Oireachtas Joint and Select Committees
Thursday, 25 April 2013
Joint Oireachtas Committee on Health and Children
Organ Donation: Discussion (Resumed)
We have received apologies from Deputies Catherine Byrne, Regina Doherty and Peter Fitzpatrick.
I remind witnesses, members and those in the public Gallery that their mobile telephones should be turned off rather than in the silent position because they interfere with the broadcasting equipment and it is unfair to members of staff. This morning we are holding the second of three hearings to examine the issue of organ donation in Ireland. I thank all our witnesses for being here and apologise for the short delay in starting due to some private business of the committee.
Members have already received the briefing from the Department of Health and an excellent research paper from the Oireachtas Library and Research Service. I thank the Oireachtas Library and Research Service for the sterling work that it provides to members of the committee and of the Houses. This morning we will hear the medical perspective on the subject from medical professionals working at the coal face of organ donation, and from hospitals around the country. We will also hear from the legal community.
I welcome all the witnesses, Professor David Hickey, Professor Peter Conlon, Dr. James O'Rourke, Dr. Colman O'Loughlin, Dr. Ruairí Dwyer and Dr. Liam Plant. We will be joined shortly by Mr. J.P. McDowell. I thank the witnesses for being here this morning.
Before I commence I remind witnesses about the rules on privilege. Witnesses are protected by absolute privilege in respect of their evidence to the committee. However, if a witness is directed by the committee to cease giving evidence in regard to a particular matter and continues to do so, the witness is entitled thereafter only to a qualified privilege in respect of his evidence. Witnesses are directed that only evidence connected with the subject matter of these proceedings is to be given and are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable. Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official either by name or in such a way as to make him or her identifiable.
With that I call on Professor David Hickey to make the opening remarks.
Dr. David Hickey:
It is nice. I do appreciate it.
I am the director of the national kidney and pancreas transplant programme. This programme is also responsible for organ procurement which is the main topic of discussion today. I have been committed to this programme for 30 years, having personally performed over 1,500 kidney and pancreas transplants and 300 organ procurements. I feel I am in a position to comment at least on my own area which is organ procurement, kidney and pancreas transplant.
The programme started in Jervis Street in 1964 and this year we will complete our 4,000th transplant. This puts the national kidney transplant programme in the top 20 in the world in terms of numbers done. We started only six years after the first successful transplant was done in Boston. We have been at this a long time and I have seen many things happen. Every initiative and advance in this area has been made through the hard work of a few committed individuals. There has never been a national approach to the concept and problems associated with organ donation and kidney transplantation. For example, when we moved to Beaumont in 1987 they forgot that there was a transplant programme moving from Jervis Street and we had to re-jig the urology ward. Essentially that ad hoc concept is how transplantation has been dealt with since.
The main subject of the discussion today is organ procurement. While we need more organ donors I want to emphasise the impact of that on a service that is already stretched beyond its limits in which we are already failing our patients. The numbers waiting are increasing but the numbers being transplanted are not. I will talk about the lack of organ donors, the poor infrastructure in which transplant patients are housed, the shortage of transplant surgeons which is reaching crisis and what I think the ideal for the country should be.
The more donors we have the more organs are available for our patients with end organ failure - liver, kidney, pancreas, heart and lung. There is a global shortage of organs for transplantation, particularly kidneys. It is generally accepted around the world, particularly the western world where this is taken very seriously, that renal failure management is going to bankrupt health services in the next 20 years. I do not know the figures here but in the United States already something like 15% of the health care budget goes on less than 1% of the renal failure patients. With diabetes and end-stage renal failure increasing this will get worse. We need to address this because if we do not we will be talking about rationing dialysis in the not too distant future. That means that there will be no dialysis for people like me or anyone over 60. If one is under a certain age there will be no dialysis. If perhaps one is mentally retarded, or if one is not a valuable member of society, there will be no dialysis and so on. This is a slippery slope and it happens in countries that cannot sustain themselves with transplantation, such as India, Pakistan and Israel, where people go abroad and buy kidneys because there is no alternative apart from dying. While one can have ethical concerns about that, if one has to choose between dying and buying a kidney most people eventually will buy the kidney. That is a slippery slope that is at the end of failure to address this problem while we can still do something.
We have reached a plateau in transplantation in Ireland. We have approximately 18-20 donors per 1 million of the population which up to ten years ago was one of the best rates in Europe. Seeing the coming storm, most European countries have adopted a process of investing in organ donation. It has been done under the concept of presumed consent, the soft opt-out.
The legislation had certain achievements, including bringing transplantation into mainstream discussion at government level in these countries. Most people involved in transplantation travel and know the real advantage is the huge investment in infrastructure at local donating hospital level.
I am sure everyone here knows that presumed consent does not mean a thing. Nobody anywhere in the world takes organs from a child or a person's loved one without seeking the permission of the family. This just does not happen. One can call it what one likes. The presumed consent concept should mean it is presumed anyone looking after a patient who has died offers the family the opportunity to donate. This is an immense consolation to the family. It is a service to a family who has lost a loved one and is not just an organ procurement agency looking to do more business. It offers immense consolation down the line that a young person's family knows that at least, out of a hopeless situation, five people had their lives saved and significantly improved. The other side of the coin is that occasionally we receive letters from families who were not offered this consolation and not asked about organ donation. It is usually out of a perceived kindness as medical personnel wonder how can they possibly bring up this topic at such a time. It is a very delicate area which needs to be examined. The kernel of the problem is that people do not ask because they feel, and justifiably so, that as they have been looking after someone for a while they cannot possibly turn around and ask. I support the concept of soft opt-out presumed consent, but only if it brings organ donation into the main arena and introduces a presumption that everyone wants to do it, and the infrastructure must go in at ground level, which has been the message throughout Europe.
We must address the issue of infrastructure. Hospitals are generally accepted as the location of some of the saddest and happiest moments of our lives. Internationally it is recognised that when it comes to architecture, hospitals should be among the most inspiring public buildings. Every one of us has horror stories and happy stories from hospitals and can empathise with this. The situation in most hospitals is unacceptable for 2013 living. We should examine having something similar to the situation in Norway, a country of 4.6 million people. It has one transplant centre which does six times as many lungs and twice as many kidneys as we do. We must look at this.
The next problem in transplantation is transplant surgeons. No transplant surgeons means no transplant. This is a bigger crisis than the lack of donors for the continuation of transplantation in Ireland. Transplantation surgery cannot recruit young people into training. Anyone we do train goes to the United States the minute he or she can tie a knot because of the opportunities there. It involves night work and weekend work and is not what we call a lifestyle-friendly medical career, which is what many graduates seek nowadays. I will give an example of the impact. Transplant surgeons have the second highest divorce rate among surgeons in the world. Neurosurgeons have a higher rate, mainly because they are neurosurgeons. With transplant surgeons it is because of the lifestyle - they are never there.
Dr. David Hickey:
It is almost as hard as political life.
We should have all organ transplantation and procurement under one roof, as is done in Norway and most of the big European centres. Triplicating services is not a great idea. Consider the expertise that liver can bring to kidney and heart and lung can bring to pancreas. I do not have any idea where such a centre should be, but the issue should be addressed. It is a very cost-effective way of treating people and we should consider it seriously.
We should examine the model in Norway. We should develop a national centre for organ transplantation, and perhaps bone marrow could be included in that, because the personnel involved have a great deal of expertise in infections and immunosuppression. The new national centre should be located in a university hospital, independent of that hospital's board and CEO and answering only to the national organ donation and transplant office of the HSE and the Department of Health. This is essential if we are to stem the tide which is beginning to overflow us. To give an example of how serious the situation is, we have 65 patients who have been fully worked up with their donors for living donor transplantation. These are people who have taken time off work and gone to significant expense to donate a kidney to a loved one. However, we cannot give these people dates for their transplants. At the rate we are transplanting, they will have to wait two and a half to three years to get their living donor transplant. This means that in two years they will have to be re-evaluated and some of the organs concerned will have deteriorated and will no longer be transplantable. A person may have had a blood transfusion and become immunologically incompatible. We risk losing them. The other problem is that these patients are also on the deceased donor list. People who already have a living donor allocated end up getting a deceased donor and taking a kidney off someone else.
I thank the committee for the opportunity to bring our problems to the fore. I have no doubt that in two years' time we will be cutting the ribbon on a brand-new national organ transplant centre which will be a world leader in its field.
Professor Peter Conlon:
I thank the committee for inviting me to speak about organ transplantation in Ireland. I am the clinical director of one of the largest kidney transplant centres in the British Isles and have more than 20 years of experience in kidney transplantation. The views I express are shared by the vast majority of my colleagues in the care of dialysis and transplant patients in Ireland.
Patients with kidney failure have a number of therapeutic options. It is true to say that most patients in the world with kidney failure die without any significant treatment, as the treatment, although effective, is extremely expensive and requires a very sophisticated medical system to deliver it. Patients with kidney failure who have the good fortune to live in Ireland have access to a number of treatment options including peritoneal dialysis, home haemodialysis, in-centre haemodialysis, deceased donor kidney transplantation or live donor transplantation.
Kidney transplantation is without question the best treatment for almost all patients with kidney failure. It provides the best quality of life for patients with kidney failure, more than doubles their life expectancy compared to remaining on dialysis and, in the process, saves the State more than €750,000 over the lifetime of the recipient for each kidney transplant performed. Many patients receiving a live donor kidney transplant can reasonably expect their transplanted organs to function for more than 40 years, which mostly means for the rest of their lives. There are many impediments to delivering more kidney transplants, but the major impediment at present is the availability of suitable donors and the infrastructure to deliver these transplants.
As Professor Hickey described, Ireland has had a successful kidney transplant programme for almost 50 years, but it is nothing like as successful as it could or should be. Ireland should be aspiring to achieve kidney transplantation success similar to that of Norway. Professor Hickey has already described some of the Norwegian experiences. I will compare the two countries in terms of their approach to kidney transplantation. Ireland has a population of 4.6 million, and Norway has a similar population of 4.8 million. Ireland has performed an average of 150 kidney transplants per year over the past ten years, while Norway has performed between 270 and 300 transplants annually. As a result of this difference in kidney transplant activity, Norway has a stable population of 370 patients on maintenance dialysis while Ireland has more than 1,800 patients on dialysis. Ireland could, with appropriate investment, within a few years achieve transplantation results similar to Norway, with enormous benefits to patients with kidney failure in Ireland, and in the process save the State more than €300 million.
The scarcest resource in transplantation is organ donors. Kidney transplantation is almost unique among organ transplantation in that living donors are a major source of organs for successful transplantation. I will first discuss deceased kidney donation.
Organ procurement in Ireland, which is essential for all the disciplines of transplantation - including heart, lung and liver - is run on a shoestring. All organ procurement is run out of an office in Beaumont Hospital staffed by five very committed and professional transplant co-ordinators. These individuals also have many other duties besides organ procurement. There is practically no infrastructure for organ procurement outside Beaumont Hospital in the regional hospitals. The transplant co-ordinators at Beaumont Hospital have developed a network of link nurses in each intensive care unit, ICU, who - in their spare time - assist in educating their colleagues on organ procurement. This is no way to run a transplantation service.
