Topical Issue Debate

Exceptional Needs Payment Applications

Deputy Bernard J. Durkan

I thank the Ceann Comhairle's office for allowing me this opportunity and I thank the Minister of State for coming to the House to respond. This issue relates to a question tabled on 13 January last and, prior to that, in July of last year as well. It relates to the circumstances of a case in which it was determined that a person in County Kildare did not qualify for an exceptional needs payment following the death of a spouse. The death was preceded by a long family illness, which was obviously a terminal illness. Given that both spouses were in receipt of invalidity or disability payments, they had no other income for a long time. After a protracted illness, of course the family finances were already at a stretch. It was thought that an exceptional needs payment would be appropriate. This is the payment that is now deemed to be available to people who previously would have been able to apply for a funeral or bereavement grant. The application was refused on the basis that the funeral bill had already been paid. Indeed it had, because the person concerned was keen to ensure that she paid the bill. The person made an appeal to other family members, all of whom had their own commitments, in order to discharge the bill. It is expected that the person who paid the bill will have to repay the family members. That is understandable because they gave her help at a critical time. I am asking that this be done and that this case be looked at again in a new light. I know the Department of Social Protection is an excellent Department; I have had experience of it myself. Generally speaking, in 99% of cases, those involved do a thorough investigation and come to a conclusion that is in keeping with the facts. However, I am unsure in this case because not only was the application refused but a subsequent review of the case was undertaken and it was intimated to the applicant that the Department wanted to interview people who had paid or offered a short-term loan facility to pay the bill. I am uncertain about the welfare service. In fact, it was indicated that the Department would seek to ascertain where those involved got their money in the first place and whether they were in receipt of a welfare payment. I was disappointed to learn that because that is not the way the system is supposed to work.

I have no wish to delay the debate this evening. This is an exceptional needs case. I believe that the person is absolutely genuine and has done everything right. The person could easily have not paid the bill and left it sitting there, as many people do, unfortunately. However, she is a very conscientious lady. She paid her bill and would not leave it as a blot on her husband's name by allowing the bill to remain unpaid. Will the Minister of State please examine the matter to see what can be done as a matter of some urgency? This lady is out of pocket to the extent of the amount of money in question since last July.

Minister of State at the Department of Social Protection (Deputy Kevin Humphreys)

Indeed, the Department makes exceptional needs payments in respect of funeral expenses. There is no better Deputy than Deputy Durkan to understand the constraints and the information that it is necessary to provide in this regard.

For some time I have been concerned about the difference in funeral expenses throughout the country. I remember looking at the matter closely. Deputy Durkan's county of Kildare is on the higher band of payments, which averaged €1,853 the last time I looked at the information. There is an opportunity for the next Government to look at the cost of funerals throughout the country.

I believe people are very vulnerable when they lose a loved one. There are inclined to go to the first funeral undertaker or the undertaker who deals with a given town within a given county. The Deputy outlined to me previously how there was only one undertaker who covered a particular part of Kildare, while another undertaker dealt with a different part. There is not always an opportunity, especially when someone has lost a loved one, to go around and ensure that they are getting the right price. It is very difficult if a person has lost a husband or a child to get those costings.

The answer to the specific question was outlined to Deputy Durkan in a reply to a parliamentary question last October. The reply outlined that the person concerned undertook to provide written confirmation of the loan she received to pay the bill. This document remains outstanding to date, but, on receipt of same, a decision on the application can be made.

If additional information or documentation has been obtained, I ask the Deputy to supply it as soon as possible and I will ensure the local officer reassesses the claim.

I again thank the Deputy for raising, through this case, the cost of funerals. Sometimes people, whether they are in receipt of an exceptional needs payment or are paying expenses out of insurance policies or their own resources, can be exploited during what is a very sensitive time.

Deputy Bernard J. Durkan

I thank the Minister of State. A lot of documentation has already been submitted, but it was not acknowledged and I do not know where it went. To be fair to the funeral services in Kildare, I understand about six different undertakers are spread between various towns. They interlink and cross over, which means there is competition. They provide services at prices considerably lower than those in adjoining counties, including Dublin. I would like that to be recognised.

