Professor Jim Egan:

I thank the joint committee for the invitation to discuss the Bill. I am a consultant lung transplant physician based at the Mater Misericordiae University Hospital and the director of Organ Donation Transplant Ireland, ODTI. I am also the chairman of the national organ donation and transplant advisory group, NODTAG, which informs and supports ODTI. The NODTAG includes representation from the three national transplant centres and the intensive care medicine community. I am joined by my colleague Ms Fiona Hammond, chief operations officer of ODTI.

ODTI is the delegated body for organ donation and transplant and performs the functions assigned to the HSE. It is authorised by the HPRA in accordance with SI 325 of 2012, European Communities Quality and Safety of Human Organs Intended for Transplantation. It is the responsible national body for the independent co-ordination and safe management of organ procurement through the National Organ Procurement Service, NOPS. This involves collecting organs and moving them to transplant centres. The NOPS co-ordinates the organ donation process with the support of the three national transplant centres, namely, the National Renal Transplant Centre in Beaumont University Hospital, the National Liver and Pancreas Transplant Centre, St. Vincent’s University Hospital and the National Heart and Lung Transplant Centre in the Mater Misericordiae University Hospital

ODTI works closely with the intensive care services throughout the country from the point of referral to the safe hand-over of donated organs for transplant surgery. It acts as a confidential communication channel for donor families and recipients of organs. It also provides access to supports for families who have donated organs.

ODTI is underpinned by robust quality processes and has a quality management system which provides for benchmarking against EU standards. This ensures safety for the donor, families and transplant recipients.

ODTI welcomes the introduction of the Human Tissue Bill and the inclusion of a “soft opt-out” approach to organ donation. In Ireland there are 577 individuals listed for life saving transplant surgery. Historically, organ donation in Ireland has functioned on the basis of voluntarism and clinical interest in organ donation. Continual improvements in healthcare such as early intervention and enhanced treatments for stroke patients and a very welcome 60% reduction in the number of deaths in road traffic accidents in the past ten years have reduced the traditional organ donation events. Therefore, organ donation continues to be a very rare event. Of 31,000 deaths each year in Ireland, there is an average of 80 multi-organ donations per annum. While Ireland performs well when compared to other European counterparts, organ donation rates are consistently dominated by those countries that provide for both opt-out consent and have robust organ donation infrastructure. My submission includes a map showing the other countries that use a soft opt-out approach, to which the United Kingdom has recently moved. Spain is widely acknowledged as having the leading model of a system that has increased the rate of organ donations. It operates a soft opt-out system. However, the Spanish national body for organ donation and transplant, ONT, Organización Nacional de Trasplantes, emphasises the importance of organ donor infrastructure to support organ donation. It entails the availability of key donation personnel, donor co-ordinators, to support families through the organ donation process.

In 1989, 14 per million of the Spanish population donated organs. With the changes to the approach adopted in recent decades, this figure has risen to 45 donations per million of population. Significantly, 30% of donations in Spain are from individuals aged over 70 years which compares to a figure of less than 6% in Ireland. While organ donation from older individuals is feasible, it is medically more complex and requires appropriate infrastructure in order to execute the transplant safely. My submission includes a table which shows where Ireland sits in a European context. We should acknowledge that, thankfully, Ireland has low death rates. As we are in the business of saving lives, we are in the middle of the table overall, but there is room for improvement.

Recognising the many benefits that accrue from transplantation, the United Kingdom has invested substantially in organ donation and transplantation. In 2008 in the United Kingdom an organ donation task force made a series of recommendations to enhance national organ donation rates. They have resulted in a 75% increase in organ donation rates.

Per capita, the UK spends significantly more than Ireland on organ donation infrastructure. There is currently a significant infrastructure deficit in regard to organ donation in our health service. In table II of our submission we have benchmarked Ireland against our closest neighbour, Northern Ireland and against the best in Europe. As can be seen, we operate with about one third of the equivalent organ donation infrastructure. There is clearly a spread across Europe in how in the infrastructure is deployed.

Organ donation typically occurs with a diagnosis of brain death, which is actually a very uncommon form of death, frequently occurring as a result of injury to the brain. An alternative, modern technique, which is called deceased cardiac donation, or DCD, allows organ donation after the heart stops beating. This approach has allowed many EU countries to safely enhance their number of donations. The UK has made significant progress by focusing on this form of donation. Currently up to 40% of all UK donations occur in these circumstances. Overall, in any population, cardiac death is the most common mechanism of death but because blood flow is interrupted, preservation of the organs is more complex. Consequently, donation after the heart stops beating places extra demands on surgical retrieval staff, who are then displaced and unavailable for subsequent transplant surgery. Therefore, in keeping with international experience, the combination of donations from older people and deceased cardiac donation, with the adoption of a soft opt out, should allow donation rates in Ireland to increase. Appropriate organ donation infrastructure would save many lives and decrease the burden of costly interventions such as dialysis which costs around €65,000 per annum versus approximately €12,000 for kidney transplant surgery. Table III illustrates the success of the renal services in this country, with an increasing number of people sustained on dialysis over the last decade. ODTI will continue to work with the Department of Health in securing appropriate infrastructure funding for donation and transplant services in Ireland.

An organ donation opt-out register is central to the human tissue Bill which provides that such a register will be established and maintained by ODTI. Spain does not operate a register and relies on organ donation personnel to support families through the process. In contrast, the UK currently operates both a positive register, where people declare their desire to be a donor and a negative register, where people declare that they do not want to be a donor. The British have invested heavily in that. The proposed Irish register will be provided for those individuals who do not wish to participate in organ donation after death. We anticipate this will represent approximately 5% of the population based on an analysis of what happened in Wales when it introduced a similar system. ODTI is currently working to scope the operational and technical requirements of the development of the national register. As this is a complex project, ODTI will have the support and expertise of the HSE's office of the chief information officer, OCIO. The project will develop the operational processes that allows for a GDPR-compliant national opt-out register for organ donation, including the secure hosting of its national database. ODTI will identify the safest and most cost effective electronic register for demographic identifiers of individuals who wish to register an objection to organ donation. Working with the OCIO, ODTI will ensure the inclusion of an ability to link to a national individual health identifier, IHI, when it becomes available. The register will also provide a mechanism to allow people to alter their information on the register or to revoke their objection should they wish to do so at a future date. ODTI will ensure the register will not be open to inspection by the public. As per the proposed legislation, it is intended that ODTI may share information only with relevant medical staff for the purpose of determining if the deceased person’s family members may be approached to discuss organ donation. This capability must be available to the entire acute hospital network, on a 24/7 basis, 365 days per year. It is intended that target medical staff will include organ donation nurse managers, intensive care consultants with special interest in organ donation, intensive care consultants, intensive care nurses and emergency medicine consultants.

ODTI wishes to highlight the need for a robust national public awareness campaign to support the introduction of a soft opt-out system of consent for organ donation and for the associated register in Ireland. This will be required in advance of the introduction of a soft opt-out consent system.

Organ donation saves lives and should be the society norm. Of 31,000 deaths in Ireland, donation occurs on average only 80 times each year. There are currently 577 people awaiting transplant surgery. The Irish health service operates with one third of the equivalent international infrastructure for organ donation and transplant. ODTI provides a framework for organ donation and transplantation and each year publishes an activity report which is accessible to the public. We have included some European league tables in our submission so that committee members can benchmark us against our European counterparts. I thank the Chairman and committee members for their attention this morning.