Minister for Health Stephen Donnelly has today secured government approval for the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill.
The composite Bill will, for the first time, provide a national legislative framework for operating donation and transplant services in Ireland.
Speaking after the government decision, Minister Donnelly said:
"I am delighted to have secured government approval for the Human Tissue Bill. This is a significant piece of legislation that includes provisions around organ donation and transplantation, post-mortem practice and procedures in hospital settings, anatomical examination, and public display of bodies after death.
"Crucially, the Bill will embed in legislation the idea that consent is the defining principle across all these sensitive areas and will establish a regulatory framework for the conduct of these activities.
"A key priority for me in bringing forward this legislation is to support organ donation and transplantation in Ireland and to make organ donation ‘the norm’ in situations where the opportunity arises. This Bill will help achieve this through the introduction of a soft opt-out system of consent and pathways for living organ donation and altruistic donation, all of which will help increase the donor pool in Ireland."
Separately, the Bill also introduces a regulatory regime for the conduct of post-mortems in hospital settings to be overseen by the Health Information & Quality Authority (HIQA).
Addressing the introduction of these regulations, the Minister said:
"The Bill also recognises the need to introduce safeguards to protect the integrity of the human body before and after death. Crucially, it will implement the recommendations of the Madden Report regarding consent provisions while the independent regulatory regime being established will help to ensure that the new best practice guidelines being developed by the HSE are complied with by every hospital across the country."
The Bill also puts in place arrangements in relation to the practice of anatomy and will legislate for the governance of the public display of bodies in Ireland.
The Bill will be published in the coming days and is expected to be brought to the Oireachtas shortly thereafter.
The Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill has been drafted to legislate to:
The Bill introduces a new statutory requirement for consent across all of these activities as well as safeguards to protect the integrity of the human body before and after death and to prevent any organ retention without consent in the future.
The Human Tissue Bill introduces a soft opt-out system of consent for organ donation. Under this system, consent for organ donation will be deemed unless the person has, while alive, registered his/her wish not to become an organ donor after death. This is a change from the current system where decisions on organ donation are the responsibility of the next-of-kin and assumes that an individual has a desire to donate their organs after their death unless they make a statement of objection to donation. The next of kin will continue to be consulted before any action is taken, and the wishes of the deceased should be central to this decision.
The Bill further provides a framework for the donation of organs and tissues and cells from living donors including the introduction of a legislative basis for non-directed altruistic living donation.
It is anticipated that these measures will help increase the donor pool in the State and will encourage organ donation to save lives in circumstances where this is possible.
The Human Tissue Bill introduces 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 families when seeking such consent.
The Bill also amends the Coroner’s Acts 1962-2020 to introduce additional provisions for communication and information sharing with families in cases where a coronial post-mortem is required (additional detail below).
The Bill further provides for regulation of the retention, storage, use, disposal and return of organs and tissue from deceased persons following all post-mortems in hospital settings.
The legislation will lead to improved standards of practice across both the coronial and non-coronial system and will complement updated guidelines currently being drafted by the HSE which are scheduled for publication by the end of the year.
The amendment to section 33 of the Coroners Act will:
The amendment of section 57 of the Coroners Act will introduce a more formal process for the final interactions between a coroner, the family and a nominated person in a hospital or other facility.
A coroner must ensure that family members are made aware, as soon as practicable, that any material retained following a post-mortem examination is no longer required.
This notification will advise the family member to contact the nominated person in a hospital or other facility to arrange for the authorisation for the final disposition of the material.
The nominated person will then act on that authorisation.
Where no authorisation has been received or efforts to make contact have been unsuccessful, a coroner is authorised to direct the disposal of material. Such material may include material considered of a historic nature, which may have been stored for a long period and whose retention serves no further purpose.
The Human Tissue Bill repeals the Anatomy Act 1832 and puts in place arrangements in relation to the donation of bodies to anatomy schools and provisions for the setting of standards to be met in the practice of anatomy.
There is currently no legislation governing the public display of bodies. Consequently, the State has no powers to investigate the provenance of bodies on public display and to intervene if required.
Under the Bill, a license will be required for the public display of bodies after death. The provisions in the legislation outline the consent arrangements required for the donation of a body or body parts for public display and ensure the provenance of the specimens used.