The purpose of the welfare services in this situation is not necessarily to determine the costs incurred by the individual but rather his or her circumstances. If the circumstances need any clarification, what he or she received in the previous year should be taken into account. The person concerned was in receipt of a set social welfare payment, information on which is already in the hands of the Department of Social Protection, and was in receipt of the payment for the previous two years. There were long-standing nursing requirements in the case of this particular person, who was obviously seriously ill over quite a long time, and there were costs associated with that.

I have dealt with many such cases, but I have never dealt with a more deserving case where an application was point-blank refused. If the Minister of State had dealt with the case, he would have felt equally aggrieved. I would like to see an urgent review carried out to ascertain the extent to which the person's actual means were referred to. Suggesting we go elsewhere to find out where the family got the money to pay the bill they felt was a legitimate cost is side-stepping the issue.

Deputy Kevin Humphreys

The Deputy knows the rules and regulations around this. He said a substantial amount of documentation was submitted but he is not quite sure where it is. If the file is with him, he can send it directly to my office and I will ensure a review is carried out. From looking at the information I have, it seems outstanding information was to be provided. If that could be provided, it would certainly help to expedite the case.

I did not mean to reflect on undertakers in Kildare. In his contribution the Deputy said he is aware of undertakers in counties adjoining Kildare which have substantially higher costs. Figures I saw some months ago seem to suggest that is the case throughout the country. Deputy Dowds has on several occasions referred to the cost of funerals and graves in Dublin. At such a time in the life of a wife, husband or family, a person is not inclined to question costs. Rather, he or she is inclined to go to a service with which he or she has a relationship or the undertaker based in the town or locality and pay whatever is asked.

As legislators we have a certain amount of responsibility to protect people when they are at vulnerable stages in their lives and ensure they are not exploited. The next Government should review the issue. I am not suggesting that every undertaker overcharges, but some may be exploiting people during a very sensitive time. Given the difference in the figures throughout the country, there is obviously quite a different spread of funeral costs. If we can protect families in those circumstances, we have an obligation to try to do that. I ask the Deputy to supply me with the file and we will re-examine the case.

Redundancy Payments

Deputy Joanna Tuffy

I wish to raise with the Minister of State, Deputy Humphreys, the appointment of a liquidator to Xtra-vision yesterday and the impact this has had on the staff of the company. It was announced before Christmas that a number of stores would closed and that staff would be let go. Staff understood they would receive their redundancy payments immediately. The appointment of a liquidator means the situation has changed.

Staff are worried about how long they will have to wait before they receive their redundancy payments. I understand some staff learned only yesterday that stores would close and did not have advance notice. It was a major shock for them. The issue has been raised with me and there are other such cases. I am concerned about how staff in such situations are treated. The appointment of a liquidator can lead to fear and uncertainty on the part of staff at a time when they need to be informed in advance of what is happening, told about their entitlements and so on.

I would like the Minister of State to outline the entitlements of the staff in terms of redundancy payments, the timeframe involved and whether anything can be done to expedite their payments. If there is any delay in payments, it could have a major impact on families' outgoings. Will the Department of Social Protection, in particular through local offices such as those in Clondalkin which is based in my constituency where there is a store, make arrangements to give assistance and advice to the staff concerned? Will their jobseeker's allowance claims be expedited in any way or will supplementary welfare payments be made in cases where the need arises? What special arrangements are being made to assist the staff in this situation?

Deputy Kevin Humphreys

I thank the Deputy. This issue arose on Leaders' Questions and the Order of Business today. It is a very difficult time for the staff who have lost their jobs in this manner. My heart goes out to them. It is always very difficult for families when redundancy crosses the doorsteps. I thought of it very clearly today, when I read in a newspaper what had happened to the workers.

My colleague, the Minister for Jobs, Enterprise and Innovation, Deputy Richard Bruton, has responsibility for all matters to do with company law, the appointment of liquidators and the execution of the liquidation process. The priority of my Department is to ensure workers receive their statutory entitlements. Employees who lose their jobs due to the liquidation of their employers are entitled to statutory redundancy payments and other wage related payments due at the time of liquidation. In the first instance, the staff of Xtra-vision who have lost their jobs as a result of the closure should contact the liquidator to ensure they receive their statutory redundancy and wage related payments.

