General Scheme of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination, and Public Display) Bill 2018: Discussion

This morning we will have a pre-legislative scrutiny meeting on the General Scheme of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination, and Public Display) Bill 2018. We have witnesses from the Department of Health and representatives from the Irish Kidney Association, the Irish Donor Network and Organ Donation Transplant Ireland. On behalf of the committee I welcome to our first session Mr. Michael Conroy, principal officer, and Ms Helen O'Brien, assistant principal, from the Department of Health; Professor Jim Egan, director, and Ms Fiona Hammond, CEO, from Organ Donation Transplant Ireland; Mr. Mark Murphy, chief executive, and Mr. John Whelan, national secretary, from the Irish Kidney Association; and Mr. Philip Watt, chairperson, and Mr. Robert McCutcheon, Patient Group, from the Irish Donor Network.

I wish to draw the attention of those in attendance to the fact that by virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to this committee. However, if they are directed by the committee to cease giving evidence in relation to a particular matter and they continue to so do, they are entitled thereafter only to a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they 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 or her identifiable.

I also wish to advise witnesses that any opening statements they have made to the committee may be published on the committee's website after this meeting.

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.

I invite Mr. Conroy to make his opening statement.

Mr. Michael Conroy

I thank the Chairman and members of the committee for the opportunity to address them on this draft legislation. As the Chairman said, I am joined today by Helen O’Brien, assistant principal.

I hope to provide this hearing with the background to the Government decision to approve the General Scheme of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination, and Public Display) Bill, and to briefly outline the main provisions.

The general scheme of the human tissue Bill will create a modern legislative framework for consent for activities involving human organs and tissue. The introduction of legislation in this area is a priority for the Minister for Health and it will give effect to two commitments in the programme for Government: to prioritise the passage of the human tissue Bill; and to propose legislation for family consent and an opt-out register for organ donation.

The general scheme of the Bill proposes to regulate the removal, retention, storage, use and disposal of human tissue from deceased persons; provide general conditions for the removal, donation and use of organs and tissues from deceased and living persons for the purposes of transplantation; and provide for an opt-out system of consent for organ donation, and for an associated register.

The principles underlying the proposals are that consent would be the defining principle underpinning activities involving human organs and tissue; protection of the bodily integrity of the individual before and after death; respect for the autonomy of the individual and the rights of the bereaved; and, promotion of the public health benefits of organ donation and post-mortem examination.

The key recommendation of the report of Dr. Deirdre Madden on post-mortem practices and procedures was that no hospital post-mortem examination should be carried out, and no organ retained for any purpose whatsoever, without authorisation. The general scheme of the Bill will extend this principle to transplantation, anatomical examination, education and training and public display.

The development of this general scheme of the Bill has been a collaborative process. Two public consultations on the proposals were held, the latest in 2017. Stakeholders consulted through the drafting process included patient representative groups, the Medical Council, the Health Information and Quality Authority, the Health Products Regulatory Authority, the Office of the State Pathologist, the Coroners Society of Ireland, the Department of Justice and Equality and the Office of the Attorney General.

The proposed legislation is designed to be compatible with the Assisted Decision-Making (Capacity) Act and the coroners Acts. It will repeal the Anatomy Act of 1832.

The general scheme of the Bill comprises six parts. Part 1 deals with standard provisions such as interpretation. It includes provisions for the storage, handling, transportation, disposal and return of organs and tissue.

Part 2 outlines provisions in respect of transplantation. The general scheme of the Bill covers the transplant of both organs and tissues and outlines the requisite consent provisions in regard to deceased and living donors.

Transplantation is currently the only available treatment for end-stage heart, lung and liver failure. It is the most cost-effective treatment for end-stage kidney disease and it brings enormous clinical and social benefits to patients who would otherwise remain on dialysis. The success of transplantation, in terms of life years gained and improvements in quality of life for patients, as well as advances in treatment generally, has resulted in an increase in the number of patients for whom transplantation is considered to be a viable option. At the end of September this year, 577 people were on transplant waiting lists in Ireland, 499 of whom were on the kidney transplant list. Worldwide, the most significant problem affecting transplant programmes is the shortage of suitable organs to transplant.

The general scheme of the Bill proposes to introduce an opt-out system of organ donation. This approach has been widely adopted across Europe. Currently, the decision on organ donation in the case of a deceased person rests with that person’s next-of-kin, even in cases where the deceased person had an organ donor card or had indicated their wish to be an organ donor on their driving licence. Under the proposed opt-out system, consent will be deemed unless a person has, while alive, registered his or her wish not to become an organ donor after death. The intention is to make organ donation the norm in situations where donation is possible.

A soft opt-out system is proposed. Even though consent is deemed, the next-of-kin will, in practice, always be consulted prior to removing any organ. If the next-of-kin objects to the deemed consent, the donation will not proceed. Feedback from the public consultations, and from organisations involved, supports the continued role of the next-of-kin in the final decision on individual organ donations.

Under the proposed system, individuals who do not wish to donate can opt out. An organ donation opt-out register will be established and maintained by Organ Donation and Transplant Ireland, ODTI. If an individual has opted out through including his or her details on the register, they will not be considered for organ donation after their death and the views of the family will not be sought. The ODTI has commenced work on setting up the register. Appropriate safeguards will be included to ensure that the information is correct, that it represents the individual’s current views and that general data protection regulation, GDPR, requirements are met. Only the individual involved will be able to include him or herself on the register. Also, it will be possible for individuals to remove their name from the register at any time.

The proposed soft opt-out system recognises the practical need for family co-operation to obtain social and medical information about the donor. Safeguarding a future potential organ recipient involves the completion of a comprehensive donor lifestyle questionnaire which requires the co-operation of the next-of-kin.

The introduction of a soft opt-out system of organ donation is part of a range of initiatives being taken to increase the availability of organs for donation. They include the establishment of a national organ procurement service; the appointment of clinical leads for organ donation and organ donation nurse managers in each hospital group; the planned national organ retrieval service; and the retrieval of organs in more complex donor cases. The legislative proposals will be accompanied by a publicity campaign, the aim of which will be to boost organ donation, ensure people understand the opt-out system and encourage them to share their wishes for organ donation with their families.

The general scheme also provides for consent procedures and general conditions for the removal, donation and use of organs and tissue from living persons for transplantation and human application. The Bill includes a provision to prohibit the trafficking of organs and the removal and transplantation of organs outside an official transplant centre, thus facilitating Ireland’s ratification of the Council of Europe Convention against Trafficking in Human Organs.

Part 3 of the general scheme covers pathology practice or post mortems. This involves hospital post mortems or non-coroner post mortems only. The general scheme outlines the consent required for a hospital post mortem; who can undertake a post mortem; the purposes for which a post mortem may be undertaken; and provisions for the retention, storage, use, disposal and return of organs and tissue from deceased persons following a post mortem. The legislation will stipulate that individuals may not be paid for organs and tissue that have been removed as part of a post mortem and that such organs and tissue cannot be used for commercial purposes.

Part 4 covers anatomical examination. The Anatomy Act 1832 will be repealed and replaced with provisions appropriate to the current requirements of medical education. Provisions governing consent for anatomical examination, as well as the practice, licensing and governance of such examination, are included. The central pillar of these provisions is informed consent. An adult may, prior to his or her death, consent to the donation of his or her body or body parts for anatomical examination. Full and clear information should be provided outlining the nature of the anatomical examination activities, the length of time the donated body or body parts will be retained, arrangements for disposal and any other information deemed to be appropriate. The general scheme provides that anatomical examination, for the purposes of studying the structure of the human body, may only be practiced in a licensed institution, one of the five anatomy schools in Ireland. Anatomical examination, for the purposes of ongoing education and training in surgical and clinical procedures, may only be practised using a specimen loaned or transferred from a licensed institution. The import and export of specimens for anatomical examination is also covered.

Part 5 provides that a licence will be required for the public display of bodies after death and outlines the requirements to be fulfilled when applying for a licence. The provisions also outline the consent arrangements required and stipulate that only individuals who are authorised by the Medical Council may import or export specimens for public display. Offences and penalties are outlined in Part 6.