These issues have become all the more urgent in view of the fact that the recently implemented EU directive on organ donation mandates the separation of organ procurement and transplantation and also insists on much more rigorous traceability and organ quality criteria. There is an urgent requirement to establish a formal national organ procurement agency, which would provide a national resource to every ICU and emergency room in the country, namely, expertise in organ procurement. As already stated, Ireland has five transplant co-ordinators. Northern Ireland, with a population less than half the size of the Republic's, has 27 and in the UK there are more than 200. When the UK recently implemented an investment in organ procurement, there was a 50% increase in organ donations. Implementing resources to properly manage organ donation is far more important than implementing a presumed consent law and is likely to result in a far more dramatic increase in organ donation.
Living donor kidney transplantation is also an important process in treating kidney failure and delivers far better long-term results than deceased kidney transplantation. I am pleased to inform members that the Department of Health and the HSE have recently committed funding to deliver the first phase of a very significant expansion in live kidney donation and have agreed, in principle, to fund a plan which, it is hoped, will deliver during the next three years 100 living kidney donation operations annually. This plan has been stymied at every turn and has not yet been implemented. I am unsure when it will be implemented, despite the urgent need that exists. There are currently almost 100 kidney donor-recipient pairs awaiting living kidney donation in Ireland.
There are, however, a number of very important other issues that need to be urgently addressed if Ireland is to realise the full potential of living kidney donation. In this regard, the implementation of the human tissue Bill will be necessary to deliver on the relevant targets. The first of the issues to which I refer relates to coverage of the out-of-pocket expenses of living kidney donors. Each living kidney donor saves the State more than €750,000 euros in health care costs. Currently, however, a living donor pays all expenses relating to travel to and from the hospital, extra child care costs, etc. Typically, a living donor will require several weeks off work following such major surgery and thus will not be available for work. It typically costs each living kidney donor between €5,000 and €7,000 in lost income and out-of-pocket expenses. It is common practice in most developed countries for health authorities to cover out-of-pocket expenses for living kidney donors. In the UK, the state covers up to £5,000 in such expenses. The EU directive requires the Minister for Health to implement such a system. I urge him to implement it without further delay. It is unfair that not only does a living kidney donor gives up one of his kidneys but that it also costs him so much money in lost income.
I am aware of at least two Irish individuals who wanted to become altruistic kidney donors. Such donors are people who recognise that there is a major need in respect of those with kidney failure and offer to donate one of their own kidneys to individuals they do not know. As a result of the lack of legislation permitting such donation in this country, it is not yet possible. The two altruistic donors to whom I refer donated their kidneys to people in the UK because it was not possible to donate in Ireland. This means that two kidneys were lost to Irish patients forever. Human tissue legislation would be necessary in order to legalise altruistic kidney donations here.
Patients with a donor who is incompatible due to a blood group or tissue type mismatch can now frequently find a compatible donor by way of a paired kidney exchange programme. We have recently developed a relationship with NHS Blood and Transplant in the UK for the sharing of living human kidneys as part of the implementation of a paired kidney exchange system. This will allow large numbers of Irish and UK patients to receive live donor transplants that would not otherwise be possible. In order to implement the paired kidney exchange scheme with the UK, the Government or one of its agencies will be required to enter into a service level agreement with the UK transplant authority.
A significant number of patients living in Ireland and receiving kidney treatment here have relatives abroad who would like to come to Ireland and donate a kidney to their loved ones. There is currently no clear-cut mechanism or policy from the Department of Health to allow these donors to come to Ireland and receive care in Irish hospital and health care institutions in order to facilitate organ donation here.
The Road Safety Authority, by way of its hard-hitting public awareness campaigns, has transformed people's view of road safety. I am of the view that a level of resources similar to that employed in respect of road safety campaigns should be invested in promoting organ donation awareness among the general public.
Transplant surgery commonly occurs in the early hours of the morning and is consequently arduous. If a transplant programme is to be successful, the system needs to ensure there is an ongoing supply of these highly skilled professionals. I refer, in particular, to transplant surgeons, whose training typically takes 15 years to complete. Failure to implement the working time directive and bans on recruitment have put this essential resource in peril.
As somebody who each day witnesses the fantastic life-saving and life-changing benefits that organ transplantation brings to the Irish population, I would support any proposal that would ethically allow for the expansion of this technology in this country. I am of the opinion that introducing a presumed consent law would have very little impact in expanding organ transplantation and should not be at the top of our priority list. Rather, we must focus on the reorganisation of organ procurement services to ensure that every potential organ donor, whether living or deceased, is identified and facilitated in order that successful transplantations can take place. There is also an urgent need to implement the planned expansion of transplantation infrastructure at Beaumont Hospital to ensure that all live and deceased kidney transplants can be performed to a high standard and without delay.
Dr. Ruairí Dwyer:
I am Ruairí Dwyer and I am a consultant in the ICU in Beaumont Hospital. I have been involved with identifying and obtaining consent for transplantation there. In that context, I work in close collaboration with the organ procurement service run by Ms Phyllis Cunningham, who came before the committee last week. I am chairman of the committee on organ donation of the Intensive Care Society of Ireland, ICSI. The ICSI represents doctors who work in intensive care medicine. Our committee and organisation include representatives of nurses who work in ICUs and organ donor co-ordinators. We emphasise the importance of links with ICU nursing in respect of this issue. As intensive care consultants, we are the clinicians who are directly responsible for the care of all patients with serious brain injuries and the diagnosis of death in those patients who unfortunately progress to brain death. We are involved in explaining organ donation and in requesting permission from families for such donations. We are also involved in the care of organ donors in order to optimise the number of organs suitable for transplantation.
Promotion of organ donation is seen as being an integral part of our job if our efforts to preserve life have failed. There is strong enthusiasm in ICUs on the part of both medical and nursing staff. Education in organ donation issues is an integral part of the training relating to our specialty. This education remains ongoing throughout our careers. The ICSI held a day-long conference devoted to organ donation in 2012. This attracted a large attendance of both medical and nursing staff who work in intensive care. The ICSI has published guidelines on the diagnosis of brain death and on organ donor management in order to help increase the number of organs available for transplantation. With support from the HSE, intensive care clinicians are establishing an audit programme which will encompass a comprehensive audit of organ donation within ICU and which will identify any potential for improvements in this area.
We believe that our specialty has made a significant contribution to the relatively high rate of organ donation in Ireland. However, we see major challenges in increasing the rates of organ donation and even in maintaining current rates of organ donation. I work in the neurosurgical centre in Beaumont Hospital. When I started 20 years ago we had a brain death diagnosed probably once a week but now we have such a diagnosis once or twice a month. That is the pool we are recruiting from for organ donors.
We strongly support the proposals from Professor Egan, which have been mentioned by the two previous speakers, for promoting public awareness, for increased numbers of organ donor co-ordinators and for the appointment of staff in each hospital network with responsibility for promoting organ donation. There are differing opinions within our specialty on presumed consent. Many are concerned that presumed consent could lead to a decrease in organ donation if the concept of organ donation as a voluntary gift is replaced by a perception of compulsion. Others, however, feel that presumed consent would have a positive effect on organ donation numbers. On balance, that is my position. I will return to that at the end of the statement.
Our society was unanimous that whatever legislation is introduced, the practical details of its implementation will be vital in ensuring that current levels of consent to organ donation are maintained. We are the group who will be asked to implement any new legislation and we hope it will be drafted to ensure there are no accidental obstacles to organ donation in it. Issues of concern to us include how the issue of consent to organ donation will be addressed in practical terms. We must examine what will happen if no relatives are available to provide consent and whether presumed consent would apply to donors after cardiac death, which are a different group to donors after brain death. There is need to have a secure register for those who wish to opt out of organ donation before death, if presumed consent was introduced. We suggest it would be vital to have close collaboration with the clinicians on the ground who work in ICU in drafting any legislation or regulations for its implementation.
We are delighted with the amount of attention being given to organ donation and with the level of commitment of this committee in addressing the issue. Organ transplantation transforms the lives of patients and it will be a very positive achievement for society as a whole if we can maximise the number of patients who benefit from it.
To return to the issue of presumed consent, we canvassed opinion within intensive care medicine. A fairly significant majority was opposed on the basis that it could have the opposite effect to what is intended. That is something on which my colleagues will elaborate. On balance, I feel it would have a positive effect in terms of changing the terms on which we approach patients for organ donation, in making organ donation the norm rather than the opt-in position. Most importantly, when one looks at the evidence that is available from countries that have introduced presumed consent, it seems to be associated with a small but significant increase in organ donation, provided it is linked with improvements in resources, in particular improvements in staff who are aligned with organ donor co-ordination services.
Dr. Colman O'Loughlin:
I will be brief. What I want to do is drill down a little into what Dr. Dwyer has mentioned. I also represent the Intensive Care Society of Ireland, which in turn represents the consultants working in intensive care medicine throughout the country. The committee has a copy of our position statement on presumed consent addressed to the Minister. Our position is that we favour staying as we are with an opt-in situation. That was not a unanimous position. It was a majority decision. Dr. Dwyer explained that many people had different views.
Dr. Colman O'Loughlin:
What I will do is drill down a little deeper into what we do as intensivists and why the views of the Intensive Care Society of Ireland on organ donation should carry a lot of weight. The majority of organs donated in this country are donated from brain-dead donors. The care of those patients occurs in intensive care units. Brain death occurs in intensive care after a significant brain injury where a person is on a life-support machine. The staff involved include the intensive care specialist, the nursing team and our trainees. It is our job to care for those patients. Our primary duty of care is to the patients and, by extension, to their families. Sometimes a brain injury progresses onto brain death. That is a clinical diagnosis that we must make at the bedside. We do two sets of brain stem tests. They are identical tests done by two separate groups of people separated by a brief period of time. Our job is to do the tests, the first, to determine brain death, and the second to confirm that at a later stage.
It is between the two sets of brain stem tests that we approach the family of the patient and bring up the issue of organ donation. How we do that is very important. It will be obvious to everyone that this is a period of extreme trauma for the family. There will be overwhelming grief, a lot of confusion, anger and a huge amount of tension among family members because these types of events happen, by and large, to young people and they happen very suddenly. One has to imagine what it is like to deal with these scenarios, the patients and their families. When we engage with them on the issue of organ donation it is very important that we do it delicately with a lot of compassion and empathy. How we say it and how we bring it up is extremely important. We are advocates for the patients and, thereby, their families. We do not have any say in who is on a waiting list for organ transplantation. We have no idea of what is happening on that end. We are on one end only. In these circumstances, we do not ask them to be organ donors or we do not ask them not to be organ donors, we give them the opportunity to consider organ donation. We do not necessarily ask for an answer straight away.
