David Cullinane (Waterford, Sinn Fein)
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682. To ask the Minister for Health further to Parliamentary Question No. 2061 of 29 April 2025, the status of each piece of required supporting legislation, guidelines, and relevant codes of practice; when each piece will be prepared and in place; when the act will be commenced; in particular, when statutory guidelines will be in place for the management, retention, and disposal of human tissues; if she is concerned that the lack of statutory guidelines means that, despite having passed the legislation, the Government is failing to deliver on its commitments to parents of children whose organs were sent abroad for incineration or otherwise mishandled; and if she will make a statement on the matter. [27000/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024 was enacted in February 2024.

The Act 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. Crucially, it embeds in legislation the idea that consent is the defining principle across all these sensitive areas.

As the various Parts of the Act deal with somewhat discrete areas, I will be commencing the Act on a phased basis.

I have announced that Part 2 of the Act, which will provide, for the first time, a national legislative framework for donation and transplantation services, will commence on 17 June 2025.

Part 2 of the Act introduces deemed consent for organ donation meaning that when a person dies it is presumed that they would wish to donate their organs after their death unless they have recorded a decision not to donate on the Relevant Organ Donation Opt-Out Register or are in one of the excluded groups. It is important to reassure people that family members will always be consulted before any action is taken.

Part 2 also expands pathways for living and altruistic organ donations. These measures will help increase the donor pool in Ireland, while always fully respecting the wishes of people and their families.

Along with other arrangements to enable commencement of Part 2, I plan to introduce guidelines relating to the role of the designated family member and regulations to underpin the Living Donor Reimbursement Scheme.

Following the imminent commencement of Part 2, focus will move to commencement of Part 3, which deals with post-mortem practice and procedures, including the regulation of the retention, storage, use, disposal and return of organs and tissue from deceased persons.

Part 3 of the Act will introduce consent provisions for non-coronial post-mortems and sets out a clear framework for how consent should be obtained and the information that must be given to individuals or their families when seeking such consent. Consent will also be needed from families for arrangements relating to burial, cremation or the return of any organs retained from a post-mortem examination.

These measures are something that families impacted by recent controversies have called for, and it is important that the legislation addresses these requests.

Regulations will be prepared to provide for the management of material removed during a post-mortem examination that takes place in a hospital. These will apply to both non-coronial examinations and those directed by the coroner.

Separate regulations will be prepared under the amendments to the Coroners Act. These will largely mirror the Human Tissue Act regulations where appropriate and will apply to non-hospital sites that undertake post-mortem examinations.

These measures will, where possible and appropriate, ensure parity of regulation across services. The regulations will be prepared in a manner consistent with the relevant guidelines in the HSE National Clinical Guidelines for Post-Mortem Examination Services which were updated in 2023.

A range of guidelines are also required under Part 3, including for the management of material removed during post-mortems, consent for post-mortem activities, post-mortem reports.

Parallel to this work, the Department will seek to progress Parts 4 and 5, concerning anatomical examination and public display of bodies after death with the Medical Council. This will require the establishment of licencing and inspection regimes, along with relevant codes of practice.

Before full commencement, it will be necessary to ensure that all required supporting legislation, guidelines, and relevant codes of practice are in place.

Every effort is being made to ensure that commencement takes place in a timely manner, while ensuring that the legislation is set up for success by having the relevant prerequisites in place to enable it to be operated effectively.