My Department will deal promptly with applications to do with redundancy and insolvency payment schemes in respect of the former employees of Xtra-vision when they are received from the liquidator.

The employees should also contact their local Intreo office where Department staff will advise them on jobseeker's payments and other supports. They will also provide advice and supports on returning to work to all those affected by the closure of Xtra-vision. If the Deputy is aware of individual cases that have fallen through the cracks, so to speak, she should not hesitate to contact the Department directly but I have found that in such cases, the Department reacts swiftly and deals sympathetically with the applicants who are going through a difficult time in losing their jobs. Some of them may have been working for Xtra-vision for quite some time and, therefore, it is a difficult situation for them. Many of them may not be sure of the benefits they are entitled to but the Deputy can rest assured that my Department will respond appropriately.

Unfortunately, within the Dublin region, many of the employees may be located across the city. In rural areas outside Dublin, we can deal with these cases on a one-stop-shop basis but in a major urban area like Dublin, the employees are located across the city and, therefore, it is much easier for them to access their local Intreo office. In the first instance I would encourage them to submit their applications and discuss their situation with the staff in the Intreo office. The Deputy will find that the staff in the Intreo offices will respond appropriately and do everything they can to assist. They will explain clearly all the benefits to which these employees are entitled. We will do our best to ensure that any issue is resolved in a speedy manner but if there are particular issues that are not being resolved or cases of someone falling through the cracks, the Deputy should not hesitate to come directly to my office.

Deputy Joanna Tuffy

As I will not have an opportunity to speak again, I want to take the opportunity to thank the Acting Chairman, the Ceann Comhairle, the staff and the broadcasting services. I wish my party colleagues and all Deputies the best of luck in the future, including in the upcoming election.

I thank the Minister for his reply, which I did not get a copy of, but is there a timeframe in terms of people submitting their application for the redundancy payment? What is the normal timeframe for processing those applications? I appreciate what the Minister said about the individual cases. That should happen in practice but it does not always happen. I know that great assistance is generally given by staff in Intreo offices but can the Minister do anything to raise awareness among staff in the offices closest to the Xtra-vision stores that are closing that there will be a need to give assistance to the former staff of the stores? I accept there are many stores involved but it should be possible to identify particular social welfare offices whose staff could be informed that people will be in need of assistance. It is to ensure there is an awareness among the Department of Social Protection staff that this will happen and to be prepared for it.

Deputy Kevin Humphreys

I thank the Deputy for her question. She can rest assured that there will be an awareness of that within the Intreo offices, certainly of the 350 people who lost their jobs in the Xtra-vision stores. The priority of the Department is to ensure that the workers receive their statutory redundancy and other wage related payments due at the time of liquidation. I give the Deputy an undertaking that we will make sure that the staff in the local Intreo offices across the city are aware of Xtra-vision's situation and we will work as best we can in that regard. I cannot give the Deputy an exact timeframe for processing the applications. Every application can differ slightly in terms of the speed with which the information is provided by the client but she can rest assured we will do everything to speed up the process to ensure they get what are their statutory rights.

Hospitals Funding

Deputy Charlie McConalogue

I thank the Ceann Comhairle's office for selecting this Topical Issue on what could be the last day of the Dáil. It is particularly important that we get the opportunity to discuss it because the news that there is no funding planned as part of the capital investment programme for Ramelton Community Hospital, St. Joseph's Community Hospital, Stranorlar and Lifford Community Hospital is exceptionally concerning.