What we normally do is go back and do the second set of brain stem tests to confirm brain death. Time of death will be at the conclusion of the second set of brain stem tests. At this stage we will go back to the family and re-engage with them and ask for their opinion on the topic of organ donation. We will have families come back to us and say “Yes”, that for many years they have talked about it and it is something that they as a family and their deceased relative really supported for many years, and that they would like to consent to the process of organ donation. To that family I say, “Thank you for considering this. You have done the right thing for you, your family and your deceased relative.” Alternatively, the family might come and say they are not sure, that they have talked about it and they have never been easy with the concept, that they are not comfortable with it and not really keen to consent to organ donation. To that family I say, “Thank you for considering it. You have done the right thing for you, your family, and the deceased relative.”
What I am trying to say is that there is no right answer, there is no wrong answer. There is only the answer that is given to me by the family. I have to accept it. I have to remain and continue to remain neutral in the process. My duty of care is to the patient in the bed and his or her family and to no one else. I have to be really neutral. One might ask why I do not lobby for transplantation. I do not for the same reason that I cannot lobby against it. I have to be neutral. I can raise the question. Dr. Hickey explained the matter eloquently. My job is to ensure that in every single incident that brain death occurs in this country, the question is asked to the family to give them the option. Not to give the option is a dereliction of care from a societal point of view. I cannot sway their opinion either way but I have to give people the option. The role of the Intensive Care Society of Ireland in that is to make sure that this happens; to educate our colleagues and to provide resources and training for them so that they are aware of how brain death occurs, that they test for it properly and that they are given the proper skills to deal with the families, help them to come to terms with what is happening and to phrase the issue of organ donation in a neutral, empathic manner.
That is really what I want to say and I want to set the scene as to why and how this happens every single day, separate from the transplantation issue. I have reservations about presumed consent, largely because, as echoed by our transplant colleagues, I do not think it will make a huge difference. I go back to what I said about how we interact with a family and where I could bring presumed consent into the conversation. I am not going to change my style of conversation with the family, regardless of what comes out of this process because that is what is practised throughout the world and that is the recognised way of trying to deal with this delicate scenario with traumatised families.
Consequently, I do not see it as a huge issue but as being way down the list.
I will not go through all of the resource allocations required as that issue has been eloquently discussed this morning. However, from the perspective of consent, it is not the big issue. It is not the big ticket and I do not think changing this will make any difference. What really will make a difference is increasing resources and infrastructure.
Dr. James O'Rourke:
I promise to be brief. I thank the joint committee for its invitation to speak today.
Mr. Hickey has devoted his whole life to transplantation and if anyone deserves to be a professor, it is him for sure and I mean that sincerely. He has alluded to the entire spectrum of organ donation, from the time an organ comes from the donor patient to when it is transplanted into the recipient patient, where it goes and the circumstances involved, as well as the resources and funding available at each stage. My colleague, Dr. Dwyer, and I work together in the intensive care unit of Beaumont Hospital. Both of us care for patients with neurocritical injuries - traumatic brain injuries or intracranial haemorrhages. In his presentation Dr. Dwyer alludes to the fact that when we started 20 years ago, we used to carry out brainstem tests perhaps once a week. Certainly, the demographic of patients we see is testimony to the success of the Road Safety Authority. As members are aware, in 1998 approximately 400 people were killed on the roads, whereas in 2012, approximately 160 people died. Organ donation rates mirror exactly road fatality rates. Clearly, the number of people killed will also reflect the number who experience catastrophic injuries, which is testimony to the success of the Road Safety Authority and its laudable work in recent years.
Essentially, the pool of potential organ donors has decreased. As to what should be done about this, my colleagues have suggested and I strongly concur that we must never miss an opportunity where there is the potential for organ donation. However, we lack infrastructure that could facilitate this process. I will speak a little about that issue. The other aspect is that we must look a little more widely in the field. My own area of specialist interest is donation after determination of death by cardiovascular criteria, also known as donation after cardiac death, DCD, or non-heart beating donation. This is an area in which I am very interested and which in a way mirrors donation after brainstem death, DBD. They are similar in a way, in pertaining to deceased donation.
I will read briefly from my statement. On the proposed changes to the current opt-in system of legislation, I support fully the position taken by the Intensive Care Society of Ireland in stating the majority of its members oppose changes to current legislation. This opinion has not changed since the previous submission made in 2009. Members will be aware that in that public consultation document the opinion of 23 of 30 learned organisations canvassed on the topic was against a presumed consent model. This is my personal opinion and we are all on the same page, in that no one will argue that to receive an organ transplant is a life-saving procedure. For my part, as an intensive care clinician, I am very committed and believe it to be the gift of life. However, nothing can ever be presumed in a gift and nothing should be taken for granted. We rely on public trust and confidence in the medical profession and it would only require a single case to go wrong or blown up in the newspapers for such trust to be damaged. Were the public to be led to believe doctors are now entitled to take organs, unless they have signed up to an opt-out register of some kind, this could be counter-productive overall. In my submission I state further that in 2010 Ireland ranked ninth out of 27 countries in our rates of organ donations, at 17 per million of population. That is not bad if one thinks that among the European Union of 27 member states Ireland ranks ninth. While that is okay, we run a long way behind Spain where there is a rate of 30 organ donors per million of population.
The rest of my submission relates to the subject about which Mr. Hickey and Professor Conlon have spoken, with a little bit drawn from my own area of intensive care, essentially on resourcing the donor transplant co-ordinators and providing more level 3 clinical intensive care beds. I am very proud to work in Beaumont Hospital which is a great institution. When I qualified there in 1995, we had 20 intensive care beds, whereas today we have 17. The population has not become smaller and one must now be pretty sick to get into the intensive care unit in Beaumont Hospital. As a result, while we would like to give everyone the opportunity and facilitate organ donation, where possible, one's bed is not cold in Beaumont Hospital before someone else is in it. That is a fact. The resourcing of intensive care beds is an important component of organ donation. Families should be given the opportunity, where possible, to enable their loved ones to become organ donors. However, as often happens in the triage of patients, in a case in which one patient has been critically injured and will not survive and someone else is arriving in casualty who is gasping for breath, one will always take the patient gasping for breath because he or she has a chance of living. However, resourcing intensive care units and providing high level intensive care beds should be a key priority. Beyond this, from my perspective, I can only echo what Mr. Hickey and Professor Conlon said.
While I accept that the medical literature shows a positive slant where presumed consent has been introduced, this is somewhat clouded by turning the camera on organ donation for a short period of time and increasing public awareness. The increased organ donor numbers seen where presumed consent was introduced may be a reflection of this, that is, a reflection of increased infrastructural investment in the area.
The new driving licences are great, as they are little cards that allow for a code 15 regarding organ donation to be included. Personally, it should be more like the American model and more explicit. It should be a mandated request on documentation for passports or driving licences. I am also in favour of requiring a request in order that each patient or each family can be given the opportunity to donate organs, if there is potential for organ donation.
I thank Dr. O'Rourke. The next speaker is Dr. Liam Plant who is the national clinical director of the HSE's national renal office, as well as being a consultant physician in Cork University Hospital.
Dr. Liam Plant:
I might add two points of information on numbers which might inform the joint committee which I thank for its invitation. I work as a consultant renal physician at Cork University Hospital. Between 2003 and 2009, I acted as chair of the national strategic review of renal services.
Since March 2009, I have been the national clinical director of the HSE national renal office. The national renal office is responsible for planning, co-ordinating and managing the strategic framework of renal services across the country. Prior to 2001, I worked as a consultant renal physician at the Royal Infirmary of Edinburgh and was involved in the organisation, co-ordination and delivery of renal and transplant services in that country.
As has already been said, in common with all countries, the number of our fellow citizens affected by permanent kidney failure, a term which, as the committee will have heard, is technically described, perhaps rather unpleasantly, as end-stage kidney diseases, ESKD - it merely means that one's kidneys are permanently failed and one either needs dialysis or a transplant - continues to grow. The national renal office conducts an annual census of this on 31 December each year. On 31 December 2012 - this is in part answer to a question the Chairman posed to the Minister on 5 March last - just under 4,000 of our fellow citizens had end-stage kidney disease, 81 being children under the age of 18. Of the 3,876 adults with end-stage kidney disease, 1,560 or 40% of the total received treatment by haemodialysis at a number or haemodialysis units dispersed around the country. Some 237 or 6% of the total were treated by one of the forms of home haemodialysis or home dialysis - there are different forms - in their own homes. Thankfully, and I would echo what has been stated already that this is a testament to the existing success of the renal transplant programme in Ireland, 2,079 or 54% of the total already have a functioning kidney transplant, and 62% of children with end-stage kidney disease currently have a kidney transplant.
It is important to stress that whereas all types of renal replacement therapy are successful treatments for end-stage kidney disease, prolonging survival, improving functional status and allowing patients to carry on with their lives, there is no doubt that kidney transplantation is the best of these options. I will not reiterate what has been said on this already. It is the policy of the national renal office that strategic planning should seek to maximise the number of patients who can avail of this and whereas not all patients may be suitable as recipients of a kidney transplant, many more than have currently received one are so and this is reflected in the waiting list for transplantation.
As well as being a considerable physical, social and psychological burden on patients with end-stage kidney disease treated by any of the forms of dialysis therapy, the costs to the State of providing these therapies are very substantial. In 2011, the ESRI noted - the reference is given as "Activity in Acute Public Hospitals, Annual Report 2010" - that the single highest-ranked procedure for day patient attendances at acute public hospitals was haemodialysis and that accounted for one fifth of all day-case attendances. In 2012, we delivered just under 250,000 haemodialysis procedures in Ireland. Another metric which many may find compelling is that last year, with a careful mapping exercise, we identified that Irish patients who travel to and from dialysis - one must remember they go 156 times a year - travelled 13.5 million km in 2012, and the State provides a degree of subsidy to this.
Despite reductions in the unit costs of these treatments over the past few years, they continue to generate very substantial revenue charges. Professor Hickey referred to those numbers. The best estimate that our office could make on the cost of this would be as follows. We believe that the attributable costs for dialysis, excluding support for transplant and certain drugs, comes to approximately €91 million for haemodialysis and approximately €7 million for home therapies. If a patient is transplanted, he or she will also be on transplant drugs which would cost roughly the same as the other drugs they are on. Effectively, just under €100 million is the cost of the dialysis therapies for 1,800 of our fellow citizens.
In the five years since 2007, the number of adults with ESKD has increased by 24%. That is an absolute increase of 743 patients. Of this increase, 63% has been accounted for by an increase in the number of those with a functioning transplant - that number being 466 - with the remaining increase due to an increase in those treated by dialysis - 277.
The second point of information is that we are very comfortable in modelling the likely future growth in end-stage kidney disease. Based upon what has happened previously and what we would anticipate in the future - one must remember that the growth in the number of persons at the end of every year with end-stage kidney disease is the sum of new patients who start for the first time minus those patients who, regrettably, pass away and how they are distributed depends upon dialysis - we would project that every year we will have between 114 and 178 additional end-stage kidney disease patients in the Republic of Ireland. If I take the mid-point of that which is 150, and if there is no additional transplantation, that means that every year we will have to open a new haemodialysis unit the size of Cork University Hospital dialysis unit, which is the second largest in the State. If transplantation rates go up, that proportion that will go up will obviously diminish.
