Jan O'Sullivan (Limerick City, Labour) | Oireachtas source

I welcome the opportunity to address the House on this important issue and thank the Deputy Tom Fleming for tabling the motion.

We are all aware of the enormous difference an organ transplant can make to a recipient's life. However, we are also aware of the worldwide shortage of organs available for transplantation and the significant challenge this poses to health services both in Ireland and throughout the world. That is why we must all do our part in encouraging organ donation in order that more organs become available for those who need them. Ireland has a good history of organ donation and transplantation. A total of 5,182 transplants were performed to the end of 2012. The first renal transplant took place in January 1964 and we will be celebrating 50 years of renal transplantation next year. During 2012 there were 78 deceased donors and 32 living kidney donors. A total of 239 solid organ transplants were performed in the three transplant centres in Ireland. These centres are the Mater hospital for heart and lung transplants, Beaumont Hospital for kidney and pancreas transplants and and St. Vincent's University Hospital for liver transplants. However, the Joint Committee on Health and Children was informed last week that over 650 people were awaiting organ transplantation.

The success of any organ procurement and transplantation system is contingent on its capacity to fulfil the following three interconnected objectives: good outcomes in terms of quantity and quality of organs; maintenance of public trust in the transplantation system; and respect for ethical principles. A priority for the health system is to ensure every link in the donation and transplantation chain is safe. EU Directive 2010/53/EC on the quality and safety of organs intended for transplantation which was transposed into Irish law by SI 325 of 27 August 2012 sets standards for quality and safety. In its role as competent authority under these regulations, the Irish Medicines Board is working with the HSE's national organ donation and transplantation office to ensure organ procurement and the activities of the three transplantation centres meet these standards.

In addition to mandatory standards for quality and safety, the European Union has set out a ten point action plan on organ donation and transplantation which aims to strengthen co-operation between member states in order to increase organ availability and enhance the efficiency and accessibility of transplantation systems, while at the same time improving quality and safety. Ireland is prioritising areas for attention from this action plan, particularly those relating to donor co-ordination and public awareness of the benefits of transplantation which will positively impact on organ donor rates. As the need for organs increases, various strategies are being explored in order to increase donation rates. These strategies include the expansion of the criteria for declaring death, increased living donation, opt-out policies and economic incentives. The strategies have the ultimate goal of saving lives and improving the quality of life of transplant recipients. However, all of the strategies are morally debatable and if they are to be pursued, it is important that they do not violate socially accepted ethical norms.

In Ireland, when a potential organ donor is identified, the person's family is asked for consent to allow organ donation to take place. This is known as express consent or an opt-in process to becoming an organ donor. In other words, the decision to become an organ donor rests with the family of the deceased. The programme for Government envisages the introduction of an opt-out system of organ donation with a view to improving the availability of organs for patients in need of transplantation. The introduction of this opt-out system will mean that the consent of an individual to organ donation is deemed or presumed to have been given, unless he or she objected during his or her lifetime. If a person does not wish to become an organ donor after death, he or she will need to register an objection during his or her 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. While the next of kin will not be required to give consent to the donation itself, he or she will be asked to provide as much information as possible on the deceased's medical and social history. I wish to stress there will be no instance where organ donation will proceed against the wishes of the deceased's family. The system to be introduced could, therefore, be described as a soft opt-out system.

The logistics of establishing an opt-out system of consent are complex. A secure IT system must be established and maintained. Hospitals will need to have reliable and continuous access to the latest recorded wishes of potential organ donors. The system will need to define who is responsible for the documentation, who is allowed to enter records and who has access to the information recorded. It will also need to ensure records are valid and correctly assigned. In the absence of a personal unique health identifier, the identification of individuals and the maintenance of a national registry of either potential donors or those who opt out is problematic. An extensive and well resourced communications strategy will be required. Measures will have to be put in place and sustained to protect the rights of vulnerable groups and marginalised members of society.

The Department of Health will commence a consultation process on the introduction of an opt-out system of consent in the next few weeks and will be inviting interested parties to submit their views on the practical aspects of introducing the new system. We will pose a range of questions, allow approximately six weeks for consultation, distil the information received and then organise a focused workshop on the findings of this consultation. The workshop will allow clinicians, Irish donor network representatives arid other relevant parties to give direction to the next steps in terms of the shape of the legislation and what is needed in the health system to implement a soft opt-out system.

The introduction of an opt-out system is an integral element in changing our cultural attitude towards organ donation. We need to make organ donation the norm in Irish society and the default position for those who die in circumstances where donation becomes a possibility. Ireland is among a minority of EU member states, including the United Kingdom, the Netherlands and Germany, that do not have an opt-out system. However, changing the system of consent is just one aspect of a package of measures required to increase organ donation rates. In this regard, the Department of Health, in conjunction with the HSE's national organ donation and transplantation office, is considering what practices and organisational changes, alongside changes to the consent system, could further improve donation rates in this country. The director of that office is working with relevant experts in the HSE and hospitals to develop a plan for the introduction of changes and improvements in donation and transplantation systems and practices in order that as many patients as possible benefit from a proactive and successful programme of organ donation. This includes the identification and deployment of donor co-ordinators in hospitals across the country. The director also regularly interacts with the Irish donor network in order to take account of patients' needs. The Minister for Health has also met representatives of the network and assured them that they will play an active role in shaping policy and actions in this important area.

I support the motion and assure the House the Department of Health will continue to collaborate with the HSE, voluntary organisations and health professionals to raise awareness of organ donation and enhance donation and transplantation rates for both living and deceased donors.

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