Ms Mary Jackson:

I thank the Chairman for the opportunity to address the committee on this important issue. I am joined by my colleagues who are also involved in shaping organ donation and transplantation policy. Dr. Siobhán O'Sullivan is chief bioethics officer to the Department of Health and she is also a member of the Council of Europe committee on bioethics and of the HSE's national consent advisory group. Dr. Patrick Costello is blood, tissues and organs manager for the IMB, which is the competent authority authorising organ donation and transplantation under Ireland's EU regulations.

A priority for our health system is to ensure that every link in the donation and transplantation chain is safe. EU Directive 2010/53/EC, which was transposed into Irish law by SI No. 325 of 27 August 2012 has set criteria for quality and safety and enshrined them in law. The IMB is working with Professor Egan in the HSE's national organ donation and transplantation office to ensure organ procurement and the activities in Ireland's three transplantation centres at Beaumont Hospital, the Mater Hospital and St. Vincent's Hospital meet these criteria.

In addition to mandatory standards for quality and safety, the EU has set out a ten-point action plan on organ donation and transplantation, which aims to strengthen co-operation between member states to increase organ availability and enhance the efficiency and accessibility of transplantation systems, while, at the same time, improving quality and safety. The actions, to be implemented by member states are to promote the role of transplant donor co-ordinators in every hospital where there is potential for organ donation; promote quality improvement programmes in every hospital where there is a potential for organ donation; exchange best practice on living donation programmes among member states: improve the knowledge and communication skills of health professionals and patient support groups on organ transplantation; facilitate the identification of organ donors across Europe and cross-border donation in Europe; enhance the organisational models of organ donation and transplantation in member states; promote EU wide agreements on aspects of transplantation medicine; facilitate the interchange of organs between national authorities; evaluate post-transplantation results; and promote a common accreditation system for organ donation, procurement and transplantation programmes. Ireland is prioritising areas for attention from this list, which will positively impact on organ donor rates.

Another major initiative is the programme for Government commitment to legislate to change to an opt-out system for organ donation about which we have heard a great deal during these hearings. This commitment will require legislation and has divided members of the clinical community and the voluntary sector. However, as we have seen in other jurisdictions, it is not the legislative base, but the infrastructure and donation and transplantation systems in place, and how potential donors and their families are encouraged to donate, that make the difference in increasing the number of donations. Ireland is among a minority of EU member states, including the United Kingdom, the Netherlands and Germany that do not operate an opt-out system.

We must change the cultural attitude towards organ donation and make organ donation the norm in Ireland. The present system of consent will change to one of "presumed" or "deemed" consent, which means that the consent of an individual to organ donation is deemed or presumed to have been given unless they objected during their lifetime. If a person does not wish to become an organ donor after death, they will need to register an objection during their lifetime - a process known as opting out. The deceased's family or next of kin will still have an important role to play in the process of organ donation, as we heard strongly from the presentations earlier. While the next of kin will not be required to give their consent to the donation itself, they will be asked to provide as much information as possible on the person's medical and social history. The Minister has stressed that there would be no instance whereby organ donation would proceed against the wishes of the deceased's family. The system to be introduced is, therefore, a "soft opt-out" system.

The Department is drafting the heads of a human tissue Bill, which will legislate for the giving of consent for the removal, retention, storage, use and disposal of organs and tissues from deceased persons in the context of post mortems, transplantation, research or anatomical examination. The Bill will also legislate for consent for the use of organs and tissues removed from a living person for transplantation and research. The logistics of establishing a system of presumed consent are complex. Many factors, other than the introduction of a system of presumed consent, affect organ donation rates. The availability of donors, transplantation infrastructure, public attitude, and investment in health care all play a role. The Department, in conjunction with the HSE's national organ donation and transplantation office, is considering what practices and organisational changes, along with a change to the consent system, will further improve donation rates in this country. A secure information technology system must be established and maintained. The Welsh Government, which is planning to introduce an opt-out system, envisaged that this would cost more than €5 million for ten years for a population that is two thirds that of the Ireland.

In the absence of a personal unique health identifier, the identification of individuals and the maintenance of a national registry of potential donors is problematic. An opt-out system would require an extensive and well resourced communications strategy. Measures would have to be put in place and sustained to protect the rights of vulnerable groups and the marginalised members of our society. For example, how would a homeless person, or a person who lacks capacity register his or her wish to opt out? The Department will commence a consultation process on presumed consent in the next few weeks and will invite interested parties to submit their views on the practical aspects of introducing this system. We will pose a range of questions, allow approximately six weeks for consultation, distil the information received and then have a focused workshop on the findings of this consultation.

The workshop will involve clinicians, the HSE, Irish Donor Network representatives and other relevant parties to give direction to the next steps, the shape of the legislation and what is needed in the health system to implement a soft opt-out system. We would also be pleased to have representatives of this committee in attendance on the day.

The health system must put people and patients at the centre of everything we do. The Irish Donor Network gave an important input to discussions on the detail of the implementation of Irish regulations on quality and safety in donation and transplantation. Its member organisations - the Alpha One Foundation, Cystic Fibrosis Ireland, the Irish Kidney Association, the Irish Heart and Lung Transplant Association and the Irish Lung Fibrosis Association - will continue to be partners in the development of policy and actions. Indeed, representatives of the network met the Minister in February to provide its members’ views to him, especially on the issue of consent to transplantation. The network also pointed to service areas where improvements could be made to enhance donation and transplantation potential.

I thank the committee for giving me the opportunity to present the Department’s position today. Two clear messages came from the presentations given by the representatives of organisations and individuals who appeared before the committee. First, like other countries throughout Europe, Ireland has waiting lists for transplantation. Second, legislation alone will not solve the problem, but we must work together to increase Irish organ donation and transplantation rates.

A framework to ensure quality and safety is being developed and enhanced. In parallel with this, we must make organ donation the default position for most people and maximise the number of organs available for transplantation. We must ensure that our hospital system is resourced to provide as many people as possible with the gift of life through organ transplantation.