Minister for Health welcomes the passage of landmark Human Tissue Bill 2022 through the Dáil

The Minister for Health Stephen Donnelly has welcomed the passing of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill 2022 in the Dáil this evening.

The Bill represents a significant step forward in the regulation of human tissue use in Ireland. It provides a comprehensive legal framework for the donation of organs for transplantation, the carrying out of post-mortem examinations, the use of bodies and body parts for anatomical examination and education, and the public display of bodies and body parts.

The Bill will embed in law the idea that consent, where appropriate, is the defining principle across these sensitive areas and introduce safeguards to protect the integrity of the human body before and after death.

Minister for Health Stephen Donnelly said:

The Minister expressed gratitude to all those who contributed to the development and passage of the Bill, including healthcare professionals, patient advocacy groups, legal experts, and members of the Dáil.

Minister Donnelly concluded:

The Bill will now proceed to the Seanad for consideration.

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; to introduce regulations for both non-coronial and coronial post-mortem examinations in hospital and non-hospital settings;
• general conditions and regulations for anatomical examination; and
• 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; and
• 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

Anatomical examination

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.