There is, therefore, echoing what others stated, little doubt but that an increase in access to organs suitable for transplantation would improve the survival, rehabilitation and quality of life of many more patients with ESKD than at present. Furthermore, the potential future costs of dialysis therapies that would be forgone - these would not be savings we would now make but future costs we would avoid - would benefit the renal programme, the health services as a whole and the Irish taxpayer.
The principal question that needs to be addressed and is being addressed by this committee is "how is this best achieved?". A variety of potential solutions have been advanced by a variety of individuals, organisations and healthcare systems. I am happy to offer my own observations on those elements that I think are likely to increase transplantation while at the same time, as has been mentioned, preserving the confidence of the wider citizenry in the organisation of this activity.
Undoubtedly, increasing the resources available to support living-donor transplantation is a key element, but what of deceased-donor transplantation? As has been highlighted in a 2009 United Kingdom health technology assessment, a number of elements contribute to the variation rates of organ donation between countries. These include: the national wealth and investment made in health care services; the legislative framework that underpins donation, particularly as this applies to questions of presumed or informed consent; the availability of potential donors - comment has been made about variations, thankfully, in road traffic deaths and other issues; public attitudes to, knowledge of and education about organ donation and transplantation; and, critically, the organisation and infrastructure provided to deliver organ donation and transplantation. Much of the commentary has focused on legislative framework which is of extreme importance. However, I would strongly associate myself with the views expressed by others that in the absence of a robust organisation and infrastructure to support this endeavour, any legislative framework is unlikely to achieve its maximum potential in increasing donation. Similarly, robust engagement with the public to minimise anxiety, misunderstanding and fear regarding any potential legislative change must also be of the highest importance.
I thank Dr. Plant. The final speaker in this session is Mr. J. P. McDowell, partner in McDowell Purcell Solicitors, giving a legal perspective. I thank him for coming in at short notice. We appreciate his flexibility in being here this morning.
Mr. J. P. McDowell:
I apologise for not circulating them in advance.
I listened carefully to the medical practitioners who have given evidence to the committee and I am grateful for the opportunity to address the committee. Listening to the evidence that has been given, it seems that the concern and focus of the medical community at the very least is possibly not around the issue of opt-in or opt-out and presumed consent, but more around the issue of what legislation can bring in terms of infrastructure and resources.
When preparing for this, I was struck by what the CEO of the Spanish transplant authority stated recently about the early years of opt-in in Spain. He made the point that in the first ten years of the presumed consent or opt-out structure in Spain during the period leading up to 1979, the opt-out structure introduced by legislation there did not increase rates of donation significantly.
He was making the point that increased rates of donation represented the introduction of expert liaison personnel or transplant coordinators throughout the intensive care units around the hospital network, and that the opt-out or presumed consent system, in itself, was not necessarily contributing to increased rates of donation. That possibly touches on some of the issues highlighted by the medical practitioners who have already given evidence. Regulation 22, within the recent statutory instrument, is the current legal background. That follows the directive. The directive itself does not compel member states to introduce one system or another but it compels them to address the issue of consent. That is exactly what this member state has done. It has issued a statutory instrument in which the issue of consent has been addressed. Consent is required from the next of kin of the deceased at present.
As I understand it, there is a framework to be introduced by the HSE. We are awaiting its publication. This committee is now interested in considering whether presumed consent is ethically and legally robust and whether it is potentially challengeable. Throughout the 30 years in which presumed consent has been introduced in various member states, there has been no challenge to it or an opt-out system. I refer to a challenge on the basis of the convention. The committee may be aware that the European convention provides for a number of rights that might provide the basis of a challenge to a presumed consent system. One is Article 8, which establishes the right to a private and family life, and another is Article 9, which pertains to the freedom of conscience and religion. We also have constitutional rights, which would have to be observed in any legislative structure. We have Article 40.3.1°, the right to bodily integrity, Article 44, the right to freedom of conscience and religion, and Article 41, which recognises the family as a fundamental unit. These rights are all relevant in this territory.
I am not quite certain from a legal perspective whether there is a significant difference between an opt-in system and an opt-out system in terms of whether the underpinning legislation is legally fragile or robust. The key would seem to be the extent to which the consent of the family members of the deceased is being sought. The further one drifts away from that principle, be it through an opt-out or opt-in arrangement, the more fragile the structure becomes, not only for reasons associated with the convention or the Constitution but also for reasons that underpin medical practice. The whole concept of medical practice is based on one of the central tenets of informed consent. Thus, if one moves to an opt-in or opt-out system that takes the rights, needs and decisions of the family away and establishes a right to veto its decisions or views, for example, it begins to sit uncomfortably with the tenet of consent that underpins medical practice.
At its centre, this debate is about consent. I am not quite sure whether presumed consent is necessarily going to increase the figures on donation. Some of the evidence would suggest that it may do so marginally but perhaps it will not do so at all. One of the key concerns must be about the issue of medical practitioners and protecting them. A key aspect of any legislation introduced should be to set out the consent process clearly. In the United Kingdom, for example, the Human Tissue Act goes through a system of defining qualifying relationships in terms of next of kin and it stipulates people who must be consulted. Underneath that, it introduces codes of practice that provide another layer of detail on what is required. That would probably be envisaged in the legislation that may be introduced.
In one sense, the issue of presumed consent may well provide a positive context or starting point for a conversation between a medical practitioner and the deceased's relatives in an intensive care unit. That may well be positive. However, from a legal perspective, I am not certain whether it is important that there be an opt-in or opt-out arrangement, but the key is to note that the further one drifts away from the issue of consent from relatives, the more potentially challengeable or fragile any legislative structure becomes.
That is a summary of my views on some of the legal implications flowing from an opt-in or opt-out system. There is further detail in the document that has been circulated. I will be happy to answer questions.
I welcome all the presentations. We had the same discussion last week. While there may be varying views on how we approach this issue, it is important that organ donation be encouraged and facilitated, where possible. Many steps need to be taken.
Dr. Plant implied that we can profile the challenges that will be faced in the years ahead in the context of kidney failure and other conditions requiring transplantation. It is quite obvious that there will be difficulties associated with transplant surgeons. Perhaps talking about organ donation in isolation without promoting infrastructure and its development would mean the committee would be failing in its responsibility. Clearly, it is not just a case of organ donation; it is also a question of infrastructure and having personnel trained to approach families.
Does the doctor who was treating the patient who suffered from brain or cardiac death approach the family? Is that normally the case or is there a specialist nurse or staff member who has experience and training in approaching families with regard to organ donation? Does it happen on an ad hoc basis or are there structures and protocols in place? Does it depend on the consultant, surgeon or doctor?
I once encountered a family which lost a loved one and which was too traumatised in its grief to think of organ donation. The family has regretted it since. There are organs available every week that could be used but which are not used. We do not know why. We do not know whether there are cultural issues at play or whether we just do not profile, highlight and encourage organ donation enough. We do not know whether there is sufficient infrastructure in place. Much discussion needs to be held, not only on the legislative side. We must really promote the concept at Government level and throughout broader society.
When one sees the progress made in regard to the national paediatric centre, I have great confidence that action on the national transplant centre, on which I welcome the views, will happen very quickly.
As regards all-island based transplantation and harvesting, and on an east-west basis, is there a greater capacity for us? We are a small nation with limited resources so can we pool them on an all-island basis, in a structured way, including between Britain and Ireland? Surely there must be greater scope and potential to pool our resources in that area. In the coming years with the difficulties in which the State finds itself, I do not believe that the longer-term planning needed in the context of training transplant surgeons and other investments in infrastructure will happen as quickly as we would like. Therefore, there is the potential for co-operation in that area.
We are witnessing an international trade in organs, which is both illegal and unethical. It is disturbing and emanates from Latin America, Asia and parts of Africa. Clearly, the West is encouraging organ donation in whatever guise, be it soft consent, informed consent or opt-out. By encouraging people to donate organs it will surely assist in reducing the illegal trade. One would hope that is the case, although it may not be. As parliamentarians, we can do many things nationally and internationally in the European context.
I am intrigued how the system works at the coalface. For instance, in a hopeless case when all chances of survival are gone, who approaches the next of kin or is it done on an ad hocbasis?
I joint with the Chairman and other colleagues in welcoming each of the contributors. Like so much in life and death, this is not a straightforward issue by any measure. Dr. O'Rourke talked about the one-page system. It must be acknowledged that, irrespective of the different views on presumption or signing up, everybody is sincerely working towards the objective of improved donor availability and the consequent access for those in need. It is a matter of trying to find the appropriate response.
I would like to ask a few additional questions. Both Dr. Hickey and Professor Conlon referred to the Norwegian model. As regards the number of transplant surgeons, I note that in the third page of his presentation, Dr. Hickey spoke of a current situation involving four whole-time equivalents. Is that the actual number currently in situ for the kidney service, or is it the picture across the board? He indicated that if we were to exercise the European Working-Time Directive we would need 20 transplant surgeons to run our current service. Will he clarify if that is particular to the kidney transplant area or does it cover all transplant issues that arise?
I am taken with Dr. Hickey's argument for a single centre of excellence and expertise that would cover all the various areas of need. I note that we currently have a triplication of such facilities in Ireland, which obviously does not allow for that professional engagement on a continuous basis and all the other advantages that would occur.
I thank the witnesses for what they have said. At the end of the day, even if the presumed approach were to be legislated for, could the current capacity cope even if there was a significant increase? Clearly, that remains a matter for debate among Dr. Hickey and his colleagues. From what I can ascertain from what he and others have said, they simply could not cope with a significant increase in availability.
Professor Conlon referred to establishing a national organ procurement agency. I know that there are representatives of the procurement end of this who have made important and useful contributions. I cannot fail to note that we have only five transplant co-ordinators here - a fact which, compared to the figures in Northern Ireland and Britain, jumps off the page at me.
Professor Conlon indicated that the proper management of organ donation would have a greater impact and a more dramatic increase in organ availability than even the presumed idea that is coming into play. I understand the concerns outlined by Dr. Dwyer and his colleagues that presumed consent could lead to a decrease in organ donation. I am not so sure that would be the case, however. It would be alarming if it were. In that respect, it would offer a break in the current enthusiasm for the presumed approach which was well described here last week by a range of people, including living donors and recipients who gave powerful testimony. One young woman, just five weeks after a kidney donation, looked in better health than any of us gathered here today. It was wonderful.
Dr. O'Loughlin referred to a number of measures that should be taken to have a more certain outcome than the presumed approach. Is Dr. Hickey's view on a single centre of excellence shared across the board? The Intensive Care Society of Ireland's correspondence to the Minister speaks of particular measures but I presume they are only in the context of the current trilocation of activity.
Dr. Plant strongly emphasised that the organisation and infrastructure provided to deliver organ donation and transplant services is a more certain requirement now and with more definite positive outcomes.
