Stephen Donnelly (Wicklow, Fianna Fail) | Oireachtas source

I thank the Leas-Chathaoirleach. I am delighted to be here.

I am extremely pleased to introduce this legislation. This Bill contains several different measures, but it is important for two main reasons. First, it will introduce in our country for the first time an opt-out system for organ donation. Under this measure, it will be taken that every one of us has opted to be an organ donor unless we register to opt out of this. Our sincere hope is that this will increase the number of organs available for transplant. As we know, this offers life-changing and life-saving opportunities to all those waiting for transplants. About 600 people in Ireland are today waiting for a transplant. Second, this Bill puts on a clear legal footing a process for post mortems and the treatment of remains, including the treatment of organs, in such a way that the wishes of the family are front and centre. This will ensure organ retention issues that have happened in the past, which should not have happened, can never happen again.

I will now go through the detail of the Bill. Part 1 covers preliminary and general matters. It provides a list of definitions to aid the interpretation of the legislation and includes general provisions. It allows the Minister for Health to introduce guidelines and regulations. This Part also introduces provisions for a designated family member to be consulted prior to donation of organs and tissues from deceased persons and for the conduct of non-coronial post mortems.

Part 2 of the Bill deals with donation and transplantation matters. It addresses the transplantation of both organs and tissues and outlines the requisite consent provisions with regard to deceased and living donors.A priority for me as Minister in bringing forward this legislation is to support organ donation and transplantation and to make organ donation the norm in situations where that operation is appropriate. This Bill will help to achieve this through the introduction of a soft opt-out system of consent and by creating pathways for living organ donation for altruistic donation. Under this new soft opt-out system, all adults in Ireland will be considered to have agreed to be an organ donor when they die unless they have recorded a decision not to donate on the opt-out register or are in one of the identified excluded groups. Those who object to organ donation for whatever reason will be able to record their objection on a new register that will be established under legislation by the HSE. In such cases their wishes will be respected and their family will not be approached on the issue of organ donation. It will be possible for individuals to remove their name from the register at any time. If someone has not registered their objection on the register, their family members will continue to be consulted before donation takes place. The wishes of the deceased should be central to the decision to donate but, if the family objects to the donation, it will not proceed. Our aim is to help to increase the donor pool in Ireland while always fully respecting the wishes of individuals and their families. The Bill also provides a framework for living donation and introduces provisions for non-directed altruistic donation.

Part 3 of the Bill covers pathology practice or post mortems. The background to much of this Part of the Bill is the Madden report, which resulted from the discovery in the late 1990s that it was hospital practice for many years to perform post mortem examinations and to retain organs of deceased children without family knowledge or permission. I deeply regret that similar issues and concerns have arisen in our hospitals more recently. In line with 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. I wish to draw the attention of the House to a significant departure from what was approved in the General Scheme of the Bill. The legislation now includes provisions that will bring certain aspects of coronial post mortem practice under the framework of this Bill. These provisions reflect the reality that approximately 98% of post mortems conducted in Ireland are performed under the direction of the coroner and will apply to coronial post mortems in both hospital and non-hospital settings. The Bill amends the Coroners Acts 1962 to 2022 to address issues regarding material removed and retained from a deceased person in a post mortem examination directed by a coroner in non-hospital settings such as the Dublin city mortuary. These important measures are what families impacted by recent controversies have called for. It is absolutely vital that we respond positively and show that we are listening, learning and, most importantly, acting on their wishes.

Part 4 of the Bill deals with anatomical examination and updates the licensing system for schools of anatomy.

Part 5 of the Bill deals with the public display of bodies after death. The Bill will introduce a licensing system for the public display of bodies after death.

On Committee Stage in the Dáil I brought forward several amendments, some of which were part of the Government decision when the Bill was approved in November 2022. These amendments were to ensure the proper functioning of the legislation in line with the policy objectives of the Bill and were mostly technical and consequential in nature.

Several amendments were introduced on Report Stage in the Dáil, all of which seek to ensure the legislation aligns with policy intent. Two amendments were made to Part 2 of the Bill, on organ donation and transplantation. I have provided for a review that will examine the impact of the opt-out register on organ donation and transplantation in Ireland, to be carried out three years after commencement of Part 2 of the Bill. A further amendment was made to this Part so that there may be two patient advocates on the independent panel for organ donation, at least one of whom may be a patient donor advocate. These amendments arose from my engagement with the Irish Kidney Association.

I acknowledge the Irish Kidney Association's work and indeed the work of other civil society and patient advocacy groups in Ireland. We have engaged with them at length. The Leas-Chathaoirleach and I met with the Irish Kidney Association recently. Several of the amendments that were brought forward on Report Stage were consequent to that meeting and to various requests the association had made. I acknowledge that there has been constructive and positive engagement across the board between myself, Members of both Houses, my Department, the Irish Kidney Association and the other fantastic groups that work in this space. I thank them for all of their constructive input. We have updated the Bill and I have introduced amendments through the Stages to try to reflect what patients, families and their advocacy groups have been looking for.

Several amendments were introduced to Part 3 of the Bill. The Coroners Act has been amended to provide for the regulation of the retention, storage, use, disposal and return of organs and tissue from deceased persons following all post mortems in hospital settings, including those directed by a coroner. Amendments have been made to expand HIQA's role to include the monitoring of regulations for post mortem examinations that take place in locations other than hospitals, such as the Dublin city mortuary. An amendment was made to the Health Act 2004 to expand protected disclosure provisions to HIQA to include disclosures made to the authority relating to its role in monitoring compliance with regulations under the human tissue Bill and the Coroners Act.

I would like to flag an amendment which I will bring forward on Committee Stage in this House. It will attempt to connect this legislation with changes relating to the legal framework of capacity and consent brought in by the commencement of the Assisted Decision-Making Capacity (Amendment) Act 2022.

As Senators will appreciate, this legislation means a great deal to many people. I look forward to working with Members of the House constructively on its progress.