Work has commenced on the drafting of the Bill in collaboration with the Office of the Parliamentary Counsel. The Department hopes to be in a position to seek Government approval to publish the Bill by the end of quarter 1 of 2020 and that, subject to other legislative priorities, the Bill will progress through both Houses of the Oireachtas by the end of quarter 3 of 2020.

I thank the Chairman and the committee for undertaking this pre-legislative scrutiny of the general scheme. We look forward to receiving the committee’s report which will make a valuable contribution in the further development of the legislation.

Professor Jim Egan

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

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

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

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

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

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

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

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

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

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

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

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

I thank Professor Egan for his comprehensive opening statement. I now invite Mr. Philip Watt from Irish Donor Network to make his opening statement.

Mr. Philip Watt

I thank the chairperson and members of the joint committee for their invitation. We are delighted to be here to represent the Irish Donor Network, IDN, a network of seven patient groups which is in favour of the human tissue Bill. In particular, we support the soft opt-out organ donation system and the register. However, we are also calling for the necessary resources to fully implement the legislation.

I am accompanied by my colleague, Mr. Robert McCutcheon, who is the chairperson of the Irish Heart and Lung Transplant Association. He is also celebrating 12 years post a heart transplant and looking very well on it.

He is a great advert for transplantation.

Mr. Philip Watt

I would also like to acknowledge my colleagues in the Gallery, Ms Nicola Cassidy, Ms Nicola Hurley, Ms Ann Marie O'Dowd and Mr. Michael Geoghegan from the Irish Donor Network and various patient groups. We are dedicating our presentation to former Senator, Feargal Quinn, who sadly passed away earlier this year. He was a fantastic champion of organ donation and was very supportive of the soft opt-out system.

Organ donation is a precious gift that saves lives. In large part due to a shortage of organs, people continue to die in Ireland unnecessarily while on the waiting list for organs they desperately need in order to preserve and enhance their lives and health. One organ donor can potentially save seven lives. There are also benefits to their families, Irish society in general, the Irish health system and the wider economy in promoting transplantation. That is why IDN is committed to encouraging transplantation and to increase the numbers of donors and of lives saved. In this context, IDN warmly welcomes the introduction by the Minister for Health and the Irish Government of the human tissue Bill 2019, and in particular the provisions to provide for an opt-out system of consent for organ donation and for an associated register. We note that this change is also widely supported by most political parties in Ireland, the medical community and by the vast majority of relevant patient groups and the general public. We also note that it is an important part of the programme for Government.

However, we also wish to make clear in this submission that the ambition to make more organs available for transplant may be blunted or may not reach full potential if it is not accompanied by the necessary supporting resources and infrastructure. In particular, we need more organ retrieval surgeons and donor nurse specialists in our major intensive care units in our hospitals. We also need improved hospital infrastructure and staffing levels in the three transplant centres at the Mater, Beaumont and St. Vincents’ hospitals, including pre- and post-operative rooms and sufficient access to operating theatres.

We also need sufficient resources for a national public awareness programme and register, and some modest resources to help patient groups to support the public awareness campaign that will accompany the human tissue Bill.

The Irish Donor Network is made up of the following patient groups: the Alpha One Foundation; Chronic Obstructive Pulmonary Disease Support Ireland; Children’s Liver Disease Ireland; Disease Support Ireland; Cystic Fibrosis Ireland, which is my organisation; Cystinosis Ireland; the Irish Heart and Lung Transplant Association; and the Irish Lung Fibrosis Association, which is represented here today. Soft opt-out is also supported by the Irish Heart Foundation, the Irish Thoracic Society and the Irish Hospice Foundation and many other key stakeholders concerned with organ donation and transplantation in Ireland.

I will now turn to why the Irish Donor Network supports the human tissue Bill and soft opt-out. The IDN strongly supports the introduction of a soft opt-out system for organ donation, which basically means an opt-out system with inherent safeguards. The IDN has been campaigning for such a system for many years. Under the proposed new system, the donor’s next of kin would still be consulted, but deceased donors’ consent would be presumed unless there is evidence that they did not wish to donate. An alternative approach is the hard opt-out system, which has been tried in other countries including Austria, where next of kin are not consulted. This system has been shown not to work. It was tried in Austria and it failed, so we certainly would not suggest that system be brought into Ireland.

While it is always challenging to make direct comparisons with other countries, the decision to bring a soft opt-out system into Ireland follows the success of soft opt-out in many other EU countries, including in Austria, Spain and Belgium. There has also been a strong momentum growing in the UK to introduce soft opt-out in recent years. In England, the Organ Donation (Deemed Consent) Act has passed through the UK Parliament, with implementation due to start in April 2020. This will replace the present on line opt-in and opt-out system that has failed to deliver and which should not be considered for Ireland. Under the existing system in the UK, only 38% of the UK population has registered their wish to opt in on the existing online organ donor register, which is why most UK health bodies concerned with transplant are now seeking to replace this system with the approach that we are advocating for Ireland. The IDN does not want to import an opt-in and opt-out system into Ireland, because this system has clearly demonstrated failure in England.

Donor cards, apps, and codes on drivers' licences are worthy additions to a programme, and we pay tribute to the work of the Irish Kidney Association in developing these excellent public awareness initiatives. We believe there is no reason these initiatives would not continue into the future. They are not, however, a substitute for a comprehensive organ donor consent legislative process and a system based on evidence.

In Scotland, a new Bill was enacted in July 2019. In Wales, such a system has now been in place since 2015. Of 160 organ transplants in 2017 in Wales, 39 were organs transplanted using its deemed consent system. Only 6% of people opted out of the system in Wales. Authoritative research published by the British Medical Journal concluded that the change in Wales had a positive impact on donation but stressed the importance of resourcing transplant and donation infrastructure.

The groups involved in the IDN have been involved in supporting organ donation for many years. The IDN believes that, as part of a broader strategy, including improvements in organ donation and transplantation infrastructure with resourcing and organisation, a shift to an opt-out system will have a positive impact on donation rates. Independent research carried out by the University of York, which I will go into in detail, showed four major methodologically sound studies comparing donation rates in countries with and without soft opt-out and found that the practice of soft opt-out has been proven to increase organ donation in three of the four studies.

Research undertaken in Ireland shows that 80% or more support organ donation but only about a third of us tend to carry a donor card. The IDN supports the principle behind an opt-out system, that if people do not object to their organs being used after death they should be used to save lives. Under an opt-out system, individuals have the same choice as in an opt-in system - to donate or not to donate - so individual autonomy and choice are protected and respected under this proposed new system. The proposed new system is simply a change in the way people’s views are expressed. All organ donation is a gift and should be recognised as such in the future, irrespective of the model of consent in place. Families are often comforted by knowing something good has come from their loss. The expectation of IDN is that, under a soft opt-out system, organ donation would become the default position which, over time, would change expectations in society and so become the societal norm. Thus, there would be a shift where donation is a natural and expected thing to do.

We would also point to other aspects of the legislation that are important, such as the introduction of a living kidney sharing scheme. This has worked very well and is called altruistic donation. This allows a stranger and people who are not relatives to donate a kidney. This is working very well in Northern Ireland and 89 donors have provided such support in recent years. We also strongly support the public awareness programme and patient groups should be involved in this too.

People continue to die waiting for a transplant in Ireland. The submission from the seven patient groups of the IDN contends that the momentum in Ireland for change is growing, as it is with our nearest neighbours in the UK. As with all major changes, however, the introduction of soft opt-out needs to be accompanied by a persistent, continuing and adequately resourced public awareness programme, an online register and a significant additional investment in transplant infrastructure such as organ retrieval surgeons and other key specialised staff. We are delighted to continue to play a supporting role in this change. We hope that the living kidney sharing scheme would come in under the new legislation also.

IDN wishes to acknowledge the work of senior officials in the Oireachtas Joint Committee on Health, Organ Donation and Transplant Ireland and Professor Jim Egan, the HSE, and the Department of Health, led by Michael Conroy. We also thank the Minister, Deputy Simon Harris, the Minister of State, Deputy Finian McGrath, and all of the political parties here today. We urge that this legislation is enacted as soon as possible.