I thank each of the witnesses for their respective contributions. The well-intentioned, non-professional case that is being presented by people like Mr. Brolly and others who have taken up this issue, is gaining significant momentum. It will have the support of influential organisations and other interests in the coming week. I am aware that this matter will be addressed further then. The contributions we have heard are timely and welcome. I thank the witnesses for them. When the Chair allows it, perhaps they can respond to the questions I have posed.
I welcome my fellow professional colleagues here today. Their illustrative, illuminating, educational, informative and humane presentations have gone to the heart of some of the most difficult interactions that doctors have with patients and their families. It is not all that long ago that I used to find myself occasionally having this conversation with relatives. It is one of the most difficult areas.
I would like to pay particular tribute to Professor Hickey who has been an extraordinarily wonderful role model for young Irish doctors in terms of his devotion to this cause over the years and for keeping it on the agenda where it should be.
The problems of transplantation are contributed to partly by the organ crisis. I am delighted that so many of our colleagues have correctly and forthrightly pointed out that one of the major problems is also resourcing. There is no doubt that this is a microcosm of the health service in general and its problems. Unfortunately, we have a system which is under-resourced, grotesquely understaffed and mismanaged by people who should not be managing it. The people who should be managing the service are being relegated to the status of clinical technicians by a group of people who should not be making the relevant decisions. The system is not underfunded, but it is severely malfunded and requires reform. Professor Hickey's apocalyptic scenario involving the rationing of dialysis should not be dismissed as a Cormac McCarthy-like future fiction. The inexplicably widely-loved NHS in the United Kingdom was doing this until comparatively recently. Certainly, in my professional memory, middle-aged patients were systematically denied dialysis in certain regions as it was felt the system could not support them.
I am 100% in favour of Professor Hickey's suggestion that we should have a solitary national transplant centre. While much of my criticism is aimed at bureaucracy, there is a certain amount to be laid at the door of doctors and medical-school politics. Norway has a slightly larger population than Ireland and has four medical schools. There is only one medical school in Oslo, while Dublin, with a smaller population, has six medical schools. We have one medical school per 750,000 inhabitants, whereas the European average is one per 1.5 million. The average in the United States of America is one school per 1.2 million people. One cannot have rational structures when one disperses one's resources across an irrational number of centres, which are kept alive for the benefit of powerful medical-political and academic forces with a vested interest in maintaining them. It is an issue we must discuss, albeit in another forum.
Professor Hickey, Dr. Conlon and Dr. Plant are perhaps best placed to assist me on the following. As a general rule of thumb, the number of specialists per capitain Ireland is approximately 80% of the number in the UK, while the UK has approximately one third of the number which is the norm in continental Europe. In turn, the number in continental Europe is substantially lower than in North America. Do the three witnesses know roughly what our figures are and how we compare? I suspect that by European standards we are grotesquely under-provided not only with transplant surgeons but with nephrologists, if only somewhat under-provided by UK standards. Is that a fair characterisation?
I thank all the contributors for their excellent presentations this morning. I have learned a great deal from them. Has there been any discussion of providing one transplant unit for the country among the medical profession, the HSE and the Department of Health? The need for a long-term plan has been highlighted. I have a serious problem with the way the HSE is dealing with the general doctor issue at the moment. We seem to be going from year to year rather than planning for the long term. I wonder if those involved in this area have worked to set out a ten-year plan with clear targets and if that includes the creation of a single unit. We are dealing in many areas nationally with reconfiguration of the service. Has the creation of a single transplant unit been part of the discussion process on such reconfiguration?
If the problem of organ donors and the availability of space to carry out the work were resolved in the morning, what would the system's maximum transplant capacity be? Professor Hickey said we should aim to carry out 300 transplants per annum. If we resolved all the other issues, how long would it take to reach that target and how many additional consultants and beds would be required? What is the maximum number of transplants that could be carried out with the current capacity in the system if we had all the necessary organ donors and theatre and bed space? It is important to identify at this stage where we are at and what we can deal with.
I welcome the witnesses and thank them for their very interesting presentations, which follow on from those given last week. It was lovely last week to hear emotional stories from live donors and to see recipients and how they benefited.
I read some of the opening statements last night and was struck by how little I knew. I did not know that Ireland did not have a specific transplant centre and a faced a serious lack of transplant surgeons into the future. I learned that the programme is run from an office in Beaumont Hospital and has only five co-ordinators, who have other duties to attend to. I had thought we were much further along than that. We seem to be very behind the times. I was also struck by the huge size of the investment required in the system even if we had the donors. I was also struck that a living donor had to pay for his or her own expenses, which are of the order of €5,000 to €7,000. While that is a small amount of money given the return, many people will find they cannot afford those sums. We must be living in the Dark Ages to expect people to do that. I was further struck by the fact that we do not have legislation to cover the scenario in which a person wants to donate an organ and the donor must therefore travel abroad in order to donate.
Most of the questions I wished to raise have been dealt with by other speakers. I thank the witnesses for their contributions. They were a real eye-opener and very informative. I agree 100% that we must apply resources to making people more aware of the organ donor programme and to encouraging donations. As I said, I am a member of the health committee and the presentations have been a significant eye-opener.
I would love to say there was a pot of gold at the end of the rainbow into which we could dig to build facilities and assist people who want to be live donors. Unfortunately, there is not. I do not know what the last Administration was doing here, but they had a lot of money which was not invested in the right places. I am interested in the points raised about Northern Ireland and the United Kingdom and their investment in organ procurement. What do they actually do?
I address the next point to Dr. Colman O'Loughlin. I have sat in a room in which someone has asked my family the question to which he just referred. It is a very tough question. One's initial reaction is "No - not in a million years." When one gets a second opinion after a day or two, one lives in hope and considers that if there is anything that can be done for other people, it is the right thing to do. When we were asked the question, the issue was dealt with in the most compassionate way possible. As a member of a family which was involved in an organ donation decision 20 years ago, I believe that a little piece of our family member is still out there in some community or family where someone is living a full life. Someone used the phrase "a lifeline of hope". It is important that when people face that terrible time in their lives they have as much information as possible. It must be told to them with the greatest compassion and understanding that they are being asked to allow someone who has been in their life to pass on while someone else is given a new lease of life.
As much information as possible must be given compassionately to such families, and it must be explained to them that someone dear in their life could give someone else a new lease of life.
I found the briefing material interesting to read. At a meeting yesterday with the Minister for Children and Youth Affairs, Deputy Frances Fitzgerald, she informed us that we need €1.5 billion every month to keep the State afloat and pay people’s wages. It is a sad reflection on all of us that when we had plenty, more was not done in helping agencies such as this. Coming from a donor family, we certainly appreciated the way we were dealt with and it helped heal some of the sadness involved. It gave us a different appreciation of the dilemma of making life-changing decisions when it comes to organ donation.
I have been observing this debate for six years and have come to the conclusion it is a fundamental failure of the political process. No amount of money will make any difference to our organ donation system until we have the correct procedures and structures in place. I was in the Seanad when Senator Feargal Quinn introduced his presumed consent legislation, which was hotly debated. When one reads the headline, it might make sense. However, when one delves down into the matter, it is clear it does not work unless there are systems behind it and co-ordinators who would meet the families in question to ask them to consider donation. A process is needed, but we do not have one in place.
In the public consultation process on the matter in 2009, 23 out of 30 organisations involved stated that presumed consent is not the way to go. I believe we are now going to have another public consultation. There is nothing like having another report on what we already have been told. Having a report and pretending there is action does not deal with the problem.
In 2012, the EU directive on organ transplantation was implemented in Ireland. Many of the delegation were in Dublin Castle when we had what I can only describe as a box-ticking exercise. It involved officials from the HSE discussing a directive, a draft of which was not available to anybody in advance of the meeting, which meant we were all talking in generalities. After having made my contribution at this meeting, I found it amazing that the directive was not put before the Dáil, the Seanad or the health committee but was signed in on the last possible day, 28 August 2012, by the Minister. That was a failure of process. It was a significant opportunity missed.
Our first organ transplantation legislation in the State was itself a failure of process. Here we are now talking about presumed consent, which would not make a blind bit of difference if we brought the legislation in tomorrow morning because there would be nothing underneath it to support it. There would be no system to ensure people could talk to families about organ donation. We could have a required request system, which would be more effective. Again, however, unless one has the structures in place, it cannot work. It is a failure of our process that our first organ transplantation legislation in the State was introduced last year but no legislator had any input into it and the concerns of the delegation were not taken on board.
Is it correct that under a regime of presumed consent, the doctors involved would not necessarily go over the firmly expressed opinions of the relatives if they said they would not allow donation? People may think this is a recipe for contention between medical staff and families involved, when it is not.
Dr. Liam Plant:
Senator Crown asked about staffing levels. I can provide him with the exact staffing level for nephrologists, which will likely reflect on the other specialties in question. The mean number of consultant whole-time equivalents per million of the population in the United Kingdom is 7.4. In the Republic of Ireland, it is 4.6. There is also a regional disparity, with about 6.3 per million in the HSE Dublin north east region but 5 in the HSE south region, 3.8 in the HSE west region and 3.6 in the HSE Dublin mid-Leinster region. The second metric, which is similar, is the mean number of consultant whole-time equivalents available per 100 end-stage kidney disease patients. In the UK it is 1.1, while in the Republic of Ireland it is 0.6. Again, there is regional variation. These data are accessible on our website at hse.ie/nro.
I profoundly agree with Deputy Catherine Byrne on the fact that there is no pot of gold at the end of the rainbow. However, we have revenue locked within the programme for treatment of end-stage kidney disease. There is €100 million for costs attributable to dialysis. If a proportion of those patients received a transplant, that revenue would no longer be required. With respect to Senator Crown, I do not believe we will have a situation in which we will not dialyse people. I cannot envisage that happening. However, if we do not increase access to transplantation, the numbers on dialysis will continue to increase.
We have reduced costs dramatically in the past three years, but no matter how cheap one makes it, a patient has to have this treatment 156 times a year. Senator Crown used the word “malfunded”. The taxpayer, through the HSE, is funding end-stage kidney disease treatment. It is a question of which way we want to do this. Unusually for a health care issue, in this case the treatment that is the highest quality and has the best outcome is the cheapest.
Dr. Ruairí Dwyer:
We hear anecdotes about families requesting that an organ donation not be made. We see that as a major failure on our part and it is something we go to great lengths to avoid. If it is any comfort, it seems to happen rarely. There was a formal audit of potential donors in 2008 which found that less than 5% of families asked that organs not be donated. Part of our routine with all patients is to ensure the family has been offered the opportunity to allow for organ donation. We are well aware of the long-term benefits to the patient who receives the organ donation. The organ donor co-ordinators support the whole process. Our job in intensive care is primarily looking after the living. We also see organ donation as an integral part of our job, but with the EU directive there is an incredible amount of paperwork in place or coming down the line in this area. If this can be dealt with by the co-ordinator rather than being added to our workload, it will facilitate the process of organ donation considerably.
