Anotomy

Modern Act

Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024

The Human Tissue Act is a composite piece of legislation that includes provisions on

• Organ donation and transplantation
• Post-mortem practices and procedures
• Anatomical examination
• Public display of bodies after death

The introduction of the legislation brings Ireland into line with international practice in relation to governance of practices relating to human tissue. It is the international norm to have primary legislation governing organ donation and transplantation, and the Act introduces Ireland’s first legislative framework in this area.

Purpose

The purpose of the Act is to embed in legislation the idea that consent is the defining principle across all practices relating to human tissue and to introduce necessary safeguards and regulation across these areas.

The Act is intended to support and increase organ donation and transplantation in Ireland. It will introduce a soft opt-out system of consent, where consent for organ donation is deemed unless the person has, while alive, registered his/her wish not to become an organ donor after death. The Act will also broaden the donor pool through the introduction of frameworks for living donation, including for non-directed altruistic donation.

Separately, the Act also addresses many of the concerns raised in the Report of Dr Deirdre Madden on Post-Mortem Practice and Procedures (2005) by introducing a statutory requirement for consent for non-coronial post-mortems and by providing for regulation of post-mortems in hospital settings.

The Act repeals the Anatomy Act of 1832 and replaces it with legislative arrangements governing the donation of bodies to anatomy schools and standards to be met in the practice of anatomy.  The Act includes provisions for the governance of the public display of bodies in Ireland.

Anatomical Examination

Part 4 of the 2024 Act will only apply to anatomical examinations that occur after the commencement of the section and exempts examinations that have begun under the provisions of the Anatomy Act 1832.

There are conditions for obtaining consent from an individual who wishes to donate their body for anatomical examination and provides for the Medical Council, as regulator, to specify particular requirements around consent. It  prohibits payment or other inducements for such consent and makes it an offence to conduct an anatomical examination without consent.

A body is to be transferred to a licensed institution before a death is registered. A Medical Certificate of Cause of Death must be signed before an anatomical examination can take place. The Medical Certificate of Cause of Death must be retained by the licensed institution which received the body.

Practice of Anatomical Examination

The 2023 Act prescribes who is authorised to perform an anatomical examination and prohibits the performance of such examinations in locations other than licensed institutions. It also confers responsibility for the donor’s body or parts of the body to the licensed institution from time of receipt until burial, cremation or return.

There are conditions under which the loan or transfer of anatomical specimens is permitted for the purposes of anatomical examination. Loan or transfer is only permitted between institutions on the island of Ireland. This is subject to pre-authorisation from the Medical Council, as regulator.

Both the institution which lends or transfers the specimen and the institution which receives the loan or transfer must be able to provide the Medical Council, if requested, with evidence the loan or transfer was made with any consent given by the donor and in accordance with the provisions of this Part.

Importation of Anatomical Specimens

The 2024 Act sets out the conditions under which anatomical specimens can be imported for anatomical examination. Importation is subject to pre- authorisation from the Medical Council and an anatomical specimen must be obtained, transported, used, and disposed of in accordance with any consent given by the donor. There are processes to be followed by an institution that wishes to apply for a licence to perform anatomical examinations. It includes a grandfathering clause for institutions already licensed under the Anatomy Act 1832.

There are processes to be followed by the Medical Council when issuing a licence for anatomical examination following a successful application from an institution. A licensed institution can apply to have its licence amended.

The Medical Council may  remove, add, or amend conditions relating to a licence. It outlines the process to be followed for doing same. There is a procedure which  the Medical Council must follow if it intends to suspend or revoke a licence and details the conditions under which it can take such action.

The  Medical Council may suspend a licence without notice in certain circumstances. Procedures are to be followed when taking such action. There is provision for any licensed institution aggrieved by such notice to make an application to the High Court. A licensed institution may appeal a decision by the Medical Council in circumstances other than when a licence has been suspended without notice.

Responsible persons

A licensed institution must identify a responsible person who will serve as the main contact point for the regulator as well as fulfilling other responsibilities in the legislation. The Act delineates the responsibilities of the responsible person for the purposes of this Part and allows for appropriate delegation of their functions.

Records are to be kept in relation to donated anatomical specimens for the purposes of anatomical examination. There is record keeping where a specimen is loaned, transferred or disposed of.

The 2024 Act provides for the transfer of functions from an Inspector of Anatomy granted powers under the Anatomy Act of 1832 to the Medical Council. Certain functions are to be undertaken by the Medical Council which  shall have all the powers necessary or expedient to perform its functions under this Part.

The Medical Council may  request any information it deems necessary from a licensed or applicant institution in order to fulfil its functions under Part 4. It further stipulates that such requests must be complied with by the relevant institution.