I thank Mr. Watt for his opening statement. I now invite Mr. Mark Murphy to make his opening statement on behalf of the Irish Kidney Association.

Mr. Mark Murphy

I thank the Chairman and members of the committee for giving the Irish Kidney Association, IKA, the opportunity to address it all and share our observations and suggested amendments to the Bill in question.

The IKA was formed 41 years ago to advocate for patients, and their families, affected by kidney failure. Our first mission was to introduce what was then the kidney donor card, raise public awareness about how kidney donation works and how it can be the gift of life. As transplantation progressed to include more organs the kidney donor card became the organ donor card more than 20 years ago.

The role of the organ donor card has always been to prompt the organ donation conversation within families as informed consent is key to the success of the process. Technology has allowed us to reach beyond the traditional card, as Mr .Watt mentioned, and we now also have a digital organ donor card app. The same principle applies in that the app is there to promote conversation and as a reminder of the decision made.

For more than a decade we advocated for the introduction of an organ donor register. This would offer a very clear call to action for the public and can be very easily established in such a way that facilitates the organ donation conversation.

With a register, Organ Donation and Transplant Ireland, ODTI, would have for the first time a central record of an individual's decision to be an organ donor. This would be consulted when a potential donor has been identified and knowing that a loved one had proactively recorded a wish to be an organ donor makes the family decision to consent a much easier proposition.

In putting an emphasis on soft opt-out with family consent, this Bill is misleading the public as it implies a change of practice, whereas the reality is that the practice stays the same. Currently, a potential organ donor is identified, the family is approached and consent for retrieval is either given or not. Under the proposals in this Bill, the public will have the opportunity to opt out of organ donation and if people do not opt out, they will be considered potential donors but the family will still be approached for final consent. Where is the difference?

We want people to say "Yes" to organ donation but just as important, we want their families to also say "Yes". How do we do this? We encourage conversation. The public will only look at the headlines of this Bill and see that if they do not opt out then they are considered potential donors, the call to action will be removed along with the prompt for family conversation. Do not just take my word for it as there are people a lot more learned than me who will say the introduction of a system of opt-out will not affect growth in deceased donors. A paper entitled Comparison of Organ Donation and Transplantation Rates Between Opt-out and Opt-in Systems, which was published this year states, "our data demonstrate no significant difference in deceased donation or solid organ transplantation activity between opt-out versus opt-in countries". This other barriers to organ donation must be addressed even in settings where consent for donation is presumed. The author concluded that greater emphasis on education and informing the general population about the benefits of transplantation is the preferred way to achieve an increase in organ donation. These findings have important implications for transplant clinicians and health policymakers like this committee when considering the merits of organ donation strategies.

Another paper entitled Opt-out Legislation, the Mysterious Viability of the False, was written by Dr. Rafael Matesanz and Dr. Beatriz Domínguez-Gil, the retired and current leader of the most successful organ donation organisation in the world, Organización Nacional de Trasplantes, ONT, in Spain. It states:

In summary, the evidence does not support that shifting towards presumed consent will solve organ shortage. But still today, this measure is seen as a magic solution that departs from conviction that low deceased donation rates result only from a negative public attitude and poor contribution from society. It results from ignoring that the key to success lies within the healthcare system. We should never blame the population. If people donate less, it must be something we have done wrong.

This is from the leaders of the donation organisation in the most successful country in the world in this practice.

Head 19 of the Bill focuses on an opt-out only register and is a major missed opportunity. Give the public an opportunity to opt in also. The register would go from being viewed negatively by wider society to being a useful call to action and decision aid for families when their consent is sought. The United Kingdom has had a register for 25 years and it also has detailed donor audit reports, which we do not, that show the evidence of the value of the register and the role of specialist nurses for organ donation. Again, we have very few of them. Only 30% of families consent when no specialist nurse is involved in the formal organ donation conversation with the family. That increases to 57.5% consent when the specialist nurse is involved but the potential donor has not signed the donor register. This increases again to 94% of families consenting to organ donation if a specialist nurse is involved and the potential organ donor has signed up to the register. It is hard to argue with such statistics, which is raw evidence for the committee.

With respect to developing a "Yes" or opt-in register we are actually already in a very strong position, with 957,000 people who have the new format driving licence or driving permit choosing to have the code 115 added to their licence to indicate their wish to be an organ donor. These data can easily be transferred to the Department of Health if the desire is there to make it happen. We have a number of edits for the committee to consider. My colleague, Mr. Whelan and I, worked on this for quite some time. We have plenty of supporting materials that we believe will help the committee make a truly informed decision on the future of organ donation in Ireland. I thank the committee for not presuming our consent to this Bill.

I thank Mr. Murphy for his opening statement.

I have an organ donor card that is probably a museum piece by now.

Mr. Mark Murphy

It is looking like it.

It is from 1989. I have not yet had to use it.

Mr. Mark Murphy

It is still as valid as it was then. Well done.

Did I meet the witness at the ploughing championships a number of years ago?

Mr. Mark Murphy

You probably did.

This is in my wallet. If I ended up dying tragically, would this be sufficient for my organs to be used?

Mr. Mark Murphy

It would be sufficient for your family to realise that you wished it to happen. The consent would not come from the Chairman but his family. They can see that you had a donor card and they would find it very difficult not to agree to your wish.

If this was not found in my wallet-----

Mr. Mark Murphy

It is a myth that the card is enough for consent. It was never a device to give consent but it is a reminder of one's wishes. We ask that the next of kin sign the card but the British version does not require this. Our card was developed seven years after the United Kingdom card and we sought that the next of kin would countersign. It is a reminder to the next of kin that he or she agreed to this. That was in 1989 in the case of the Chairman. The decision is still valid, as the Chairman still has the card.

In 1989 that might have been the only card in the Chairman's wallet but now there is pressure on cards to be included in a wallet. We have many cards, whether we like that or not. I suspect if the Chairman has the new format of driver licence, it has code 115 on it.

I do not think so.

Mr. Mark Murphy

You should check it. It probably does have the code if it is the new format.

Mr. Mark Murphy

By the time the ten-year period for fully rolling out the new format of licence is finished, there will be 1.4 million who have said "Yes" to having code 115 on the card. That is sufficient if a person does not have a donor card and it is a strong registry. It will be 38% of the adult population in three years. We have their decision to be an organ donor so it would be amazing to me if we do not want to use that resource.

I welcome the witnesses and thank them for coming in. We all know people who have benefitted from organ donation and I will take a moment now to remember donors and their families, who wished for the donation to go ahead. God rest those people who have passed away and well done to the families involved. Mr. McCutcheon is certainly an excellent advertisement and we should nearly put him on the television as a reminder of how a person's life can change.

Professor Jim Egan mentioned a proposed register.

Can I just get my head around it? If a person wants to opt out, he or she goes on this register. Otherwise, it is presumed the person wants to donate. I take it that is correct. With regard to the two UK registers, do many people not go on either register?

Professor Jim Egan

Mr. Murphy and I have debated this repeatedly over the years. The donor card, which has been championed laudably by the Irish Kidney Association for four decades, is a call to arms. It is a foil for discussion. The register is potentially a more formal structure but, at the end of the day, the register in many ways ends up speaking to the converted. With the infrastructure that the UK has put in, they at best get 40% of their population. We would anticipate 5% to 10% of folk are not into this. Then there is the population who will carry their donor card and will give. We estimate that at best that is 40% of the population. The remainder, 50%, are too busy and absolutely appropriately not thinking about organ donation. The core issue is to have the medical staff and nursing staff there to support the families in the decision, an education programme, a public awareness programme and infrastructure to support those families.

There is no magic bullet. It is about building a system like a jigsaw so that one has a comprehensive approach to organ donation. As Mr. Murphy said, the Spaniards have achieved this over three decades. We have made good progress since the European directive in 2012 but we are some way behind the sophistication of other jurisdictions. We need to build that.