It is perhaps not the business of this committee but the issue of the single transplant centre has been raised by a number of members. I may have a different perspective compared to others. There are synergies in having a transplantation centre as part of a general hospital that would be lost in having a single transplant centre. At a time when we are trying to merge obstetric hospitals with general hospitals, there might be negative effects in terms of access to specialists in many areas. In the case of kidney transplantations in Beaumont Hospital, there is access to endocrinologists and a large general intensive care unit that would not be available in a single centre.
I will pass on some of the other questions which will be answered by my colleagues.
Dr. Colman O'Loughlin:
I would like to address the question raised by Deputy Billy Kelleher about whether it is the treating doctor who raises the issue of organ donation with the family. It is the treating intensivist who does it. By necessity and largely because the process begins when a patient is admitted to an intensive care unit with a brain injury which progresses to brain death, we recognise this process quickly and in all of our interactions with our very sick patients - the sickest patients are in intensive care units - we focus on the family dynamics because they are extraordinarily overwhelming and very difficult for us, as well as for the families involved. From the outset, we pay particular attention to developing a bond with the families. We must explain the concept of brain death. As many learned individuals still struggle with the concept, trying to explain it to a family coming in cold is difficult. Their relative is warm and has a pulse, the screen monitor looks normal and yet he or she is dead. One then throws organ donation on top of this. We develop a bond and try to build trust, which is extraordinarily important and can make a significant difference. The corollary - lack of trust - can blow everything out of the water. We must, therefore, be very careful in that regard. It is necessary that the person involved with the patient is present when one brings up the issue of organ donation.
Should we have support? Yes, we should, but we do not have it. We have an organ procurement office in Beaumont Hospital run by a fantastic group of people who are also transplant co-ordinators. Having a procurement person who is also a transplant co-ordinator and on both sides of the fence would be horrendous in any other civilised country. That cannot continue and must stop. We must have a dedicated organ procurement office staffed separately from transplant co-ordinators. They are different jobs and should be staffed differently. Should they be in a position to come to the hospital when we have a potential organ donor? Yes, they should. I did most of my speciality training in Melbourne where there was a fantastic organisation called Life Gift Victoria which was run by the government rather than medics. It had people on call to arrive at a hospital within whatever timeframe was possible when they heard about a potential organ donor. They were present when one approached the families and would have received specialist training. I have received as much training as I can have in this area. I have 30 other patients in my intensive care unit at the same time, but these are the people who are dedicated to this cause and have fantastic skills. Therefore, we should have them.
To respond to some of Deputy Catherine Byrne's comments, this is a very difficult time. We are very encouraged when a family comes forward to us with its support for the organ donation process. We must bear in mind, however, that it is within the right of the family not to go down that route. We must be very careful not to guide it one way or another. We can bring up the issue. That is the best we can do with trust. I am very glad the Deputy had a positive experience with the medical specialists with whom she dealt. We focus on that relationship with the family, which is incredibly important. I do not have strong feelings on this issue because the family has the ultimate say as to whether to opt in or out. As Professor Hickey said, we would never overrule its decision. Generating trust with the family and developing that bond is very important for us.
Any external influence such as the presumption of consent or the idea that altruism is being removed from the process is potentially dangerous. I do not have any figures for the committee, as the research is very weak. Mr. Joe Brolly, whom we all should congratulate for raising the topic, continually describes the euphoria he felt in gifting his kidney. That is important - he gifted it and felt euphoric. There is a small chance that the concept of the presumption of consent might take away slightly from this; therefore, it is very difficult to bring that argument into the process.
Dr. James O'Rourke:
I echo what Dr. Dwyer and Dr. O'Loughlin said. I am strongly committed to organ donation and believe families get much solace in the long term. Deputy Catherine Byrne described her experience. I had one experience a number of years ago of a small child who died and there was almost a case of medical misadventure. I remember sitting with the parents in the room and not bringing up the issue of organ donation. In retrospect, I would do so today. I would not miss that opportunity again. There are very few opportunities where the potential for organ donation is missed because the issue is not raised by me and my colleagues in the intensive care unit.
Going back to the resource implications, most organ donation result from the intensive care unit. There are patients who never reach the intensive care unit owing to resource restrictions who could become organ donors but are not given that opportunity owing to limitations in the number of intensive care beds. I do not have anything more to offer.
Professor Peter Conlon:
Deputy Catherine Byrne commented that there was no pot of gold to fund the health care system. As each kidney donor will save about €700,000, one could consider a kidney donor to be a pot of gold. When one multiplies this figure, the economics of transplantation are enormous. I said up to €300 million could be saved over ten years by treating kidney failure predominantly by way of transplantation rather than by dialysis.
Senator Colm Burke spoke about whether we could cope with the level of transplantation. As we said, we cannot. We have 100 pairs of donors and recipients waiting to donate a kidney to each other. Therefore, it will take us three years to do it. With this in mind, we have put together a business plan to very rapidly try to expand capacity.
Professor Peter Conlon:
Many of the elements of the plan are in place to be rolled out in the next six or 12 months to build an immediate short-term transplant unit at Beaumont Hospital, to commit to a larger unit in two or three years and appoint 30 staff. We have approval to appoint 30 staff. The consultant appointments committee is delaying the process. We have worked hard in recent years, but it will require the implementation of this plan and reaching the next second and third stages to have any hope of coping with the numbers of patients mentioned.
Dr. David Hickey:
I again thank the committee for giving us this opportunity. Everything has been more or less covered. All of the questions have been adequately covered.
I was very interested to hear about Deputy Catherine Byrne's personal experience. I think she would agree that if she had not been offered the opportunity, it would have been a source of sadness for her family. It is a service to the donating community.
The single unit will be located on a university hospital campus such as the one in Oslo in order that we would have our great anaesthetic colleagues beside us all the way. In respect of cost, it is a question of what is the priority. There is a hospital just down the road from here called the Mater hospital, with a plaque on it dated 1846, when construction of the hospital began. That was in the middle of the Famine and there was a set of priorities. It is still a leading hospital.
Professor Conlon has said it is cost-effective to do it, but how a society looks after this group of people who suffer a slow death over a period of years makes a statement about it. Money should be made available for this centre. It should be an attractive career for people who will want to spend their lives in it. The way to do this is to have a single centre that will be state-of-the-art and in which where there will be no triplication of services and in which all units will be brought together to develop a centre that will be worthy of this country and the community we serve.
To reply to Senator John Crown's question, we are being distracted from looking after people by meetings with ambivalent paraprofessionals in the hospital setting. This centre needs to be governed, managed and funded by an organisation such as the national organ donor and transplantation office and answerable to this committee, the Government and, ultimately, the people. The patient has been pushed down the priority list in health care. It is all about budgets, targets and business speak. We need to get back to doing what we would want to be done to us if we were sick.
Dr. Liam Plant:
Given the expertise on offer at this meeting, we have focused on kidney transplants, in particular. However, it is important to acknowledge that dialysis can be provided for those who cannot have a kidney transplant, whereas our fellow citizens who have cystic fibrosis or are dealing with heart or liver failure are in more difficult circumstances. The absence of a transplant does not mean they will cost the State X euro in replacement therapy; it means a loss to their families or communities. We have not focused on this issue sufficiently. We should not forget the people in question. The Republic of Ireland has the highest frequency of cystic fibrosis in the world. This is another group of people who present a particular charge to the success of this project.
In the context of all-island and east-west co-operation, there are bilateral agreements between hospitals and consultants may have personal relationships with their counterparts in Britain and Northern Ireland, but surely when we develop a national transplant centre, we should pool resources on an all-island basis. I acknowledge that the Mater hospital was built during the Famine of the 1840s and that we should have a statement of intent, but the greater good can suffer, even in the context of the national children's hospital. I am not denying all of the good that has been done, but we should consider the bigger picture.
I concur with Deputy Billy Kelleher. On my question about the current complement of those practising, Professor Hickey has indicated that it is in the order of 20 whole-time equivalents. What is the current complement across the board of kidney and all other relevant specialties and what figure does he believe it should be?
On the concpet of presumed consent, all of the views expressed indicate an acceptance that the next of kin or family should retain the right to give final approval. I presume the delegates would agree, but it is not something that we should be afraid to address. Donor card holders are making a very clear statement, but is it also the case that next of kin and family have the right to intervene and say "No"? An issue arises both in terms of the current situation and what might apply in terms of presumed consent, but it is very strong in the case of donor card holders. It is a matter that should be addressed because if it was my wish as a donor card holder, I would be strongly of the view that my family has no right to object.
Dr. David Hickey:
As far as I am aware, the concept of presumed consent is not practised anywhere in Europe. It is in the books, but it never happens that a family is sidestepped in this situation. If one person in the family is uncomfortable, the story is over because we do not want to cause more trouble and strife. The donor card is a useful vehicle for those who are looking after someone who has just died to bring up the topic. If the family is not interested in engaging, that is the end of it. While one could argue legally in favour of going down that road, people who have struggled to save somebody for three or four days understand the situation very well. The donor card is useful and the concept of presumed consent may offer a similar vehicle in making organ donation the norm rather than the exception. In a not insignificant number of intensive care unit cases, the topic is raised by the family. That is great for everyone who is looking after the patient because it is not necessary to initiate the request.
In terms of numbers, we have four full-time equivalents. All of our transplant surgeons also perform significant urology procedures. Some perform more significant procedures than others, but they have a second job, which is often very busy. These four full-time equivalents are involved in transplants and organ procurements, as well as looking after the national children's transplant unit, which used to be in Beaumont hospital but has been moved to Temple Street Hospital. Two of us are double jobbing in that regard. As Dr. Plant noted, we have half of the necessary numbers when compared with the United Kingdom and these are not blue ribbon numbers. We are way behind what we need. If a transplant surgeon is confined to working 48 hours per week and he or she happens to be on duty over a weekend in which a couple of donors become available, that is the week gone. Twenty might be an exaggeration, but it would not be a great exaggeration.
Dr. Liam Plant:
Deputy Billy Kelleher's question resonates with my own experience of moving from Scotland to Ireland. I asked my colleagues why we were not participating with others in other parts of these islands. If one is operating in a wider geographic catchment, typically there is movement of donor organs within an area. This means the time between organ removal and placement becomes extended in what is called a longer cold aschemia time. The cold aschemia time in the Republic of Ireland is considerably shorter than it is in the United Kingdom. There is an inexorable logic, whereby four or five areas joined together, with a common rule of sharing, will produce an imbalance of trade after a period of time because smaller areas will disproportionately provide more organs for larger areas. The other issue is the nature of the background donor population. Our ethnic background and age structure are different from those in the United Kingdom. Kidney donors on this island tend to be younger, the cold aschemia time tends to be shorter and such an imbalance of trade is relatively minor. When I first returned here, I was strongly of the view that we should share, but my experience and observations over time have led me to believe we are just about big enough.
Dr. David Hickey:
It is an important question. We had a sharing arrangement with the United Kingdom between 1989 and 2001. Everything Dr. Plant described came to fruition. There was a negative balance of trade every year and, because of transportation, even for the best matched imported kidneys, we had no knowledge about who had removed them, how they had been managed in ICU or the quality of the ICU concerned.
