Stephen Donnelly (Wicklow, Fianna Fail) | Oireachtas source

I move: "That the Bill be now read a Second Time."

It gives me great pleasure to introduce the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill 2022 to the Dáil. It is important landmark legislation and includes provisions around organ donation and transplantation, post-mortem practice and procedures, anatomical examination and public display of bodies after death. Crucially, this Bill will embed in law the concept that consent, where appropriate, is the defining principle around these sensitive areas, and will establish a regulatory framework for the conduct of these activities. As committed to by the Government, the drafting of this Bill has been prioritised in order to provide a national legislative framework for organ donation and transplant services in Ireland for the first time. In addition to addressing organ donation and transplant, the Bill will bring the State in line with international best practice in relation to governance of activities relating to human tissue. A priority for me as Minister 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 an opt-out system of consent, and by creating pathways for living organ donation and altruistic donation.

Organ donation is a precious gift and often, the most precious of gifts. It saves lives. Our aim is to help increase the donor pool in Ireland while always fully respecting the wishes of individuals and their families. This approach is strongly endorsed by many of our leading charities who have campaigned for such a system for many years. I acknowledge the presence of some of those campaigners in the Gallery today. For many years, many people have advocated for the move to a position that this Bill will now introduce. An opt-out system, as we know, has already been introduced in some other European countries, including Spain, where the move has helped ensure a very high donation rate.

As we introduce the Bill today, there are approximately 570 men, women and children around Ireland on a transplant list. That is 570 families with men, women and children who are often very sick and who are often in urgent need of organ donation. They are regularly waiting for contact from the health services to say that an opportunity has arisen. Around 570 men, women and children are waiting. Last year, there were 250 organ transplant procedures. By significantly increasing the organ donation pool, which we believe this Bill will, we can go a long way - and hopefully all of the way - to making sure that those who are waiting for transplants in the coming years will be able to access that quicker than has sometimes been the case up to now.

The success of an opt-out system relies on people knowing about their options and being able, easily and quickly, to opt out if that is their wish. This is not about forcing people into donation. It is about making it as easy as possible for an individual’s willingness to donate organs after their death to be acted upon. The Bill also recognises the need to introduce safeguards to protect the integrity of the human body before and after death. The background to much of the proposed legislation is the report on post-mortem practice and procedures. The report was prepared following 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. I want to emphasise that this Bill has quite rightly been drafted following extensive consultation with stakeholders. This has included two public consultations on the proposals, as well as direct contact with interested parties.

The Bill is divided into six Parts, comprising 105 sections. This not only highlights the complexity involved but demonstrates the substantial considerations and work done to develop overarching legislation across several distinct fields. I acknowledge the work done by all involved, including officials in my own Department and across the Government, as well as all of the time that stakeholders and interested parties have given over to making sure we get this law right.

I will now go through the Parts of the Bill. Part 1 is preliminary and general. It provides a list of definitions to aid interpretation of the legislation and includes general provisions for the storage, handling, transportation, disposal and return of organs and tissue. It allows the Minister for Health to introduce guidelines and regulations to support and underpin the legislation. It also introduces provisions for any 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 and is divided into six chapters, comprising 28 sections. It addresses the transplantation of both organs and tissues and outlines the requisite consent provisions with regard to deceased and living donors. 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. The success of transplantation, in terms of life years gained and improvements in quality of life for patients, as well as advances in treatment generally, mean that there are now more patients for whom transplantation is considered to be a viable option than ever before. At the end of last year, 572 people were on transplant waiting lists in Ireland, 512 of whom were on the kidney transplant list. Globally, the most significant problem affecting transplant programmes is the shortage of suitable organs to transplant.

The Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill aims to increase organ donation and transplantation in Ireland through the introduction of new measures including an opt-out system for consent and pathways for living donation by adults, including non-directed altruistic donation. Currently, the decision on organ donation in respect of a deceased person rests entirely with the next of kin, including where the deceased person held an organ donor card or had indicated their wish to be an organ donor on their driving licence. Under the new 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 an opt-out register or are in one of the identified excluded groups. This is often referred to as deemed consent, and will apply to the donation of the heart, lungs, liver, kidneys and pancreas. A separate consent process will be undertaken for the donation of other organs or for tissues and cells from deceased donors.

