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Minister for Health, Stephen Donnelly TD, will introduce the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill for Second Stage debate in the Dáil later today.
The Bill includes provisions around organ donation and transplantation, post-mortem practice and procedures in hospital settings, anatomical examination, and public display of bodies after death.
Speaking ahead of the debate, Minister Donnelly said:
I am proud to be introducing this landmark piece of legislation to the Dáil. The Bill will, for the first time, provide a national legislative framework to support donation and transplant services in Ireland. This will help increase the donor pool, but it is important to say that families will continue to be consulted ahead of donation and those individuals who object, for whatever reason, will be able to opt-out.
Transplantation is currently the only available treatment for end-stage heart, lung and liver failure. It is also the most cost-effective treatment for end-stage kidney disease, and it brings enormous clinical and social benefits to patients who would otherwise remain on dialysis.
Separately, the Bill will also introduce a new regulatory regime to ensure best practice is followed in respect of post-mortem and organ retention.
In line with the recommendations of the Madden Report, the Bill introduces consent provisions for non-coronial post-mortems and sets out a clear framework for how consent should be obtained.
Minister Donnelly added:
The Bill recognises the need to introduce safeguards to protect the integrity of the human body before and after death. It will make consent for non-coronial post-mortems compulsory and will improve communication and information-sharing with families for all post-mortems, including those conducted under the direction of the coroner.
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 Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill has been drafted to legislate to:
- Provide general conditions for the removal, donation and use of organs and tissue from deceased and living persons for transplantation; regulate practice and procedures for post-mortems in hospital settings.
- Provide general conditions and regulations for anatomical examination; and
- Provide general conditions and regulations for public display of bodies after death.
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.
Organ donation and transplantation:
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.
Although the wishes of the deceased should be central to any decision, families will continue to be consulted as part of a safe and respectful organ donation process.
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.
Post-Mortem Practice and Procedure:
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.
Coroners Act amendments:
The amendment to section 33 of the Coroners Act will:
- Ensure the family is informed as soon as practicable that material removed during the examination may be retained for the purposes of the death investigation and of the location of the hospital or other facility.
- Ensure the family is made aware that further authorisation may be required from them regarding the disposition of material retained.
- Provide that any material removed from the body in a hospital will be preserved, stored, and recorded in accordance with regulations made by the Minister for Health or by the Minister for Justice in respect of another facility.
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.
Public Display of Bodies:
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.