We had no control over that. The best-matched imported kidneys did worse than the worst-matched local kidneys and we pulled out of that arrangement. Generally speaking, again, with 60 millionin the UK, the smaller centres do not get the rewards. They become demoralised, their efforts deteriorate and organ procurement declines as a result. That has been the situation in the US where big centres have cannibalised small centres, and everybody is a loser when that happens. We must maintain our own integrity here. There are situations where a bigger pool like the UK is important, such as the paired organ exchange which Professor Conlon is running. We are involved with the North for pancreas transplantation. There are 27 co-ordinators there. Maybe they could spare some for us. Involvement with the North may be a possibility. Professor Conlon would know better than I do. I do not know. In terms of the deceased donation rates here, we should look after our own people first and export what we cannot use.
Mr. J. P. McDowell:
Deputy Ó Caoláin sought clarity on whether someone who has a signed organ donation card still requires the consent of the family after his or her death. The law, as introduced by the BSI last year, provides that the family's consent is legally required. So even when one has a kidney donor card that suggests that one is happy for one's kidneys to be used in the event of one's death, the law states that the consent of the family is required.
Dr. Colman O'Loughlin:
It is comforting to us, as the intensivists who interact with the families, that there is legal protection. It would never be the case that we would do it anyway. The donor card has always been a guide, an important guide. Most families would be aware that the person carried an organ donor card, and by and large they would be supportive if they were aware. There are occasions when the patient has had a donor card and the family has not agreed and we go with the family on every single occasion. It has never happened in Europe but there was a case in Singapore where there was a physical fight in the intensive care unit on this issue and I do not want to get into that in any shape or form in my practice, but it can happen.
Dr. Ruairi Dwyer:
I return to Deputy Ó Caoláin's earlier question on whether there is a risk of decreased donations with presumed consent, and there is. That is why many of my colleagues are concerned about this. Brazil introduced presumed consent some 15 years ago and it was followed by a decrease in donations, so they reversed it. The experience in Europe has been different. Where European countries have introduced presumed consent, associated with a strong campaign to gain social support for this, there seems to have been an associated increase in donations. There is data from two centres in Belgium where one centre adopted presumed consent and the other did not. There was a major difference in organ donation rates over the following couple of years in the presumed consent centre.
Prof Peter Conlon:
To address the question of sharing organs among larger areas, many factors go into making up how well kidneys do five and ten years out. The results in Ireland are better than in the UK and much better than in the US. So smaller, in terms of not sharing kidneys over long distances, is often better than sending kidneys that are 24 hours on ice and have travelled half way up and down the country.
We will resume the second part of the meeting. I remind members, witnesses and guests in the Public Gallery to turn off their mobile phones for the duration of the meeting. This is the third and final hearing on organ donations in Ireland. We will examine the policy perspective with officials from the Department of Health, the HSE and the Irish Medicines Board, IMB. I welcome Ms Mary Jackson, Professor Jim Egan, Dr. Siobhán O'Sullivan and Dr. Patrick Costello.
Before I commence I remind witnesses about the rules on privilege. Witnesses are protected by absolute privilege in respect of their evidence to the committee. However, if a witness is directed by the committee to cease giving evidence in regard to a particular matter and continues to do so, the witness is entitled thereafter only to a qualified privilege in respect of his evidence. Witnesses are directed that only evidence connected with the subject matter of these proceedings is to be given and are asked to respect the parliamentary practice that, where possible, they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable. Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the House or an official either by name or in such a way as to make him or her identifiable.
I offer apologies on behalf of Deputies Kelleher, O'Caoláin and Mitchell O'Connor and Senator Colm Burke who have to attend other meetings. Sometimes on the graveyard shift in committees, members have other commitments they cannot get out of. Nevertheless, I thank the officials for attending. This is an important issue and I call on Ms Mary Jackson to make the opening remarks.
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.
Dr. Siobhán O'Sullivan:
I thank the committee for the opportunity to address some of the ethical questions arising in the context of consent for organ donation and, more specifically, the pertinent ethical issues to be considered when introducing a presumed or opt-out consent model. As chief bioethics officer in the Department of Health, my role is to support the Department in achieving its mandate and strategic objectives through the provision of bioethical analysis and advice.
The success of any organ procurement system is contingent upon its capacity to fulfil three interconnected objectives: good outcomes in terms of quantity and quality of organs; the maintenance of public trust in the transplantation system; and respect for ethical principles. As the need for organs increases worldwide as well as here in Ireland, transplantation systems have explored a number of innovative strategies to increase donation rates, many of which have proved ethically challenging. Strategies include expanding the criteria for declaring death, living donation, donation after circulatory death, anonymous donation, directed donation, opt-out policies and even the introduction of economic incentives for donors. These strategies are not necessarily unacceptable, but they are morally debatable. While the ultimate goal is to save lives and improve the quality of life for transplant recipients, this goal needs to be achieved through means that do not violate socially accepted ethical norms.
Gift giving or voluntary donation to benefit another person as an expression of altruism and social solidarity has been the ethical cornerstone of organ procurement and transplantation in this country. Traditionally, the practice has been institutionalised as an opt-in system, which depends on having the express or explicit consent of the person or obtaining the consent of the person’s family after death. The presumed consent model has been adopted by a number of countries in Europe and globally in an effort to boost donor numbers. Ethicists have pointed out that the term "presumed consent" is something of a misnomer, as consent is an active rather than a passive process, and thus we prefer the term "opt-out", which we believe is a more appropriate use of terminology to describe the model.
The principal ethical objection to the opt-out model is the loss of autonomy and the right to self-determination of potential donors. Opponents also argue that the fact that someone did not register an objection to donation does not necessarily mean that he or she agreed to be a donor. It may simply mean that he or she had not read the necessary materials, did not know the relevant facts, or was otherwise unable to participate in the debate over organ donation. This could lead to the removal of organs from those who did not wish to donate - so-called false positives, if one likes. Commentators have argued that this situation is morally unacceptable because it violates the principle of respect for autonomy that underlies our concept of informed consent. Fears have also been expressed that an opt-out system could undermine solidarity and altruism as important motives for organ donation. It has been argued that the State, acting through health professionals and the transplantation system, would be intervening to take organs rather than facilitating their donation. There is at least a risk that some degree of trust in the system could be lost, potentially decreasing the availability of organs for transplant.
Proponents of the opt-out model counter that if a change of policy from opt-in to opt-out were to be broadcast widely, there would be no diminution of the exercise of self-determination and therefore personal autonomy would not be affected. Furthermore, it has been argued that an opt-out system enhances autonomy, as public surveys have shown a high willingness on the part of the public to donate their organs; thus, by failing to remove people’s organs, one is acting contrary to their wishes, even if they may be unexpressed wishes.
Supporters of an opt-out model also employ what we in ethics would call a utilitarian argument. This basically means that one provides the greatest good for the greatest number of people by harming no one and benefiting many. This particular thesis hinges on the fact that the dead or least their surviving interest cannot be harmed and that any curtailment of individual freedom is legitimate in the interest of the common good - that is, the survival of other citizens.
Another argument proffered in support of a policy change to an opt-out system is that it would facilitate a change in attitude - members heard that earlier this morning - so that donation would be increasingly seen as natural or normal, hence increasing the likelihood that families would conclude that donation was in line with their deceased relative's wishes.
I respectfully suggest that there are a number of ethically relevant considerations in introducing an opt-out system in Ireland. I am sure some of these will be considered as part of the pubic consultation process. In advance of any change in the system, the population should be informed of and receive relevant information on changes to the current arrangements concerning organ removal. This is to allow them to exercise their right to self-determination and opt out of the system if they so wish. There should be a simple and convenient procedure for anyone to opt out and it should be possible for individuals to revise their wishes at any time. We are all aware that our values can change over a lifetime depending on our personal experiences, and therefore that kind of facility is essential. It must be ensured that poor language or reading skills, a low level of educational attainment or poor socioeconomic or health status do not result in anyone’s understanding being limited to such an extent that his or her silence could be construed as consent to organ donation. The issue of how we might deal with vulnerable groups requires special attention.
Under a presumed-consent system, hospitals would need to have reliable and continuous access to the latest recorded wishes of potential organ donors. It would require a definition of who is responsible for the documentation, who is allowed to enter records, who has access to the information recorded and when. Some countries - for example, Sweden - do not allow access to the register until brain death has been diagnosed. This is to ensure the population does not get the idea that the system is effectively keeping an eye out for potential donors. Other countries actually allow checking of the register before the second set of brain-death testing takes place. These are all important things to take into consideration. We need to have regard to who would have access to the information and how that information is managed. There are also the more mundane, but nevertheless important, issues of data protection and data security that need to be taken into account. We would need to ensure that records are valid and correctly assigned, because it is important to be able to correctly identify the individual and his or her wishes.
Not least, the State has a responsibility to prevent the social stigmatisation of individuals who might opt out for their own reasons and who may not wish to be part of the process and thus may be regarded by the rest of society as lacking in solidarity. We must do some work in this regard. It is important to emphasise that deceased donation is a complex area, affected not only by law, administration and infrastructure but also by ideology and values. That is why I am especially grateful to have had this opportunity to address the committee on issues which are slightly off-kilter but centrally important.
Professor Jim Egan:
I thank the committee for the opportunity to speak today on this important topic for many families in the country. I was appointed as the HSE's director of the national organ donation and transplantation office via the Royal College of Surgeons and Royal College of Physicians in April 2011. I am a fellow of the joint faculty of intensive care medicine. I am the Irish representative on the Council of Europe committee on organ transplantation. I am a former chairman of the European Respiratory Society transplantation group, and am the co-chair of the International Society of Heart and Lung Transplantation committee for the management of chronic rejection.
I am privileged to be involved in the care of patients and families who are awaiting organ transplantation. I have had the benefit and fortune to work with wonderful surgeons such as David Hickey, Oscar Traynor at St. Vincent's University Hospital and Jim McCarthy at the Mater hospital. These are highly skilled individuals who execute this form of treatment. I am continually humbled by the generosity of Irish society and the Irish families who donate in the most difficult of circumstances - truly Olympian events which affect other people's lives - and save lives on a regular basis.
The three distinct transplant programmes in this country are unique in that, although located in university teaching hospitals in Dublin, they must provide a service for the entire nation while competing for resources with other regional and acute local services in those hospitals. At present, 685 patients and their families are awaiting transplantation in Ireland. Organ donation in Ireland is based on an opt-in system, and thankfully it is rare for somebody to die in circumstances which allow organ donation. Of 3,000 deaths in intensive care units per annum, approximately 80 to 100 cases are patients in these circumstances. In 2010 only 58 donations were made. The procurement and co-ordination of organ donation is provided by the renal transplant service because of the absence of standard formal structures. This gap has been filled very successfully in a voluntary capacity based on historical needs over many years.