The Medical Council  appoint authorised officers for the purpose of regulation under Part 4 of the 2024 Act. The powers of authorised officers are set out. There are requirements of those being inspected and it is an offence to obstruct or not comply with an authorised officer.

Anatomical Examination

There is a process by which the Medical Council can prepare, publish, amend or revoke a code of practice for anatomical examinations or approve any other code of practice relating to the undertaking of anatomical examinations as it deems necessary. Consent to the publication or approval, as the case may be, of such codes of practice is by the Minister for Health.

There are circumstances whereby the Medical Council may issue a compliance notice under  Part 4. The person on whom the compliance notice has been served may make representations to the Medical Council about the proposed notice. If a person in receipt of a compliance notice fails to comply with that notice, they will be guilty of an offence.

A person in receipt of a compliance notice may appeal such a notice and details the process of appeal.

Public Display Activities

The Act delineates what is encompassed by the term “public display activities” . Specified activities are defined that do not constitute public display for the purposes of the 2024 Act. It prohibits the use of the body of a child, human foetus, embryo or gamete for purposes of public display.

A public display activity cannot take place unless a licence has been issued by the Medical Council in accordance with Part 5. There are  conditions that must be followed by licence holders it is an offence to be in breach of these obligations.

There are  conditions for obtaining consent from an individual who wishes to donate their body for public display. The Medical Council, as regulator, may specify particular requirements around consent. The Act prohibits payment or other inducements for such consent and makes it an offence to engage to display a body in public without a licence or without consent.

A  body may be transferred to a Part 5 licence holder before a death is registered. However,  a Medical Certificate of Cause of Death must be signed before public display can take place. The Medical Certificate of Cause of Death must be retained at the premises of the Part 5 licence holder that received the body.

Licence to undertake Public Display Activities

There is a process for applying for a licence to undertake public display activities. The Act sets out the requirements of both the applicant and the Medical Council in this regard. It also sets out conditions for importing anatomical specimens into Ireland for public display.

There are details of the appeals proposal available to the applicant should the Medical Council refuse a request for a licence. The Act  empowers the Medical Council to remove, add, or vary conditions relating to a licence

Suspension and Revocation

The Act sets out the steps the Medical Council must follow if itspend or revoke a licence and conditions under which it can do so. The Act also includes details of the appeals process available to the Part 5 licence holder in the event the Medical Council should seek to suspend or revoke a licence.

The Medical Council can suspend a licence without notice. Such a suspension should only be considered when there is a danger to life, health, or welfare of the public or an anatomical specimen is not being treated with dignity or respect. There is  provision for the Part 5 licence holder aggrieved by such a decision to make an application to the High Court. There are  procedures for a Part 5 licence holder that wishes to appeal a decision by the Medical Council in circumstance other than when a licence has been suspended without notice.

There are conditions under which the loan or transfer of anatomical specimens for the purposes of public display can take place. Loan or transfer is only permitted between licence holders on the island of Ireland and is subject to pre-authorisation from the Medical Council, as regulator for Part 5.

The 2024 Act sets out the conditions under which anatomical specimens can be imported for public display activities. Importation is subject to pre- authorisation from the Medical Council and the Part 5 licence holder must satisfy himself or herself that any anatomical specimen has been obtained, transported, used, and disposed of in accordance with any consent given by the donor.

There is a requirement on the Part 5 licence holder to keep a register of documents pertaining to anatomical specimens donated for public display. There are documents required in the case of anatomical specimens imported for public display activities and the documents required where other circumstances apply. Failure to maintain a document register is treated as an offence.

Regulators

The Medical Council is to act as regulator under  Part 5 of the 2024 Act. It sets out the responsibilities of the Medical Council in its performance of this function. The Medical Council to appoint authorised officers for the purpose of regulation under the Part. Authorised officers may be appointed, There are requirements of those being inspected and it is an offence to obstruct or not comply with an authorised officer.

The Medical Council can prepare, publish, amend or revoke a code of practice for public display or approve any other code of practice relating to the undertaking of public display as it deems necessary. Consent to the publication or approval, as the case may be, of such codes of practice is by the Minister for Health.

There are circumstances whereby the Medical Council may issue a compliance notice. There are the steps the Council must follow when doing so. The  person on whom the compliance notice is to be served may make representations to the Medical Council about the proposed notice. If a person in receipt of a compliance notice fails to comply with that notice, they will be guilty of an offence. A person in receipt of a compliance notice may appeal such a notice and details the process of appeal.

There are penalties for offences under the Act. There are defences for someone who is accused of an offence under the Act when proceedings are taken against them. The 2024 Act  facilitates information sharing between the regulators of the various parts of the Act. It  designates data controllers for each of the Parts of the Act and outlines how data is to be processed and maintained subject to existing GDPR legislation