I emphasis that there is no magic bullet. The legislation is not a magic bullet. I was at pains to emphasise, while we have no legislation, that probably the jewel in the crown is the infrastructure to support the families. We are in the business of saving lives and every effort is made to prevent somebody from dying. In tragic circumstances, we hope to have the infrastructure in modern medicine, as compared to when I started in the business. The intensive care units, the quality of care and the sophistication that goes on is breathtaking. We hope that in the general population, underpinned by the legislation, the mood music will be that people will consider donation after death because it saves lives.

I thank Professor Egan. Mr. Watt briefly touched on a public awareness programme. What plans are in place to educate and inform people?

Mr. Philip Watt

The experience in other countries shows, even though all the opinion polls show that the public and the key stakeholders are in favour of this change, that it is important that the change is explained to people through a public awareness programme and an education programme. That should be done jointly between ODTI and patient groups to ensure that the message gets across. Any kind of major change in policy has to be carefully explained and understood by the public. That is important.

That explains the joint effort.

Mr. Philip Watt


Is there ever a case where someone may wish to donate some organs and not others? Usually, if someone wants to donate, is he or she giving carte blanche?

Mr. Michael Conroy

One is able to specify.

Will that be the case in the proposed system?

Professor Jim Egan

We are absolutely respectful of the person's and the family's wishes. Indeed, if people elect not to donate, we are absolutely respectful of that.

Mr. Murphy wants to come in. Can I ask him as well? The soft opt-out seems to be a win-win situation. Can Mr. Murphy further explain his objections?

Mr. Mark Murphy

The public will read the headline but the consent system will be the same.

Is it that it comes down to the family?

Mr. Mark Murphy

There will be no change to the practice of asking the family for consent or authorisation. That will happen anyway. That happens and it will happen. The only difference is a "No" register. The intensivists are a little worried that they will have to arguably waste valuable time consulting that register because the Bill insists that they consult the register before they proceed to ask the family. They must check that the person is not on the register. The Intensive Care Society is quite annoyed that its members will asked to do this, which, if one looks at the statistics, will probably turn out to be valid in 2% of the cases.

If people had not discussed with their family their wish to donate, would the register make it easier for the families?

Mr. Mark Murphy

Only for 2%. If we had a register of all the people who said "Yes", it would make many more decisions easier because the vast majority will say "Yes" to organ donation and the family would be able to be shown the data that Johnny registered ten years ago that he wished to be an organ donor. One would be able to show the family. Rather than having the donor card in someone's pocket and leaving it to chance, it would be there on the register. The family, in the vast majority of cases will follow the decision, and studies from the UK prove that it is so in almost 99% of cases.

Regarding I stated earlier on the statistics, Professor Egan is correct. In the middle, I have the nurse specialists who are the ones we do not have. We need infrastructure to make this happen. That relates to the conversion rate. Being on the register and the nurse being present improved the data considerably to conversion from potential donor to actual donor, which is all about the consent. Making it easier for the family at every stage and ensuring the specialist nurses have the data means I expect we could get half the population's data. The UK has failed to do that. Before we conduct a campaign, we will have 38% from the driver's licensing system. Before we advertise, we will, therefore, have 38% of the adult population registered. That is a gift that we must use and it would be a significant lost opportunity not to do it.

The consent systems are the same. It is only a rewording of them. I see no difference and I do not argue about it. I only argue that having a "no" registry on its own is a lost opportunity. We should have a "yes" registry.

I have one more question. It was stated that 80% are shown to support organ donation yet only one third of them carry the card. Is it that they do not get around to doing it?

Mr. Philip Watt

The card has been a very useful initiative. In fact, we would support it going forward as a public awareness initiative. The key aspect of the change is that the expectation is that people would donate. It is a societal shift. That will become the default for society. The expectation is that people will. At the time, God forbid, where there has been a road accident and next of kin are wondering about donation, if those involved from the medical perspective can say that donation is the expectation, it would be an important shift. However, the family can veto it if they want. It will take a few years for that to come through.

Mr. Murphy is arguing for the introduction of the current English system, which the English have now thrown out as they are bringing in a new system. They have an opt-in and opt-out system and, as Professor Egan stated, only 40% have signed up to that. This system means that there would be a much higher percentage of people consenting.

Mr. Robert McCutcheon

When we as a patient organisation speak in a public forum and to transplant recipients, our message is to have the conversation or chat on organisation around the kitchen table. Whether one is carrying an organ donor card-----

Mr. Robert McCutcheon

-----the emphasis is in a family environment to have the conversation.

To make them aware, with which I agree.

Mr. Michael Conroy

I will elaborate a little on Deputy Murphy O'Mahony's question as to whether the soft opt-out option is not the best of both worlds. We think it is the best way forward. The opt-out in and of itself is very important in that it gives a clear option to a person to opt out. The thrust of the legislation relates to consent, and the background to it is the Madden report and issues relating to organ retention and so on. That is very important on the one hand but, on the other, the idea of an opt-in register would have little status. There was a conversation about the donor card, which is very worthwhile but does not have the status of a guarantee. Much of the public thinks it does. Contrary to some of the commentary, we think this legislation, with the publicity that will be needed and which was covered previously, will bring clarity to the public and encourage people to talk to their families.

Regarding the question of how many people might register if there were opt-in and opt-out options and the number of people in the middle who would not avail of either option, we think there is a big fear, shared by a great many people in the donation transplant world in Ireland, that non-registration could sow a doubt in the minds of the next of kin and family members about the deceased favouring donation. Someone might say an option was available to opt in and that the deceased did not avail of it so perhaps that was a purposeful decision. This gives rise to a further element of doubt. That is one of the major reasons we are not in favour of both.

I thank all the witnesses for coming in and I wish Mr. McCutcheon a happy anniversary. I echo what Deputy Murphy O'Mahony said. Part of me thinks we should not have pre-legislative scrutiny on this and that we should just do implement it. I will put my cards on the table. There is cross-party consensus on this, as all parties are agreed on the need for it. I am willing to be corrected on that, but that is certainly my understanding.

I have a few questions. One relates to the kidney sharing scheme. My preference was for the hard opt-out option until I began to look into and read up on it. Perhaps there is a bit of brutal efficiency in me or something. It seemed to me that it would work a little better, but I take on board what has been said. Mr. Conroy mentioned the kidney sharing scheme. Could he take us through what that is, how it works now and how it will change if this legislation goes through?

Mr. Michael Conroy

Is the Deputy referring to non-directed altruistic donation?

Mr. Michael Conroy

At present, living donors in Ireland can donate a kidney to a relative or a person they know well. They cannot give a kidney up for sharing into a pool. In the general scheme, it is proposed that provision will be made for non-directed altruistic kidney donation. This is where a donation is to be made into a transplant pool. There is no direction such as, "I am not giving it to my brother" or "I am not giving it to my wife". The donor is just putting it into the pool for the common good. In this situation, the donor cannot specify the recipient's race, gender or sexual orientation and, therefore, the donor makes the donation as an altruistic action. While everybody around this table is in favour of increasing organ donation and transplantation, we want to ensure we are not unduly hasty in taking organs. An independent panel, which will include psychologists, ethicists and so on, is being set up to improve such donations such that a potential candidate would in the first instance interact with, say, Beaumont Hospital if he or she thought there was a potential there. If things were going in the right direction, the matter would be referred to the panel. The panel would then go through a process to ensure there was no pressure of any kind on the donor and that he or she was in good physical and mental health. These are just safeguards to protect the donor in these situations. Such a process has been used extensively in other countries, including Northern Ireland, which has a successful living kidney donor programme. This will bring us into line with the those countries. We hope it has the potential to increase the number of living donors. We just want to ensure that it is done properly and that no impression is given of pressuring anybody to give-----

I thank Mr. Conroy for clarifying that. I have a friend who is a successful living donor. It is a marvellous thing to do. We need to ensure that the supports are in place for a person who has to take time off work or a person who attends to caring duties in the home to enable them to do this.