However, in all scenarios, family members will continue to be consulted before donation takes place. The wishes of the deceased should be central to the decision but if the family objects to the donation, then it will not proceed. I want to be absolutely clear that in no way does the move towards an opt-out approach mean that individual choice on this most sensitive issue is being threatened or eroded. 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 the legislation. 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.

The Bill also provides a framework for living donation.

This has become an increasingly important source of organ donation and it is essential that this type of donation is underpinned by law. The legislation further introduces provisions for non-directed altruistic donation. This means that those who wish to donate a kidney while they are still alive to someone they do not personally know will now be able to do so. At the moment, people who wish to do this must travel to another jurisdiction. This means, of course, that those waiting for an organ transplant in Ireland do not benefit from this most generous action.

Part 3 of the Bill covers pathology practice or post mortems and is divided into three chapters containing a total of 21 sections. The Bill introduces consent provisions for non-coronial post mortems and sets out a clear framework for how consent should be obtained. I want to particularly draw the attention colleagues to a significant departure from what was approved in the general scheme of the Bill.

The legislation now includes provisions that will also 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. The Bill amends the Coroners Acts 1962 to 2022 to introduce a better communication and information sharing process with families in cases where a coronial post mortem is required and where material may be retained for investigative purposes. These important measures are what families impacted by recent controversies have called for and it is important that we respond positively and show that we are listening and learning.

Finally, this part of the Bill provides a framework for obtaining consent for the use of material retained from post-mortem practices by third parties, including pharmaceutical companies, for commercial purposes. The provisions are not intended to regulate the practice of medical research but rather, in keeping with the overall thrust of this legislation, are drafted to ensure that consent is of paramount importance and must be obtained from the family of the deceased before any third-party use. The Bill includes an additional safeguard by mandating that use of material for any commercial purposes must first be authorised by the person in charge of the hospital where the post mortem took place.

Part 4 of the Bill deals with anatomical examination and updates the licensing system for schools of anatomy. It is made up of 23 sections. Believe it or not, currently, the study of anatomy is legislated for under the Anatomy Act 1832. While this Act provides for the granting of a licence to an individual to practice anatomy, it does not include detailed provisions with regard to consent. The human tissue Bill will repeal this outdated Act and put in place arrangements with regard to the donation of bodies to anatomy schools and provisions for the setting of standards to be met in the practice of anatomy.

Part 5 of the Bill legislates for the public display of bodies after death and consists of 19 sections. There is currently no legislation governing the public display of bodies in Ireland. Consequently, the State has no powers to investigate the provenance of bodies on public display and to intervene, if required. The Bill will introduce a licensing system for the public display of bodies after death. There are a number of activities that will be exempt from the requirement of such a licence, however. These include the display of a body as part of a funeral or any similar ceremony held for the purposes of paying respects to a deceased person; the display of a body at a place of public religious worship and where such display is necessary to the act of religious worship; the display of a body in print, photographic or digital form, including on the Internet; or the display of a body for the purposes of recording, by film or otherwise. Further, a licence will not be required for the public display of the body of a person who died at least 100 years before the commencement of the legislation or for bodies already held in schools of anatomy, hospitals, universities, museums or galleries before the law comes into effect.

Part 6, the final Part of the Bill, is another general Part that covers miscellaneous issues. This Part provides for amendments and the repeal of existing legislation to support the functioning of the Bill.

There is much in this Bill. There are many technical issues around the public display of bodies and the practice of anatomy that need to be updated and legislated for. The two aspects to this Bill that are certainly the biggest priorities for me and, I would imagine, colleagues in the House are making sure post mortems are done in the right way and that there is - and must always be - consent from families, which is something that has not always happened and has involved practices that should not have happened in this country. This Bill will mandate under law that there must always be consent, which is right and proper. It is very important.

The second aspect is that we are essentially moving from an opt-in to an opt-out organ donation system. I have no doubt but that this will increase the donor pool. We know it has worked very effectively in Spain. We will need to wait to see what the impact is here but I anticipate there will be an increase in that donor pool. What that means for the 570 men, women and children on the waiting list today and their families, friends and communities is that the time many of them must wait will be shorter. They can get the organ donations sooner, which comes with enormous benefits in terms of their health and being able to get on get on with their lives. It is, therefore, important legislation. I thank all those who advocated in the Oireachtas and in civil society for this move. I am happy to stand in the Chamber this evening as Minister of Health to begin the passage of this Bill through the Oireachtas.

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