ieExplains: The organ donation system is changing. Here's what you need to know

The Human Tissue Act 2024 is a composite piece of legislation that includes provisions around 'donation and transplantation of organs, tissues, and cells, post-mortem practice and procedures, anatomical examination, and public display of bodies after death'. File picture

Under new legislation that comes into operation from Tuesday, everybody will now be considered an organ donor unless they choose to add their name to a consent opt-out register, or are among a so-called excluded group.

This is part of the Human Tissue Act 2024. 

Here, we explain the features of the Act in more detail:

What is the Human Tissue Act?

The Human Tissue Act 2024 is a composite piece of legislation that includes provisions around "donation and transplantation of organs, tissues, and cells, post-mortem practice and procedures, anatomical examination, and public display of bodies after death".

The Department of Health says the Act "embeds in legislation the idea that consent is the defining principle across all these sensitive areas".

The changes contained within the Act are being commenced on a phased basis, the department says, to ensure they are "brought into operation in a coherent manner".

So what exactly is in this first phase?

From today, Tuesday, June 17:

• A "soft opt-out system" of consent is in place for organ donation for people aged 18 and over;
• The concept of a “designated family member” will be formalised, and this person will be consulted prior to the donation of organs and tissues from deceased persons;
• And there will also be a new pathway introduced for people who wish to make a living donation of a kidney to someone they don’t personally know (also known as non-directed altruistic donation).
  Now, let's examine each of these three points.

What is the soft opt-out system and why does it matter?

According to Department of Health figures, there are, at any given time, approximately 600 people in Ireland on waiting lists for organ transplants. Each year, hundreds of people in Ireland have their lives transformed, and indeed, saved by organ donation.

From now on, in line with international best practice, those over the age of 18 will be considered to have agreed to be an organ donor upon their death, unless they have chosen to opt out or are in one of the excluded groups.

This change only applies to organs referred to as relevant under the legislation - liver, lung, pancreas, heart, and kidney. For all other organs and tissues, consent will be sought from a family member, as was the case before now.

From today, consent for organ donation is presumed, and therefore someone who wants to be an organ donor does not now need to take any action. Consent is presumed if a person has not opted out via the National OptOut Register for Organ Donation and does not fall under an exception.

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If someone does not want to be an organ donor, they can apply to the Relevant Organ Donation Opt-Out Register maintained by the HSE. Family members of people on this register will not be asked about organ donation.

The Department of Health says it is important for people to let their family members know of their wishes as regards organ donation so that these wishes can be honoured.

Anyone wishing to opt out can do so via www.hse.ie/organdonation or contact HSE Live on 1800 700 700.

On this point, the department noted that not everyone dies in circumstances that make organ donation possible.

"Medical criteria and other conditions must also be met. A potential donor has to be in a hospital and maintained on a life support machine (ventilator) before they can become an organ donor," a department spokesperson said.

"The Act does not change the medical criteria."

Excluded groups/Exceptions to deemed consent

The HSE says the opt-out register does not apply to:

• Children under the age of 18 – Parents and guardians may provide appropriate consent for organ donation on behalf of their child, where possible. This provision also applies to parents under the age of 18, recognising their right to make such an important decision for their child.
• Non-residents – Those who have lived in Ireland for less than one year.
• Lack of capacity – Adults who lacked capacity to understand deemed consent before their death.
• Uncontactable family – If family members cannot be reached in time, deemed consent cannot proceed.

The next of kin will always be asked for consent in these cases. If a person has opted out, organ donation will not proceed, and the family will not be approached.

Who is considered a designated family member?

According to the Department of Health, consent is a "cornerstone" of the Human Tissue Act 2024. The Act formalises the concept of a "designated family member". This is the person who will be consulted regarding consent or confirmation of no objection to donation.

The Act itself sets out who will be considered a “designated family member”, as well as some exceptions.

This step, the department says, allows for "consent or 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".

Where this doesn’t apply, the designated family member will be determined by the hierarchy in the Act - i.e spouse or civil partner, cohabitant, child, parent/guardian etc, all the way down to a close friend.

Detailed guidelines on the designated family member, and some exceptions are available here.

What is non-directed altruistic donation?

A non-directed altruistic donor is a living person who donates an organ to someone they do not know, and who is on a waiting list.

The new Act establishes a pathway for non-directed altruistic donation, by adults only with "additional protections and safeguards in place for those wishing to donate".

The Department of Health says that a new Independent Panel will be established to consider applications for non-directed altruistic donations going forward, as well as other types of donations.

"Further information will be available on this donation pathway once the panel is established," a spokesperson for the department said.

What about the next phases of the Act?

The Department of Health says that the other phases of the Act, which deal with post-mortem practice, anatomical examination, and public display of bodies after death, will follow "in due course".

A Department of Health spokesperson said all of 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".

Speaking on Tuesday, the minister for health Jennifer Carroll MacNeill said the Government, in commencing the second part of the Act, are hoping to "increase the donor pool in Ireland by making organ donation the norm, while always fully respecting the wishes of individuals and their families".

"I extend my gratitude to everyone who contributed to shaping and bringing these provisions to life," she said. "I encourage everyone to discuss their organ donation wishes with their families."