That brings me on to my next question, which concerns infrastructure and supports. Let us imagine that tomorrow morning we snap our fingers, the legislation goes through and there is a massive awareness campaign. However, we would not have the infrastructure in place if suddenly there was a massive uptake, and that is very much regrettable. This legislation on its own will not make any changes. I was very struck by the massive increase in the number of families willing to consider donation following a conversation with a specialist nurse. I have represented for some time the transplant nurses in Beaumont Hospital. They are the most amazing people but we just do not have enough of them. They are brilliant at what they do, and I would be happy to put them in front of any family. Nobody wants to have that conversation, but those people are the people to have it. What kind of infrastructure deficit is there? Are skilled personnel available but just not working in this jurisdiction? Are they available and working elsewhere? Would a specific training programme be needed? Are advanced nurse practitioners needed? I am not asking Mr. Conroy to put a figure on the deficit in personnel but I ask him to give us an indication of what is needed. The last thing we want is to do what we believe is a good thing - and God knows precious little of what we do in here is ever perceived as good outside of here - only for it not to be matched by resources once it leaves here. Will he give us just an indication of the resources needed and the lead-in time for them? I refer to the education needed and so on.

Mr. Michael Conroy

Professor Egan will jump in here but I will just give a broad comment first. A living donor reimbursement scheme was brought in in 2014. We have our battles with Mr. Murphy over whether the resources provided will ever be enough, but the scheme has been reviewed twice in the period since. It covers issues such as travel and accommodation-----

Does it now cover people who are caring in the home and who would not have-----

Mr. Michael Conroy


They do not want a loss of earnings.

Mr. Michael Conroy

That was one of the changes made in the most recent review, which was welcomed by a lot-----

It was indeed. It was one I had looked for, having met someone in that position. It was very much welcomed.

Mr. Michael Conroy

Approximately five years ago, we were in a much less developed position than we are now. We are now in a position where we need to develop a lot more. I mentioned in my opening statement the procurement service through ODTI, which was a whole new ball game on that side. We have had a number of developments in the transplant centres in the Mater, St. Vincent's and Beaumont. I will not go into the details, but there have been a number of investments over recent years.

Regarding intensive care, I mentioned the clinical leads and organ donor nurses, but quality officers have been brought in. I tend to think of this in terms of three legs to a stool. We have improved very much on the procurement side. We are reasonably well served on the transplant side. We could do with more resources.

We do not think the legislation on its own will cause a jump in numbers. The combination of all the things we are doing and the publicity will do that. The transplantation service in the three hospitals are reasonable well resourced at the moment but-----

We could do better.

Mr. Michael Conroy

-----we could do better. The bit that is not resourced as well as it could be is the retrieval service because people have to retrieve outside their ordinary jobs. This causes a lot of disruption in hospitals for the people involved and because of knock-on effects on scheduled care, adding to queues and frustration among patients outside the transplant area. The idea is to bring in a dedicated organ retrieval service, made up of people whose first priority will be retrieval. They will work in hospitals in the normal way but when a retrieval opportunity comes up, that will be their first call. There have been tensions in hospitals over this but a dedicated person for this purpose would be a huge step forward. Our hope is that the legislation will bring pressures on us in terms of resources and we recognise that some necessary resources are coming next year.

They will be needed.

Professor Jim Egan

The jewel in the crown is the nurses and the infrastructure to support the family with organ donation. We have made progress since the European directive in 2012 but we are some way behind the UK, which had a human tissue Bill in 2004, 15 years ago. Other jurisdictions have been working on this for a long time and the Spaniards started in 1989. We have got stuck into it in the past few years but we have a way to go. We need at least €2.1 million, in new money, to target organ donation and transplantation. That would be distributed to the specialist nurses and the retrieval teams and would underpin the education of the relevant stakeholders. I do not count the money for the register in this figure, nor that for the public awareness campaign. I am talking about infrastructure money to support those extraordinary families and the extraordinary work that goes on in intensive care units on a 24-7 basis, 365 days a year including bank holidays, August, New Year's Eve and Christmas night, whenever the work goes on. We need an infrastructure that covers 32 hospitals across the country.

What are the figures for personnel?

Professor Jim Egan

There would be about 20 altogether. They would be a mixture of doctors, retrieval surgeons and nurse specialists. Other jurisdictions have invested heavily in this area because there is such a benefit to the health service, particularly in dialysis because we save patients' lives, such as that of Orla Tinsley. We all know about Joe Brolly's altruistic donation and there is extraordinary, but welcome, downward pressure on organ donation rates as road traffic accidents reduce but it is much more complicated than when I started 30 years ago. We need the infrastructure to support the transition from donation to transplant.

Mr. Mark Murphy

Deputy O'Reilly referred to the transplant nurses in Beaumont Hospital. They would not be involved in the organ donation process as it was deemed inappropriate for them to be discussing things with the donor family because they would have a knowledge of who the potential recipients would be. Organ Donation and Transplant Ireland, ODTI, is the resource that will talk to the donor families and the transplant nurses will do their daily job in Beaumont Hospital where, previously, they did the other job too. That is the infrastructure and they were not replaced.

I would imagine they were not. I met a young boy yesterday, Dáithí Mac Gabhann, who lives in the North and is waiting on a heart transplant. It would break one's heart to see his situation - it certainly broke mine. It makes sense to have enhanced co-operation North and South so as to get us into line with the North, and that is not to make a political point. Will such enhanced co-operation be facilitated by this or will it be inhibited by it?

Mr. Philip Watt

The Deputy is absolutely correct. The lung transplant programme in the Mater Hospital for cystic fibrosis, with which I am familiar, is fantastic but at the moment most patients have to go to England, mostly to the Freeman Hospital in Newcastle. This requires travel by aircraft, which is actually dangerous for people with reduced lung function. It makes perfect sense for protocols to be put in place, and hopefully this will happen when Stormont is up and running again, so that the Mater hospital is at least a choice for people. Other people might opt to go to England. Clinicians in Belfast City Hospital in the North would be very much in favour of such a development.

I assure Mr. Watt that nobody is working harder than my party to ensure that happens.

Mr. Philip Watt

Mr. Murphy would agree that co-operation in kidney treatment is also important.

Mr. Mark Murphy

There is a problem, however. A paired programme was mentioned and there is a paired exchange programme that is nothing to do with altruistic donations. Where a husband or wife is not compatible to donate to the other, they can go to the British paired exchange system. In this case, the husband may give his organ to a stranger and the stranger gives his to the man's wife. It is a great system and the British have invited us into the system. They benefit because they get a transplant out of it as well. The system was to move to Northern Ireland about three years ago but it has not been able to do so because there is no one in Stormont to sign off on it. The Irish travel to Coventry and expenses are paid by the Department for the transplant but it would be far easier for everyone if they could go to Belfast, and there would probably be no air travel. The programme there is very successful and we would love it to be available. The idea of a whole-Ireland procurement and transplant service makes so much sense that it will probably never happen. This is nothing to do with Brexit but I do not expect to see it in my lifetime. The EU has very little to do with it, and Brexit also has little to do with the health service. We are not expecting the health service to be interfered with. Our children's hearts, lungs and livers are transplanted in the UK under its deceased donor programmes and we are very grateful for that. There is no expectation that it will change whatsoever.

Mr. Michael Conroy

The paired kidney exchange is one example of co-operation with Northern Ireland. My section in the Department works very closely with colleagues in the Department in the North who are working on the Altnagelvin radiotherapy project. With the same group of people, we organised two workshops which Professor Egan and a number of clinicians and nurses from the South attended.

Both occasions in Belfast and Dublin were very well attended and there was great enthusiasm on both sides around the potential for co-operation. It is certainly something that we are open to and I think they are too. How it transpires over time remains to be seen. Professor Egan may correct me, but I think there have been some patients from Northern Ireland who have had lung transplants in the Mater. There is an openness to sharing and there is potential and it would be very beneficial.

Only kidney transplants are done in the North, they do not do hearts, lungs etc.

I am aware of that. That is good.

Professor Jim Egan

I concur with the sentiment that €6 million in economy of scale is better than €4.8 million. I can testify that we work very closely with NHS Blood and Transplant, NHSBT. It has formally invited us to support its retrieval services in Northern Ireland. Regrettably, we are hampered because we lack the sufficient infrastructure to support that level of activity. The infrastructure for retrieval is very challenging. We have had detailed engagement with Mr. Conroy on this. It is a crucially important goal to achieve.