I welcome the fact funding is to be granted to a number of community hospitals across County Donegal to ensure they are brought up to the Health Information and Quality Authority, HIQA, standards. For example, Carndonagh Community Hospital is to receive €2.5 million, Buncrana Community Hospital is to receive €2.9 million and a new community hospital is planned for Letterkenny to increase capacity. However, it is exceptionally concerning that when that announcement of capital investment was being made by the Minister of State, Deputy Kathleen Lynch, it was made clear that there is no planned expenditure to ensure that the three hospitals I mentioned, namely, Ramelton, Stranorlar and Lifford, can be brought up to the required standard also to ensure they can continue operating as long-term residential nursing care units. I ask the Minister, Deputy Varadkar, to give a guarantee to the public today that they will get the investment required to ensure they can continue to operate.

It is essential that we see capacity increase in Donegal in terms of long-term nursing residential care units. The population of the county is increasing and it is due to increase rapidly in the next few years. Instead of increasing capacity what is planned for in this capital investment plan will see three hospitals being shut down and that capacity replaced by a new community hospital in Letterkenny, which instead should be increasing capacity to cater for future needs.

I have raised this issue to give the Minister an opportunity to give that guarantee to the public in Donegal, in particular to the people who are served by the Ramelton, Lifford and Stranorlar community hospitals, that those hospitals will be protected into the future and funded to ensure that can be achieved.

Deputy Pearse Doherty

I echo what Deputy McConalogue has said. It is important we represent the best interests in Donegal and this cross-party approach is welcome. There is huge fear in these communities as a result of the announcement made two days ago. The announcement of that level of investment should have been positive news in terms of refurbishing the existing community hospitals to bring them up to HIQA standards so that they are able to be licensed post-2021 but it is not a positive news story in certain areas. The community will not stand for the ending of long-stay beds in Ramelton, Lifford and St. Joseph's community hospitals. I want to be clear because we have been speaking to people working within those institutions and communities on the ground and they will not allow an end to long-stay beds in the community hospitals in those areas. We are asking the Minister that instead of generating fear and panic about those three institutions he would confirm to this House that long-stay beds will remain open in those three areas and will not be closed down once the new facility in Letterkenny opens in 2018, which is the projected date.

There is also another problem in Donegal. We are already at peak capacity in the county. I have seen internal documentation within the Health Service Executive, HSE, which refers to people in long-stay beds going into hospital for routine surgery in Letterkenny General Hospital and when their surgery is complete and they have been released from the hospital, their long-stay bed is no longer available. Why is that happening? It is because we are already at peak capacity.

The HSE pointed out to me and to other Members four years ago that we needed 500 additional beds in the county within five years. We are now about a year away from meeting that target. We cannot accept closure of beds and facilities on a county-wide basis that have been operating for many years. We do not want to hear "if", "but", and-or "maybe" from the Minister.

We do not want to hear about rehabilitative or step-down facilities, or respite care in these institutions. What we want to know is that the community hospitals in Lifford, St. Joseph's and Ramelton will have long-stay beds in the future, and those people who call these community hospitals their homes will be there for the foreseeable future, and that people from these areas will not have to travel for long-stay beds in the years ahead.

Minister for Health (Deputy Leo Varadkar)

I thank the Deputies for raising this issue. I am taking the debate on behalf of the Minister of State, Deputy Kathleen Lynch, who is unavailable.

Public residential care units are a significant and crucial part of our services for older people. They provide more than 5,000 long-stay beds, amounting to approximately 20% of the total stock of nursing home beds nationally. The standard of care delivered to residents in these units is generally very good, but we recognise that many of our public units are housed in buildings which are no longer up to modern standards and some are very old indeed. For this reason, Deputy Kathleen Lynch, the Minister of State with responsibility for services for older persons at the Department, recently announced an extensive national programme of investment in public residential units, which will bring them into compliance with national standards by 2021 at the latest.

The plan provides for indicative Exchequer funding of more than €41 million for the counties in the HSE's community health care organisation area one, which include Donegal. A further €38.5 million has been identified for a possible public private partnership, or alternative funding mechanisms in the same area, with details of this to be finalised. The investment will see the provision of two new centres in Donegal, in Ballyshannon and Letterkenny. It will consolidate residential care bed capacity in the county and will provide an additional 25 beds in Ballyshannon. The development of a new 130 bed centre, centrally located in Letterkenny, is intended to ensure that bed capacity in the region, which includes Ramelton, Lifford and Stranorlar, is secured on a sustainable basis.

