A New Lease Of Life For Organ Donation Regulation – The Human Tissue Act Becomes Law – Healthcare

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From 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.

Ireland
Food, Drugs, Healthcare, Life Sciences

From 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.¹ 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not withdrawn.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.²

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.³ 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.

Footnotes

1.ibid Chapter 2, Section
18.

2.ibid Section 18 (3).

3.ibid Section 24.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.