It is worth noting that the donation rates in Northern Ireland are perhaps the strongest in the UK because it has a very robust publicity campaign. We have met them and sought to learn from what they have done. Mr. Murphy is correct, it is so sensible it probably will not happen. We are working and have shared goals in the area. We have a process around a memorandum of understanding, with Brexit looming, with NHSBT and around the kidney exchange programme. We continue to work on that.

The young boy I spoke of, Dáithí Mac Gabhann and his family have done a huge amount of work. When we met them yesterday, along with the Minister for Health, they were very careful not to attribute any of that to themselves personally. As a neutral observer, however, I acknowledge the work that has been done by the family in particular. They have been indefatigable in their efforts to highlight it and it has had a positive impact on organ donation for which they should be given credit.

Finally, is the register possible without a unique patient identifier or will it be made more challenging, to use a diplomatic phrase, by the lack of one?

Ms Fiona Hammond

The register is entirely possible without the identifier. It is a technical piece of work that would be built so that in the future it could be linked to a unique identifier. The idea that an individual would register themselves is outside of whether an identifier exists or not. It would be outside of the hospital or medical environment.

That is helpful to know. Before I leave, I think we should note the families who, in tragic circumstances, give an absolutely irreplaceable gift. We owe them a debt of gratitude as we do to people such as Nicola McKenna and Enda Fanning who are living donors. Everything we are doing here is to enhance and add to the work that they have done.

Like others, I thank and congratulate the witnesses for their presentations and their responses. The success or failure of any campaign depends entirely on public confidence in how this is done and the degree to which that is satisfied. Professor Egan mentioned the hasty retrieval, responding to a point around the Chairman's donor card - not that we would ever wish that. Following the last speaker's observations, we must be particularly conscious of the donors who in very trying circumstances over a long number of years have made donations. That also applies to live donors.

In the event of an accident, what are the procedures to ensure that there is not a hasty retrieval while living up to the expectations of the legislation?

Professor Jim Egan

The core principle is that we are in the business of saving lives. All the resources that would be focused in trauma are around resuscitating the patient and aiming to secure his or her survival. Clinically, then, the doctors have indicators as to the likelihood of death. Only in those circumstances would folk consider organ donation as a possibility. If the situation is deemed to be futile, then organ donation may be considered.

How long after death does that particular evaluation take place? What is the window within which a decision can be made?

Professor Jim Egan

Our business is very much a process. The death of the brain is defined very clearly according to clinical circumstances. The doctors do specific tests to see if the brain is functioning. They can use additional testing such as CT scans, imaging of the brain and so on to ascertain whether it has functional capacity for the future. That is brain death. It is an uncommon event but might happen if a person fell off a ladder and banged their head. The more common definition of death is when the heart stops. The general public has a greater appreciation of that mode of death. It is only after those events, if I understand the Deputy's question correctly, after the definition of brain death and after the heart stops that the donation process would commence.

That is what is was getting at. It relates to public confidence in the system.

Professor Jim Egan

No, I understand that.

If we do not have public confidence in the system, it will not work. Some years ago, I was a member of a committee in Brussels when there was some animation around the unauthorised retention of human tissue. It caused quite a stir. Returning to public confidence in the system, we must be absolutely certain that these things do not happen because then the system will not work, public confidence will erode and it will break down.

A Bill on human tissue retention, the Title of which I cannot recall, was going through the Houses although it has not yet passed. I think it related to maternity hospitals. That is apropos of nothing other than the issue of public confidence.

Mr. Mark Murphy

The last time the public was shocked was in or around 2001 in relation to the Alder Hey and Bristol hospital cases in Britain, when 30,000 children's organs were found. However, we found organs were also being stored in Dublin. That did rock the public's view of organ donation and the donor card and was damaging. That is the reason for this Act 20 years later. The previous Act, the 1832 Human Anatomy Act, that we are rescinding here had an element of presumption of consent. Now, we are introducing a presumption of consent within this Bill, which I think is dangerous. As a consequence of the old Act, and the retention of children's organs in Dublin maternity hospitals and children's hospitals, we have this Bill some 19 years later.

The legislation was talked about for over a decade. Now, in the legislation, we are introducing a presumption of consent, which we have already found was dangerous and inappropriate. Here we are introducing it again but we are not actually because the wording is a presumption of consent but the practice is not so. We are just worried that the public will get the wrong view. Indeed, it is the confidence of the public that we want to retain and that is why we want the "Yes" and "No" bits included, which fixes the matter for us and restores the public's confidence in this process that we are doing today.

Does the association want a belt and braces provision to deal with the issue that existed before?

Mr. Mark Murphy

It must be belt and braces.

Is Mr. Murphy satisfied that the provision is adequate and sufficient to retain and restore public confidence?

Mr. Mark Murphy

Only if a "Yes" registry is inserted.

Professor Jim Egan

During my contribution I made the point that the European directive in 2012 triggered the deployment of a quality management system. In terms of underpinning public confidence, we have a Government structure. For example, if somebody rings us and says he or she is unhappy with something then we log it, record it, meet our quality managers and we seek to address any concerns that come by way of phone, email or formal complaints and then effect actions to support any imperfections in the system. The process reassures people in terms of public confidence.

There had been a lot of debate on whether the soft opt-out would be a separate piece of legislation. Maybe I am stealing Mr. Conroy's thunder here but we have distinct sections in the legislation to address that so Part 2 relates specifically to transplant.

Mr. Michael Conroy

The piece that has been recalled is on post-mortems and the retention of organs and tissue in the 1990s. I mentioned previously the Madden report and that is the background of a Bill on consent for human organs and tissue, which is covered in this. The provisions about post-mortem specifically covers the issues that appeared at that time. It is separate to transplant and they were linking in with anatomical examination, public display and so on.

On transplants, in the commentary on the ethical importance of consent, which accompanies the World Health Organization's guiding principles on human cell tissue and organ transplantation it states that people should be fully informed of the opt-out system and be provided with an easy means of opting out. That is one of the objectives on the transplant side of this Bill linked to the past - that people will have an opt-out system. There will not be any push on taking organs from a person. We do not want the impression given that that might, at any stage, be done so we want a very clear opt-out where a person can opt out and the family will not be approached. The ODTI representatives can speak more on the details of the register. It is envisaged that there will be a renewal of an opt-out. In other words, a person will be contacted periodically to confirm that that is still his or her wish. It will not be a case of going on a register when one is 20 years of age and maybe having a totally different view at 45 years and forgetting one is on a register and so on.

Are there situations where one must rely on donors from European jurisdictions or vice versa? Do we supply organs to other jurisdictions, depending on the need to find a suitable organ or one that is a match?

Professor Jim Egan

The Deputy has asked a very good question. We have spent a lot of time engaging with our European counterparts and have developed memorandums of understanding, MoUs, with Eurotransplant. Geographically, and because time is very short, when an organ is out of the body we end up working closely with the UK. That goes back to the discussion point about Northern Ireland. The reality is we must work very closely with the UK, particularly around organ sharing. The UK has strengths and weaknesses as do we but we will continue to work with other jurisdictions. Europe is very healthy because it brings a lot of good quality benchmarks to be achieved. We will work both with continental Europe and the UK in that regard.

Will we continue to rely on the exchanges post-Brexit?

Professor Jim Egan

Yes. Again, we have met and discussed with our counterparts how to approach Brexit. We, as medical people, are going to ignore Brexit. Borders do not prevent organ sharing. We will go through due process in terms of paperwork but we will continue to work with folk in the UK.

Mr. Michael Conroy

The issue has been given a lot of thought. The people in the HSE who run the treatment abroad scheme have been in contact and they visited all of the hospitals that interact on organ donation here. There is a willingness on both sides. The technicalities have not been fully worked out but we do not anticipate that there will be a problem in that area post-Brexit.

Finally, I compliment the pioneering surgical teams who have led the fight in this campaign over the years and given a new lease of life to many people. They have also given a sense of purpose and achievement to the unfortunate people who became donors due to accidents or whatever the case. There was something for those unfortunate people where otherwise there might be little satisfaction in the midst of their sorrow. We should recognise and compliment all involved in those particular circumstances over the years and wish them well in the future.