Internationally, many stakeholders emphasise the benefits of organ transplantation. The European Commission Action Plan on Organ Donation and Transplantation (2009-2015) emphasizes the substantial health care benefits of organ transplantation and states that all European states need to identify potential organ donors and support their conversion to actual organ donors. The goal of soft opt-out is to allow organ donation to be the society norm. It does not devalue organ donation as an extraordinary gift from one family to another. However, soft opt-out legislation alone does not enhance organ donation. It is part of a package that includes donation infrastructure. Donation infrastructure protects the interests of families and donors, ensuring a compassionate and professional approach at the time of donation.
Earlier, we heard subjective views on specific data, but there is specific data which supports presumed consent. A review of presumed consent published in BMJ, formerly known as the British Medical Journal, indicates that it is associated with a 25% increase in organ donation rates, or an additional two to six donors per million of population. This is further emphasised in the UK health technology assessment report mentioned by Dr. Plant earlier today. European league tables of organ donation rates are consistently dominated by those countries which have presumed consent in partnership with formal organ donation infrastructures, including Spain, Portugal and Croatia. Generally speaking, we quote the Spanish model as the international standard for organ donation and transplantation, but Norway is also an excellent role model.
To comply with society's expectations and national and international needs, three structures must be deployed in the Irish health service, and we are actively working on these. Intensive care key donation personnel would be assigned throughout the health service in line with international practice and the European Commission action plan. These medical and nursing personnel will underpin the organ donation process by protecting the interests and welfare of those families who choose to donate organs in the most difficult of circumstances. The second element of infrastructure development is the national organ procurement office, which would be developed to be independent of recipient co-ordination to comply with the standards required by the EU tissue directive and the EU organ directive. It would also be in keeping with the 2011 HSE-commissioned independent international review of transplant services we completed and the recommendations of the Irish Medicines Board, which regulates this area. The third element is the recently established HSE national organ donation and transplantation office, which would be positioned to establish a financial and governance framework to protect the interests of donors and recipients in the current challenging fiscal environment.
Deploying these three structures would will bring Ireland in line with international practice norms, mitigate the risks of a fall in organ donation rates in a changing society - a very significant risk based on the experience in 2010 - potentially remove up to 530 patients from dialysis over the next ten years, and save up to 750 additional lives of patients with advanced liver, lung and heart disease over the next ten years. These structures would also provide a platform for co-operation with services in Northern Ireland. In a very measured fashion, deploying these structures would save up to €60 million over the next ten years.
It is our goal to have one of the very best organ donation and transplantation systems in Europe and we are deeply committed to this. I thank committee members for their attention and I am happy to take any questions in due course.
Dr. Patrick Costello:
I am the blood, tissue and organ manager at the Irish Medicines Board, which is one of two competent authorities appointed for implementation of the 2010 directive which sets the standard for the quality and safety of human organs intended for transplantation. This was transposed through SI 325/2012. The other competent authority is the HSE, which established the national organ donation and transplantation office as its representative and as a competent authority for implementing the legislation.
The legislation is relatively limited and divides the two organisations' roles. The Irish Medicines Board, IMB, is responsible for the inspection and authorisation of procurement organisations and transplantation centres. It is also responsible for reviewing adverse events or reactions that are attributable to the quality and safety of a transplanted organ. The HSE has a wider role in implementing the legislation. It must develop the framework for the quality and safety of organs. This includes issuing guidance to health care establishments and professionals on best practice in transplantation. It has a role in the establishment of a donor and recipient registry and in the control of organ exchanges between Ireland and other member states. It also plays a critical role in respect of reviewing and learning from adverse events and reactions.
The IMB has been appointed to its role because we have a history of regulating health care facilities, in that we were responsible for implementing the blood and tissue legislation. There is an overlap between tissues and organs. In theory, multi-organ donors could become multi-tissue donors as well. Two of our organ centres are also tissue establishments. We are committed to working with the HSE, the Department of Health and our clinical colleagues, from whom the committee has heard, in the implementation of this legislation.
I apologise for Deputy Ó Caoláin's absence. He must shortly leave for a meeting of the joint executive of the North-South Interparliamentary Association in Stormont. He wishes that he could have been present.
I thank our guests for their presentations. We also received presentations last week. Our guests are more than welcome, as this is an important issue. We support an opt out. It is important that donor card holders discuss their intentions with family members so that there is a lesser onus on those members to make a decision. Resources need to be invested in organ donation awareness campaigns, as we must promote donor awareness and encourage people to donate. We should roll out campaigns in schools. The younger that people become interested, the more it becomes a part of normal life.
Organ donation is one issue, but capacity, resources and infrastructure comprise another. A major investment is required to move us into line with best international practice. When reading the statements, I was struck by the fact that Ireland did not have a specific transplant centre or enough transplant surgeons. This important area is being run out of an office by five co-ordinators in Beaumont Hospital in Dublin who have other duties.
The Deputy First Minister, Mr. Martin McGuinness, MLA, recently indicated that he would introduce legislation through the Northern Ireland Executive to provide for presumed consent.
I thank the delegates. With any medical matter, public trust is a priority. Our first action when we go to hospital for any procedure, large or small, is to sign a consent form. We trust that the medical professionals caring for us will make the right decisions. I was struck by the query about what happens to homeless people and who acts as their voice. Will the delegates elaborate more broadly? We should not remove people's ability to make decisions on what happens to their bodies after they have been incapacitated. Their families should have a role in providing consent when the time comes for their relatives to pass.
All of the presentations at our recent meetings have been interesting. Some of the delegates may have been sitting in the Gallery when I referred to my personal experience of a family member who was an organ donor. It gives the gift of life to others. If those of us who must make this difficult decision keep in mind the fact that someone else is living because our loved ones have passed on, it gives some comfort. The person we lost is forever young in our minds, having only passed away at 20 years of age.
I thank the Chairman. I welcome and am delighted to see the team in attendance. When I introduced my Bill in 2009, few voices questioned the safety of or belief in presumed consent. There were many additions to the effect that, as Professor Egan explained well, presumed consent would only work if the infrastructure was in place. We also took on board a great deal of information about Spain.
We have heard little opposition to presumed consent, although there has been a question regarding finance. Savings of €60 million over a ten-year period were mentioned. Perhaps someone might touch on this matter. Such savings would address people's doubts in this regard.
I am frustrated by the length of time needed to get anything done in either House. We adjourned our debate and the then Minister for Health and Children, Ms Mary Harney, stated that she wished to take public opinion, but nothing has happened since. There are few voices against presumed consent, but such a system must be tied in with other factors. The only voice that was loudly not in favour of presumed consent was the Irish Kidney Association. What are its concerns?
Yes. I apologise for being unable to attend. I do not understand its concerns or why it does not approve of presumed consent. It seems that everyone else is in favour. I urge that we reintroduce my legislation or a Government Bill. With the committee, I visited the Minister for Health, Deputy Reilly, from whom there was no strong opposition. He seemed to be in favour of presumed consent as well, assuming precautions were taken. We can push on that open door. I hope that we do.
Ms Mary Jackson:
I take Deputy Byrne's point. The thrust in legislating for the opt-out or soft opt-out system is not meant to undermine trust or change our wonderful system, given the doctors' descriptions of what happens. Patients and their families must be put at the centre of everything. We want to consult on how best to implement a soft opt-out system so that we can get it right and take everyone's concerns into consideration.
Members of the Irish Kidney Association are present in the Gallery. I took Mr. Murphy's main point to be that we should not concentrate on the cold words of legislation alone, but on the practical elements, for example, proper infrastructure and people who can do the job of getting consent and maximising organ donation well.
Given the cost of implementation, Ireland faces a particular problem in setting up a register of donors, be it a register of opt-ins or opt-outs. Experience in the UK shows a low number of registrations, approximately 28%. Nor do we have a unique health identifier, which is another problem for legislation. If there are five Mary Jacksons living in my locality, how do I know who is who on the register? The practical, logistical and cost implications cannot be overlooked when putting a system in place.
Professor Jim Egan:
On the point raised by Deputy Catherine Byrne, unequivocally it will never happen that organs will be harvested without permission. The key terminology is "soft". This is a soft opt-out proposal which means the wishes of the family will remain to the front and at the centre of the whole process.
On Senator Feargal Quinn's comments, it is accepted internationally that there are substantial financial benefits to be accrued from transplantation. We have seen business cases proposed in the United Kingdom which underpin its substantial investment of almost £60 million in organ donation and transplantation. The United Kingdom sees this as a cost effective and cost neutral process. This is about preventing people from spending time on dialysis and saving money through the use of appropriate measures.
On Deputy Sandra McLellan's point on Northern Ireland, given that the population of the Republic of Ireland is 4.5 million and that the population of Northern Ireland is 1.8 million, it is eminently sensible that there be synergy from the point of view of the cost effectiveness of our working with our colleagues in Northern Ireland. We need to be on a sensible platform in that regard. As we have heard, they are way ahead from an infrastructural perspective. We need to get to a comparable position. We could then seek to work closely with them.
Dr. Siobhán O'Sullivan:
Deputy Catherine Byrne raised the issue of vulnerable categories. I, too, have concerns about what is proposed in the case of homeless persons and incapacitated adults. For example, some countries operating opt-out systems allow for children, whereas here parents act as advocates for children. We need to look carefully at this issue. The difficulty is that while in a soft opt-out, there may be a family that can act as an advocate for the deceased, there will always be marginalised groups in society which will not have that support. This needs to be recognised. There is a need for the inclusion of safeguards in relation to advocates acting on behalf of such persons. It is an issue that requires serious consideration and I thank the Deputy for rasing it.
On the question of autonomy, it has often be said the soft opt-out system allows greater autonomy because the person's wish - once a person has not objected, it is taken that he or she is happy to be a donor - cannot be overridden by the family and is, therefore, a much better system. However, any opt-out system operating in Europe involves the family. This is for practical reasons as much as anything else because one needs to ask the family practical questions about lifestyle and so on. Most countries operate soft opt-out systems, with Austria being the only country that operates a system in which the family is not involved. There are a huge number of variances in the systems operating across Europe in terms of family involvement. In Norway the family is very important and central to the process, with communication being the key. This is largely because Norway does not operate an opt-out register. As such, talking to the family is one of the only ways to establish whether the deceased person wanted to donate. In Belgium the family must be involved, but nobody is clear on what "involved" means. In other countries authorisation from the family is required. There are a large number of opt-out models which state how a family must be involved. This comes back to my final point, namely, that we must be aware of the ethical norms operating and values. In Ireland the family generally is involved. We need to be aware of how that is going to work and take this into account in our deliberations on how this might translate into legislation.
Ms Mary Jackson:
I would like to add one further point. I am not sure if it was said in the course of the discussion thus far, but an example of the commitment of the system to working to improve the position is the €3.5 million allocated to the living kidney donor programme in the HSE's service plan for 2013. At a time of very constrained resources, this is an important commitment. We know that transplantation is better for a patient and adds value to the system.
I thank the delegates for attending. This is the third of our series of meetings on the issue of organ donation. It is important that we continue to advocate and promulgate organ donation. The joint committee will meet in private session next week to consider how to progress and assist in the formulation of policy as outlined in the programme for Government. The briefings received today and in our previous two meetings will form a major part of our analysis, on which we will report back to the Department and the Minister.