Given the requirement for additional services to provide for the needs of older people throughout the country, including in Donegal, there will also be an ongoing need for the provision of short-stay beds for rehabilitation, respite, step up and step down, all with a view to keeping older people in their own homes and communities for as long as possible. This is what our senior citizens want in the main.

Over recent years, the HSE has developed and extended community services, focusing in particular on older people who can either be cared for in the community or whose capability can be built up to allow community living. Given the highly developed community services already in place in Donegal, including home care, day care and other short-stay facilities throughout the county, the continuation and expansion of services will be a big part of future service provision in the area. It is in the context of this planning for the coming years that the use and purpose of the buildings in Ramelton, Lifford and Stranorlar will be considered, to ensure that an appropriate service is provided for older people living in their own communities in Donegal.

Deputy Charlie McConalogue

I thank the Minister for coming to the House to take this Topical Issue debate. However, I must say his response is in no way reassuring and leaves very much hanging in the air the scenario of these three hospitals being downgraded and closed. We need to see a guarantee that these hospitals will receive the funding required to ensure they are approved by HIQA and their beds continue to be provided in the local community.

I mentioned earlier how Ramelton Community Hospital has 30 beds, Lifford has 20 HIQA registered beds and St. Joseph's Hospital in Stranorlar has 78 beds. This amounts to 128 beds, and the new community hospital in Letterkenny is expected to have 130 beds. Despite the fact we have an unprecedented growth in our over 65 population, the capital investment plan announced by the Minister of State, Deputy Lynch, will not see additional capacity brought to the Donegal area and will fail to meet demographic demand.

It may have been an accident that these plans were announced during the week as part of the Minister of State's capital investment announcement, but it was no accident the information was there in the first place, indicating the plan is to replace these three hospitals and their beds with a new unit in Letterkenny, rather than to use the unit in Letterkenny to increase capacity in the county.

As we enter a general election, and on the back of what we have seen in recent weeks, with one reheated announcement of future funding after another, funding which was expected and had been announced in the past, what has happened here is that in the rush to put out this information the Government has let the cat out of the bag on its plans not to invest in Lifford, Ramelton and St. Joseph's in Stranorlar. I ask the Minister for a cast iron guarantee there will be investment in these hospitals and they will continue to have the number of beds they have at present so they can continue to provide the essential services they have provided for many years to their local communities.

Deputy Pearse Doherty

I say without fear of contradiction that I speak for the majority of people in the communities when I say they will not accept this. What the Minister has just announced to the House is that these facilities will be considered in the context of planning for short-stay rehabilitative, respite, step up and step down facilities. What the communities want is long-stay beds kept in their area. This is what they want. People have been going to St. Joseph's for generations. It is what is colloquially called the county home. People will not accept this. We have heard spin from the Government that this is not what it means, although the Minister of State, Deputy Kathleen Lynch, made it very clear in her statement that long-stay beds in these three facilities are being replaced by the beds in Letterkenny. The Minister has just confirmed this to us.

I am asking the Minister, who is noted for his straight talking, to explain in plain English that the plan for St. Joseph's, Lifford and Ramelton is not the continuation of long-stay beds. This plan will be resisted. I will resist it, along with communities and front-line services. We need investment in beds. What is the net number of beds that will become available in the county? How will we deal with the crisis at this time where people are being turned away from long-stay beds in the county? People lose their long-stay beds when they go for a simple operation in Letterkenny General Hospital. We cannot afford to close beds in these communities. Will the Minister please listen to my call and the calls and pleas of the communities involved? Will he also spell out in very clear language the plan for long-stay beds in the three institutions in Lifford, Ramelton and St. Joseph's in Stranorlar?

Deputy Leo Varadkar

It is important to acknowledge that the Donegal model of having a large number of community hospitals in the county, with relatively well developed home-care and home help services, is a good model for the rest of the country. In addition to the ten beds provided in Letterkenny hospital, the model has helped us and is one of the factors which have allowed Letterkenny and Donegal to perform so well during this winter period. Letterkenny is one of the few places in the country where hospital overcrowding has reduced substantially on last year, which is evidence of the additional beds working and the strength of the community services.

