Human Tissue Act 2024: History and the future

The Human Tissue (Transplantation, Post-Mortem, Anatomical Examination, and Public Display) Act 2024 was enacted by the President of Ireland Michael D Higgins on 28 February, 2024, after being formally passed in the Dáil on February 21. The Act covers many areas including organ donation and transplantation. In this article, we examine what has happened up to now and what to expect in the future.

History of kidney transplantation in Ireland

The first kidney transplant in Ireland took place in 1963. This was followed by the first heart transplant in 1985, the first pancreas transplant in 1992, the first liver transplant in 1993, and the first lung transplant in 2005.

People also travelled to the UK for transplant surgery, and there continues to be strong links between the two jurisdictions, including the paired kidney exchange programme and other paediatric transplants (except for kidneys) happening in the UK. Figure 1 provides an overview of transplantation in Ireland to date.

One of the first actions of the Irish Kidney Association (IKA) when it was formed in 1978 was to introduce the kidney donor card, which subsequently became the organ donor card we know today. The association has been at the forefront in the promotion of organ donation for over 45 years, and it has been no different in relation to advocating for legislation in the areas of organ donation and transplantation.

The introduction of cyclosporine as an immunosuppressant in the early 1980s was a game changer for organ transplantation. There have been ongoing developments in immunosuppression since, with new medications and finer tuning of doses emerging.

FIGURE 1: Overview of transplantation in Ireland to date

Legislation for organ donation and transplantation

Legislating for organ donation for transplantation has been a work in progress for many years. The Human Body Organs and Human Tissue Bill 2008 lapsed with the dissolution of the Dáil and Seanad in 2011. Senator Mark Daly has been actively supporting the work of the IKA in this area since he first entered the Seanad in 2007.

Under the direction of past and present IKA boards, staff have carried out significant work to influence the development of both domestic and EU policy. Throughout the years, the IKA has brought its experience of promoting organ donation to bear on the debate, as well as its considerable understanding of what happens in other countries and, in many cases, how and why they made changes to how they deliver their service.

After almost 8,000 organ transplants, the Human Tissue Act 2024 will, for the first time, provide a national legislative framework for operating organ donation and transplant services in Ireland, repealing the almost two centuries old Anatomy Act of 1832.

It has been encouraging to see cross-party support for the promotion of organ donation and transplantation services throughout the legislative process. The IKA has been there every step of the way: Providing briefing documents to all parties; advocating for several amendments to improve the bill; and ensuring that the perspectives of patients, donors, and donor families were part of the conversation.

The work carried out by the Association in relation to the legislation has built its reputation as a partner in the future development of services around organ donation and transplantation. Our work included organising an Oireachtas briefing session in November last year, as well as holding meetings with Department of Health officials and the Minister for Health Stephen Donnelly.

While the IKA did not achieve everything we were looking for in relation to amendments, the Minister did agree an amendment that commits to a review of the opt-out register, not later than three years after the commencement of the register itself.

This will be important as it will put organ donation and transplantation on the political agenda again, and also allow for reflection on, and learnings from, the experiences of the preceding three years. At the frontline in promoting organ donation in the community, the IKA will play a key role in this review.

There are many aspects to the Human Tissue Act, with each one requiring preparatory work (training, education, etc) and infrastructure before it can be implemented fully. Therefore, nothing has formally changed yet in relation to practice in hospitals, and the opt-out organ donor register has not yet been established. We are awaiting a timeline for the roll-out of the changes.

FIGURE 2: Overview of current versus new potential organ donor system

What changes will the Human Tissue Act bring?

Altruistic donation: The new Act includes non-directed altruistic donation for the first time. Altruistic kidney donation involves a member of the public stepping forward to donate a kidney to the transplant pool and the recipient will be anonymous.

According to the Human Tissue Act, “a non-directed altruistic donor may not direct or specify that his or her organ shall, or shall not, be donated to a person of a particular class or classes of persons.” To date, if someone wanted to donate a kidney to a stranger (altruistically) they had to go to Belfast or abroad to do so.

The introduction of an opt-out register and presumed consent:
An official online opt-out register will record the details of those who choose not to be considered as a potential organ donors. Figure 2 illustrates how this will change the approach for family approval.

Any person who does not opt-out of the online register will be considered
a willing and potential organ donor. It is important to note that:

• Approximately only 1 per cent of deaths annually occur in circumstances that permit organ donation.
• Organ donation will only go ahead if there is assent (consent) from the family.

In relation to organ donation, the core message for the public remains: ‘Don’t leave your loved ones in doubt.’ The organ donor card can be used to initiate a discussion with patients and their families, so that organ donation decisions are known in advance. Healthcare professionals are also encouraged to have discussions with their own loved ones and to make their personal wishes known.

Future developments

In reviewing this year’s successful Organ Donation Awareness Week campaign (20-27 April, 2024) – organised by the IKA in collaboration with Organ Donation Transplant Ireland – it is rewarding to note how the public engages positively with the topic of organ donation when interacting with the IKA’s volunteers and its social media.

However, two months after the passing of the Human Tissue Act, there remains considerable confusion around current practices in organ donation for transplantation and how the Act will ultimately affect the public. Much of this has been based on the incorrect assumption that the provisions of the Act are already in place. The IKA is convinced that a robust public education programme is crucial. National messaging will need to be underpinned by a community-based information programme.

As a community-based organisation with over 45 years of experience in the promotion of organ donation, the IKA, with appropriate resourcing, is well placed, and already has the public trust, to partner with Government and the HSE in what needs to be an ongoing public education programme.

Such a programme is essential to ensure that everyone understands what the opt-out register means, and how it will function, before it is officially introduced. Similarly, there needs to be clear messaging around other provisions including how altruistic kidney donation will function and considerable preparations to ensure it is robust in how it will work in practice.

FIGURE 3: Dialysis and kidney transplant statistics 2023

FIGURE 4: Key influences in organ donation

Conclusion

The passing of the legislation on February 28, 2024, was historic, but it is not the end of the story in relation to organ donation for transplantation. It is merely the end of a chapter. The next chapter will include the commencement of the relevant parts of the legislation, and it will need to be allocated appropriate resourcing to ensure that the changes in the legislation are meaningful.

It was obviously pleasing to see Minister for Health Stephen Donnelly make an announcement to coincide with the passing in the Dáil of the Bill, committing to increased funding of €1.6 million in 2024 for organ donation and transplant services.