

The first phase primarily addresses organ, tissue and cell donation and transplantation, and in doing so, fundamentally alters the consent model for the benefit of those in need of potentially life-saving transplants.

Key provisions

1. “Opt-out” system 

The concept of “deemed consent” is introduced under the new system.[2] The Act provides that a person who dies shall be deemed to consent to the donation of their relevant organs where they have not registered an objection to such donation. The concept of “relevant organs” refers to the liver, lung, pancreas, heart or kidney.

Those who wish to maintain the status quo in terms of the potential medical use of their organs on their death now need to take active steps to do so. A new “opt-out” register, to be managed by the HSE, came into effect on Tuesday.  An objection on the Register remains there for the lifetime of that person if it is not withdrawn. The details of the Register will not be made public.

For all other organs, tissues, or cells, consent will be sought from a family member – as was previously the case.

 Crucially, the “opt-out” system will not apply in the following circumstances: -

1. Where the deceased was not ordinarily resident in Ireland for twelve months prior to death;
2. Where the deceased lacked the capacity to understand “deemed consent” in the absence of an objection;
3. Where a designated family member cannot be identified or confirmed;
4. Where the deceased is a child.

2. Final consent of the designated family member 

The Act maintains the pre-existing safeguard in the law on organ donation in requiring a medical practitioner, where a person has not registered an objection, to satisfy themselves that the designated family member of the person has confirmed that he or she does not have any objection to the donation of the relevant organ.[3]

A designated family member is defined as a spouse, cohabitant, close friend or other close family member as listed in the act.

This provision underscores the importance of communicating one’s wishes during one’s lifetime; particularly now where one might believe they have done all they need to do by not opting out.

3. New pathway for living donation

A living person who donates an organ to someone they do not know is considered a non-directed altruistic donor. Previously, there was no means to do so in Ireland and individuals travelled north or overseas.

The Act now provides specific conditions which will allow a medical practitioner to remove an organ for such purposes.[4] These conditions cover issues such as consent, the purpose of the transfer and compensation for the organ – which is explicitly forbidden, be it financial compensation or otherwise.

Under the Act, an Independent Panel will be established which will consider, among other types of donations, applications for non-directed altruistic donations.

Conclusion

Enacted in February 2024, this week marked the first phase of commencement of the Human Tissue Act, and is a welcome development for those who are willing to be a donor but who may not have taken the necessary steps of their own accord, those who might be lucky enough to benefit from such a donation, and those medical practitioners who now have some clarity on issues of consent as well as a framework for living donation.

It remains to be seen when the remaining provisions of the Act will be commenced. These provisions concern, among other things, post-mortem practices and procedures and anatomical examination. Alongside the awaited reforms to the Coroners Act, this is an area of law in flux. It is hoped that the reforms discussed herein and those to come can better manage the current demands in this sensitive and often emotional area of practice.

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

[2] ibid Chapter 2, Section 18.

[3] ibid Section 18 (3).

[4] ibid Section 24.