I thank the witnesses for coming in. I, too, pay tribute to the families who have in the most awful of circumstances given the gift of life to complete strangers. I pay tribute to the late Senator Feargal Quinn who championed this case long before it was popular, and long before people were aware of the consequences of not having a functioning organ donation system, which we currently do not have because this legislation is the first legislation on organ donation in the history of the State that is Irish legislation. The only legislation we have was brought in by the European Union, which the head of the Spanish transplant authority said was the worst implementation of the organ donation directive in the European Union. Therefore, we took our one chance but did not do it well for all sorts of reasons that I shall not go into today.

We are now faced with an opportunity to create a better system. We are way behind where Spain was because that country started in the 1980s and even Croatia, which has not been mentioned today. The issue of presumed consent has not been discussed. We had two days of hearings about presumed consent. Everyone walked out the door and said that presumed consent was the way to go and then the view changed to one of presumed consent in addition to which one must ask the families. The latter scared people because people thought Ireland was bringing in the Austrian system that has presumed consent. The option did not work anywhere. Spain brought it in, it did not work and they eventually figured out what works. Information works as do systems that are properly resourced, as Professor Egan and Mr. Conroy have pointed out. One can have presumed consent. One can also have required request, which is in America. I am surprised the option is not in the legislation but it needs to be inserted. The option has been introduced in Wisconsin and other jurisdictions. Professor Egan might answer my next questions. What hospitals have failed to provide organ donors in the last ten years? Has he a hospital in mind?

Professor Jim Egan

No. I would not look at the issue like that.

What hospitals have not provided any organ donors in the past decade?

Professor Jim Egan

They have all provided organ donors, depending on the circumstances.

There is no hospital with an emergency department that did not provide an organ donor. Kenmare hospital did not provide any organ donor. Has any fully resourced hospital with an emergency department not provided organ donors in the past five years?

Professor Jim Egan

Off the top of my head, the answer is "No". Let me make the point that-----

The answer is "No". That is fine.

Professor Jim Egan

It is very difficult to compare and contrast-----

I have been told that certain fully functioning hospitals with an emergency department do not have a system to deal with requests and that such requests are made on an ad hoc basis. The legislation does not address this issue. That is why pre-legislative scrutiny is important. The Bill should have a section to require hospitals to have a system in place. I admit that not all hospitals have the same level of resources. Perhaps Mr. Murphy might enlighten us further.

Mr. Mark Murphy

Not all hospitals can manage an organ donor.

Mr. Mark Murphy

Having an emergency department is not sufficient. The hospital needs to have a bed available in the intensive care unit. I will offer a good example which involves hospitals not too far from the Senator's constituency. The worst year for organ donations was 2010, when there were 58 donors. In that year Bantry hospital had three organ donors, while Cork University Hospital, CUH, had one. Bantry hospital is now incapable of managing an organ donor because it no longer has an intensive care bed. There are differences and quirks. The quirk in CUH has not been repeated. It had never previoulsy had fewer than eight organ donors, but in that year it had one. I went ballistic when it became obvious. The hospital has not had such a low figure since. It was astonishing that a small hospital in Bantry had three donors, while CUH, the second biggest head trauma hospital in the country, had one. It comes down to the individuals working in the intensive care units of hospitals and it is not somehting that will be changed by legislation. The infrastructure must change in order for donation rates to increase.

Mr. Michael Conroy

All hospitals with the required facilities provided organ donors in the past five years. The situation has changed slightly since the appointment of a donation nurse to each of the six hospital groups. One can argue that is not enough, but they have had an impact, on which we hope to build. I agree with Senator Mark Daly that spikes were evident in small hospitals where, obviously, a person was spreading the message of organ donation and it was having an impact.

It comes down to a systems failure. If it is not being measured, it is not being done.

Mr. Michael Conroy

It is-----

I suggest the legislation require the publication of the number of donations made by each hospital. We accept that there are quirks, but it should not come down to the fact that one hospital has an enthusiastic nurse or consultant and another does not. There should be a properly resourced system in place.

Will the position on the issue related to cardiac deaths change under the legislation? Does it need to be changed? Professor Egan referred to brain injury. Will that aspect be provided for in the legislation? Will there be clear guidance for consultants on how it will work or will things be left as they are? It would be helpful if they were. As Mr. Watt, Mr. Murphy and the other delegates are aware, the cost over a decade of people awaiting a transplant is nearly €10 billion, which is big money. How much would be saved if we were to put in place the system Professor Egan, Mr. Conroy and all others in the health service want? We would save millions of euro.

Croatia had a system of presumed consent for kidney transplants and so on, but it did not work. It realised that what was needed was nurses and a system for retrieving organs and transplanting them into people who needed them. That is how we will save the health system money and it should be the aim of every health committee. It is possible to achieve it through this legislation because people wait too long for a transplant under the current system. Does Professor Egan know the number of people who died having been taken off a transplant list because they had become too ill while waiting for a transplant? They died because the system was not working.

My driving licence has the code 115 noted on the back such that my niece will know to donate my organs when my time comes. I will have nothing else to give away. The roles of the committee and the delegates are so important because what matters is what works. The Spanish health service discovered that what worked was nurses who specialised in organ donation. What also works is knowledge, that is, a family knowing that their loved one wanted to be an organ donor. Carrying an organ donor card is one way to impart that knowledge, if one is lucky enough to find it. A person can also discuss the matter with his or her family. If the video of my stating I wish to give away my organs can be retrieved, that is fine.

The system being proposed will not work. The evidence shows - correct me if I am wrong - that 29.8% of families consent to donation without knowledge of their loved one's wishes or being asked to donate by a nurse. The families just offer to donate the organs, which is great. Some 57% give consent if they have no knowledge of their loved one's intentions but are asked to donate by a specialist nurse. That is why we need specialist nurses. That is why they were put in place in Spain. Some 93.9% of families who they know what their loved one's intentions are and are asked to donate consent to the donation. That is the success rate we want to achieve, but the legislation will not bring it about. All it will do is create an opt-out system that will tell the families of people among the 2% to 5% - it is 6% in Wales - who will choose to opt out that their loved one did not wish to be an organ donor. It is a negative measure.

Some 1 million people have indicated on their driving licence that they wish to be an organ donor. I twice asked the Minister for Transport, Tourism and Sport, Deputy Ross, whether he would give that information to the Department of Health. He initially told me that he would not do so, citing data protection concerns. I pointed out that the Department shared the information on persons' driving licences with eFlow, private clamping companies, car parking companies, the Garda, the Courts Service and approximately 15 other organisations, but he was not willing to share it with the Department of Health. He has changed his tune and claimed that the Department of Health does not want the information. The information that would help families to make the decision is often contained on a person's driving licence. It is held by the Department of Transport, Tourism and Sport, but the Department of Health does not want it. If it was handed over such that the family would be aware of their loved one's intentions and they were asked by a nurse to consider donation, it would increase the rate of organ donation to 93.9%. Much of what we can do is available to us, although hospitals need further resources for nurses, which is important. It is a systems failure. The committee should suggest the legislation require the Department of Health to receive the information. If the committee decides to approve the opt-out system, that information should also be available. In potential cases of organ donation, the staff should make one telephone call to discover whether the person had opted out and, if not, another to ascertain whether he or she had indicated on his or her driving licence that he or she wished to be an organ donor. I note Mr. Watt's observation that only 38% people in England indicated their wish to be a donor. However, every inch we can move people along to make that decision will make a difference. I ask that arising from this meeting the committee recommend that the information held on driving licences be utilised. It is available, but the Department of Health does not want it, even though it would help families. All it would take is a simple telephone call to the licensing authority under the Department of Transport, Tourism and Sport.

Mr. Philip Watt

I agree with much of the Senator's analysis. One point on which I disagree relates to the academic research on the issue.

