The Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act was signed into law on 26th February 2024 and provides a robust, transparent and ethical legal framework for: –

Most notably for our transplant community, it introduces a soft opt-out system of consent for organ donation, when 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 system, in addition to a framework for the donation of organs, tissues and cells from living donors, is anticipated to encourage further donation, thereby increasing the donor pool in Ireland.

Prior to the enactment of this legislation, the family of a potential organ donor were approached for consent to remove life-saving organs from their loved one. In accordance with the new Act, which introduces an opt-out system of donation, a designated family member will be approached for assent, so long as the potential donor has not opted out of organ donation while living.

The new system of donation, with its objective to increase the number of organ donations in Ireland, has been welcomed by several leading Irish organ donation charities, namely, the Irish Donor Network (Cystic Fibrosis Ireland, Irish Heart and Lung Transplant Association, ILFA, Alpha-One Ireland, Cystinosis Ireland, Pulmonary Hypertension Association of Ireland and COPD Support Ireland), the Irish Kidney Association (IKA), Cystic Fibrosis Ireland (CFI) and the Irish Lung Fibrosis Association (ILFA).

LISN welcomes its enactment and acknowledges the efforts made by the Minister for Health, Stephen Donnelly TD, and his team in guiding this long sought-for legislation through the statutory stages within the Oireachtas. We support the introduction of an opt-out system of organ donation and acknowledge the commitment to increase the donor pool in Ireland. With circa 700 people awaiting organ transplants annually, almost 80 of these necessitating a life-saving donor liver, the demand for donor organs continues to exceed supply. Furthermore, the current waiting time for a liver transplant is to 12 to 24 months (Irish Liver Foundation ), during which time a patient with a diseased liver must remain adequately healthy and stable to undergo a transplant; a very challenging and difficult surgery. This pre-transplant phase places significant pressure on a patient, family and loved ones, in addition to medical personnel and others caring for this patient, as well as a monetary burden on the HSE while patients are being treated for their chronic illnesses (HSE, 2024 ).

While supportive of the soft opt-out system, we query whether the ‘soft’ approach will achieve sufficient traction to provide more life-saving donor livers? In the absence of urgent educational campaigns and the provision of clarity and practical guidelines on this new system, we wonder if the implications of the opt-out system on donation rates will vary hugely from the previous donation system, in which family member consent was at the fore, despite the wishes of a potential donor, during his / her life. The new opt-out system also requires assent from a dedicated family member, implying that even if a person did not register to opt out of donation, carried a donor card or indicated his / her wishes to donate during life, these wishes may not be fulfilled at death. We urge the rolling out of educational campaigns and the provision of more clarity on this system by the Department of Health without delay, including the prompt preparation of practical guidelines, as described in Section 6 of the Act. We also urge the promotion of family discussions on this topic on a number of advertising media.

Moreover, we believe that the soft opt-out system just the first step of the process of increasing the donor pool, and thereby transplantation surgeries. To further increase the number of liver transplants per million population (pmp), a continuous commitment to research and innovation, infrastructural investments and expansion of transplant centres are vital, complemented by intensive staff training, expanded criteria for organ donation, the presence of transplant coordination teams in ICU settings and a more donation-focused approach by end-of-life carers.

The Spanish model of donation and transplantation is recognised as the gold standard worldwide. Of the reasons for their success, Spanish authorities and transplant researchers do not list the opt-out system, in place there since 1979. Instead, they credit elements including, inter alia, public trust, genuine commitment to donor organ procurement, training and professional development, quality assurance, living donor coordinators, HCV (hepatitis C virus) eradication plan and expanded criteria for organ donation and living donors (Streit et al, 2023 ).

There are lessons to learn from Spain and other high-performing countries such as Italy and Croatia. Commitment is key.

On average, ONE donor can save FIVE lives. Many of the members of LISN never imagined that they would require a liver transplant one day…