The Deputies opposite may have the view this is the last ever announcement which will be made on investment in homes for elderly people. This is not the case. This is one announcement, and there will be future announcements in the coming months and years about the services. The points from the Deputies opposite on future capacity were very well made, and there will be need for additional capacity in Donegal and elsewhere. Most additional capacity in nursing homes is now provided by the private sector through the fair deal arrangements, and this is the case throughout the country. What the announcement was about in particular was replacing older facilities and bringing them up to compliance with HIQA regulations. This does not mean there will not be future announcements of future developments and future nursing homes and community hospitals being provided.

Specifically on Lifford, Ramelton and Stranorlar, I do not envisage they will be closed because of the reasons the Deputies stated, namely, rising demand. They will be needed. What will have to be worked out over the coming period is the mix of services to be provided. As the Deputies know, the standards for respite, short-stay and step up and step down facilities are different to those for long-stay facilities. It may very well be the case these units will have to be refurbished to allow them to continue to have long-stay beds and to provide for other needs, such as respite, short stay and step up.

Nobody in the House can give any cast iron guarantees because the Dáil will most likely be dissolved in the coming days and a new Government will be elected.

I cannot give the Deputy any cast iron guarantees, nor can anyone else in this House offer such guarantees about the future with any level of honesty, because we do not know what complexion the future government will have. Suffice to say that what has been announced will be done. It is not intended to close any of these three units, but we will have to work out, in co-operation with the local HSE, how they can best be used and what mix of services will be there in the future.

Medicinal Products Availability

Deputy Robert Troy

I thank the Ceann Comhairle for selecting this important topic today and I acknowledge the Minister's flexibility when I contacted his office earlier regarding this matter. I raise this issue because of a young lady from my constituency whom I know well. Back in 2011, she began to feel ill and to feel a numbness in her legs. Over the past number of years, she has gone through umpteen tests and examinations and many different diagnoses. Ultimately, she was diagnosed earlier this year with Degos disease. It is hard to believe that only a few short years ago this young woman ran the mini-marathon, and now she cannot walk without the aid of crutches. Her husband has had to give up work to act as a full-time carer. The family is more than complimentary of the level of care her consultant neurologist in St. James's Hospital, who has written requesting that the use of this drug be sanctioned in this woman's treatment, has provided. I will read some of the reply the consultant received from St. James's Hospital:

This is a rare life threatening disease and your patient has already suffered significant disability as a result of the disease process. Without effective treatment the likelihood is that your patient will have further central nervous system manifestation of disease such as minor, sub-massive or massive stroke, or may well develop bowel perforation, given that she appears to have endothelial manifestations on the serosal surface of her bowel. Either of these two complications would ultimately lead to her death.

It goes on to state:

[a]s you have reasonably identified, the manufacturer is not prepared to give you any information about "off-licence" use, or of any adverse effects that they may be aware of in this regard. Furthermore, the cost for this drug is prohibitive and would lead to significant adverse effect on the ability of St. James's Hospital to deliver care to very many other patients who are also the responsibility of the Hospital.

I speak quite sincerely to the Minister today. I believe he is a compassionate man. That is obvious from the career he chose in becoming a medical doctor. I have no doubt that he chose that career because he wanted to help people and save lives. Now that he is in an ideal position to help people and save lives, I ask him quite sincerely and genuinely to look at this case compassionately, with a view to sanctioning the care. When a consultant is making a recommendation for a treatment that has the potential to save the life of a lady who is only in her late 40s, we should make the necessary provisions available to try to save this young mother's life.

Deputy Leo Varadkar

I thank the Deputy for raising this issue. The Deputy will appreciate that I am not in a position to comment on the case of any individual patient, even where some personal details are already in the public domain. I have no access to patient records and am not permitted, by law, to make decisions about individual cases.