In 2017 the British Medical Journal carried out a systematic review of all published data worldwide to determine whether there was a positive association between opt-out legislation and higher rates of donation. In five methodologically sound studies which compared donation rates in a single country, it found that there had been an increase in donation rates following the introduction of such legislation. Welsh, Scottish and English legislators have all carried out systematic reviews to back their choices to introduce soft opt-out legislation. They have looked at the evidence in that regard. Our colleagues in the Welsh Assembly, the Scottish Parliament and the UK Parliament have looked at the international evidence which clearly shows a positive association between soft opt-out legislation and higher donation rates.

Can I take Mr. Watt back to-----

Mr. Philip Watt

We all accept that it has to be associated with greater resources.

We all agree that presumed consent, a soft opt-out or any other system should not be brought forward without proper resources. The donor audit report showed evidence of the value of the register and the role of specialist nurses, on which we all agree. Does Mr. Watt agree that, if families were informed that their loved ones wanted to be donors, as demonstrated by a driving licence or a organ donor card under the opt-in system, and a nurse asked whether they would allow their organs to be donated, donation rates would increase to 93%?

Mr. Philip Watt

I am of the view that-----

I am just asking whether Mr. Watt agrees with the information we have seen.

Mr. Philip Watt

There is room for the licence system and the organ donor card in the future.

Does Mr. Watt agree that the information we have is correct?

Mr. Philip Watt


What I am saying is this legislation does not-----

Mr. Philip Watt

It is not a substitute for a comprehensive system.

We all agree that specialist organ donor nurses are required.

Mr. Philip Watt

It is an ad hoc system.

It is not a case of one or the other. They are required. We have seen, however, that if families do not know the intentions of their loved ones, the chances of their allowing organs to be donated when asked by a nurse are approximately 57%. If they know that their loved one wanted to be a donor, as opposed to being among the 2% to 5% of people who do not want to be donors, the chances that they will allow organs to be donated are 93%. The legislation does not make any provision for making that information on their loved ones available to families. Am I correct in saying that?

Mr. Philip Watt

That is true, but it is a new system.

No, can I just ask-----

Mr. Philip Watt

The Senator is not letting me answer.

I just want to ask this question. Why does the legislation not provide for what actually works?

Will the Senator, please, give Mr. Watt an opportunity to answer?

Mr. Philip Watt

The system the Senator is suggesting is very similar to the one in place in Britain. It has been shown that only 38% of people sign up to that system, whereas all of the evidence in published research, as demonstrated in the 2017 British Medical Journal review, shows that much higher donation rates are achieved under a comprehensive soft opt-out system. Having organ donor cards and a system connected with the driving licence are worthy initiatives, but they do not and should not replace a donor consent system. That is what we are seeking to have through this legislation.

It is not a donor consent system but just a list of those who have opted out. It does not state who has opted in.

Professor Jim Egan

It is worth reflecting on the fact that in Spain there is no register.

It gave up because it introduced the concept of presumed consent.

Will the Senator, please, let the professor answer?

Professor Jim Egan

The threat arising from having a register is that one ends up talking to the converted and that it will be heavy on resources when they need to be targeted at nursing to increase the levels of education and support provided for families. The other potential threat is that it is unlikely we would have a 100% penetration rate across the population. People are, naturally and appropriately, not in this zone. We have heard informally that in other jurisdictions in cases where people had not put their names on the positive register, their families inferred that they did not support organ donation and that they, therefore, should not go ahead and donate. There are some threats in that system. Let us emphasise again that nurses' support for families and education are the jewels in the crown.

Does Mr. Conroy want to come in?

Mr. Michael Conroy

Professor Egan has more or less covered it. We all accept that a family's knowledge of the potential donor's intentions is crucial. I also accept the Senator's figure of 93%. We accept, as would everybody, that if a person's name was on an opt-in register, in whatever form it would take - moving from one system to another in respect of use of the driving licence would create technical problems, but that is not my point - it is likely that the next of kin would honour his or her intentions, although that would not be guaranteed. The problem is that a large proportion of the population will be on neither one register nor the other, regardless of the means by which the register is run. Many are of the opinion that it could sow doubt in people's minds and potentially lead to fewer donations.

Mr. Mark Murphy

I disagree with that analysis. It is essential to have a "No" registry along with a "Yes" registry. In that way, those who have made a decision would be captured. As the others would not have said "Yes" or "No", one would not be able to say they had said "No". If there were both "Yes" and "No" registers, both options would be available. Using the driving licence does not give an the option to say "No". Therefore, a "No" registry is needed. The two registers should be merged. They should cover both choices. More than 50% of adults in some US states have indicated their wish on their driving licence. Perhaps more Americans than Irish people drive, but it is a fact that the rate has reached 50%. That should be the target. If 50% of the population have made a decision, organ donation rates will increase.

I will ask a question, as we have to finish by 11.30 a.m. On the soft opt-out, which member of the family is designated to make the decision? Is there room for dispute among family members in making a decision? How is the designated family member defined?

Mr. Michael Conroy

A family hierarchy is outlined in the legislation. It starts with the spouse or civil partner. In the event that there is a lack of consensus, part of the work of the organ donation specialist in the hospital will involve trying to bring about consensus. Ultimately, if it is not achieved because, for example, a spouse has one opinion and others have another, the donation will not go ahead.

Is that a potential weakness, or does the decision have to be accepted?

Mr. Michael Conroy

Let us take siblings as an example. There may be a number of them, of whom the vast majority may be in favour of donation. There cannot be any element of coercion, but in that situation every opportunity should be given to the family. Professor Egan may wish to talk about some of the details, but the idea is that there must be no push. However, one hopes they will come to a consensus in favour of donation. There cannot be a push and I do not think it is a weakness. At the end of the day, the Bill is about consent which we must achieve in an agreed format. As Senator Mark Daly said, this is the first time we will have transplant legislation.

Professor Jim Egan

The suggestion has merit. It underlines the importance of training nurses. It is recognised as a potential event, but the core intention is to achieve consensus. In their training specialist nurses role-play that circumstance. It goes back to the system and infrastructure in place. We have people trained to deal with potential conflict and arrive at a consensus, whether positive or negative.

To return to an element of Senator Mark Daly's commentary, is there ever a situation in which a family offers a donation but the infrastructure is not present to allow that to happen?

Professor Jim Egan

The international experience is that there is a laudable downward pressure on organ donation. Donation is now a much more complex process with regard to safety and what might be transmitted, including that the organ would function adequately and whether there is risk of transmission of a malignancy or something untoward in that circumstance. It can happen where a family would wish to donate but on foot of medical complexities, it is not possible to convert that.

Are there times when organs donated here are sent abroad? The legislation should include the required requests system in the hospitals and make sure that the driving licence information that has been captured about people's intentions is used and incorporated into this legislation.

Mr. John Whelan

I have not said anything yet. I have been listening very carefully. I thank the Chairman for a moment to say a word from the patient's point of view. I am a patient, just like my colleague Mr. McCutcheon, and I have been through the system from the inside. I have listened to this debate for the last two hours and heard many interesting points of view. It seems at the end of the day that we are all singing from the same hymn sheet and all have the one aim, which is to increase organ donation. I look back at my experience as a patient. Some 11 years ago, I was called in and a family had been asked the crucial question. The right approach had been made. I went through and here I am now, in perfect health. If my donor had been in a different hospital, the result clearly would have been different if that approach had not been made. It seems to me that all the suggestions that have been made have been useful and constructive but the key one from the patient's perspective is that there must be the right connection in the hospital at the coalface, at the crucial time. If that happens, organ donation will be increased. The infrastructure must be there, with a coterie of properly and fully-trained specialist nurses who are able to communicate with the family. One cannot expect the intensivists or intensive care unit nurses to do it. They do it and what has happened is wonderful but by how much could it be increased if the real specialist nurses were located in all relevant hospitals?

On behalf of the committee, I thank Mr. Michael Conroy and Ms Helen O'Brien from the Department, and Professor Jim Egan, Ms Fiona Hammond, Mr. Philip Watt, Mr. Robert McCutcheon, Mr. Mark Murphy and Mr. John Whelan.

Sitting suspended at 11.32 a.m. and resumed at 11.50 a.m.