Soliris, or eculizumab, is an ultra-orphan medicine manufactured by Alexion Pharma and licensed for the treatment of two rare blood disorders. The drug is not licensed for the treatment of Degos disease in Ireland, nor is it licensed by either the European Medicines Agency or the US Food and Drug Administration. The licensing of pharmaceutical medicines is a matter for the Health Products Regulatory Authority, formerly the Irish Medicines Board, in Ireland and for the European Medicines Agency in the EU. It is not in my power as Minister for Health to license any pharmaceutical product. It is appropriate that such matters are dealt with by expert and impartial authorities established for this purpose.

Decisions to use unlicensed medicines are made by health care professionals and their patients through evaluating the efficacy and safety of the medicine and its potential to achieve better patient outcomes. In situations where an individual hospital is asked to approve or support the use of an unlicensed drug, the hospital will rely on professional evaluation of evidence supplied by the treating clinician before making a decision based on that evaluation. In any such evaluation, the health care professionals considering the matter may not support funding the prescription of a particular drug.

Where medicines are used for an unlicensed purpose, this is ideally done as part of a clinical trial. As Minister, I have no role in setting up clinical trials or selecting patients to go on them, and nor should I. In relation specifically to Soliris, in early 2015 the HSE decided to fund the provision of this drug for sufferers of two specific conditions for which it is licensed. At an individual cost of over €400,000 per patient per year, this drug is expected to cost the taxpayer approximately €8 million in 2016. Given these substantial costs, the director general of the HSE has put in place formal procedures to ensure that each case in which Soliris is used is the subject of advance authorisation. These arrangements would not permit the drug to be used for the treatment of a condition beyond the terms of the marketing authorisation and where evidence of clinical benefit has not been demonstrated.

It is open to a drug's manufacturer at any time to submit an application to the European Medicines Agency to have a product licensed for use for a specific indication. Once that drug is approved by the European Medicines Agency, the manufacturer can, if it wishes, submit an application for pricing and reimbursement to the HSE. I hope this clarifies the matter for the Deputy.

Deputy Robert Troy

The Minister knows far better than I that this is an extremely rare disease. I believe there are only 40 or 50 sufferers worldwide and this lady is the only one in Ireland. The Minister said: "[d]ecisions to use unlicensed medicines are made by health care professionals and their patients through evaluating the efficacy and safety of the medicine and its potential to achieve better patient outcomes." The person who is treating this lady is recommending the use of this drug. The patient herself is willing to have this drug tested on her, because I understand six other people in the world have been treated by this. Three of the six are fully recovered, in two cases the disease has been left dormant, and in the final case the delay in administering the drug has resulted in death. My office contacted Alexium, the drug company, which has a base here in Dublin, and it advised of a compassionate drugs access scheme. I would love the HSE to accede to the request by consultant neurologist Dr. Siobhan Hutchinson and make the drug available. Failing that, at a minimum, can the HSE and the Minister and his Department support to the drugs company to fund this under the compassionate drugs access scheme?

Deputy Leo Varadkar

I am advised that eculizumab has been used to treat a small number of Degos patients in highly experimental trials in the US. The results of these trials have been inconclusive, with some patients showing signs of improvement, some getting worse, and one patient dying while receiving treatment. There is no strong clinical evidence or research to support the use of this medicine for the treatment of Degos disease. It is not my decision as Minister to license or authorise medicines and under the HSE governance Act I am barred from making any directions in respect of an individual patient. From what I have read, the case for using this medicine seems very weak. If that changes or if new evidence emerges, it can be reconsidered by the relevant authorities.

I am not familiar with the compassionate access scheme. I will certainly undertake to examine how it works, but I imagine it would have to be based on some evidence that it would be effective in some way. I hear what the Deputy is saying about compassion. One thing we always have to consider in health care is opportunity cost and use of resources. Even in the richest country in the world, resources are limited and if one has €400,000, does one spend it on a drug for whose efficacy there is no evidence or on ambulance or maternity services? We know spending more money on things like ambulance and maternity services would definitely save lives.

The Dáil adjourned at 5.30 p.m. until 2 p.m. on Tuesday, 2 February 2016.

Dáil Éireann díospóireacht - Thursday, 28 Jan 2016