Paddy Burke (Fine Gael)
Link to this: Individually | In context | Oireachtas source

I welcome the Minister for the Environment, Community and Local Government, Deputy Hogan, to the House.

Fidelma Healy Eames (Fine Gael)
Link to this: Individually | In context | Oireachtas source

The Minister, Deputy Hogan, is very welcome. My request to him is to ask the Minister for Health to outline the criteria used to determine the eligibility of children with rare life-threatening cancers and other illnesses for financial support from the Health Service Executive in order that they may be included in clinical trials in foreign jurisdictions. Moreover, if this is not possible, the Minister for Health should outline the reason. It is with some regret that I note the Minister for Children and Youth Affairs, Deputy Fitzgerald, has left the Chamber given this issue also would fall within her remit.

Considering the recent passing of the children's referendum and its purpose to put children first, it is important to explore every opportunity for life, for saving lives and for the health care of our children in foreign jurisdictions, particularly children with neuroblastoma. The Minister may have heard of a little girl called Lily Mae Morrison, who is four years of age, is from Claregalway, County Galway, and who suffers from stage 4 neuroblastoma. Her parents are Judith Sibley and Leighton Morrison, both of whom are self-employed professional ballet dancers. Neuroblastoma is a rare childhood cancer of the nervous system affecting one in 100,000 children, primarily under the age of five. Between six and eight cases per year are reported in Ireland and while the prognosis for survival at stage 4 is poor, a number of treatments are available in Ireland through the HSE that improve the survival rates of sufferers. The treatment takes two years and involves chemotherapy, radiotherapy, surgery, stem cell harvesting and rebuild and it involves many inpatient and outpatient visits. At the end of the treatment, there still is a 70% chance of relapse and the treatment options in Ireland after relapse are limited, the most common option being palliative chemotherapy. A number of clinical trials for treatments for relapsed neuroblastoma are under way, one in the United States and another in Germany. These trials indicate an improved survival rate of more than 50% for those children availing of the trials.

The cost of the trials are between ¤500,000 and ¤750,000. There are anecdotal accounts of adult cancer sufferers, in particular those suffering from brain tumours, being facilitated by the HSE with financial assistance to go on clinical trials in foreign jurisdictions for cancer treatment. Could the Minister confirm if that is the case and if so, why they would be extended to adults and not children? Is it not the case that all cancer treatments are trials by their very nature, whether or not approved by the HSE for treatment. What trials are going on in this country that could help and what partnerships exist, if any, between Irish hospitals and other EU jurisdictions that could assist children with neuroblastoma?

In the United States in 2009, a total of $5.6 billion in funding was spent on cancer research. The sum of $3 million went towards research on neuroblastoma. The average life person years lost due to neuroblastoma is 67 years. The average loss for breast cancer is 16 years, which illustrates that neuroblastoma is a particularly aggressive form of cancer.

Lily Mae has become a national treasure. The Minister may know of her. She has been on every media outlet and her story has been covered extensively by the Irish media on television, radio and in print, including ?Nationwide?, ?The Late Late Show?, the ?Craig Doyle Show?, ?Ireland AM?, "Midday", ?The Afternoon Show?, and by theIrish Independent and the tabloid press. The campaign behind her has recorded the song "Tiny Dancer" ? she is a tiny little girl ? the song by Elton John and Bernie Taupin, who both endorsed her campaign. That is an indication of the extent of people she has reached. She has a weekly following of more than 450,000 people. On average, more than 45,000 people engage with her story on a daily basis either liking, sharing or commenting on a story on her page. It has been shown that 52% of fans are aged between 24 and 44 and two thirds of them are female. She is building up a considerable following. This is now a national story.

To date, the campaign supporting her treatment is somewhere in the region of ¤50,000 but it is not just about the amount of money raised, which is significant; it is about the value of the media coverage the charity single has garnered for neuroblastoma and the increased awareness of the disease it has created in this country and internationally. The beneficiaries of the project are the Sunni Mae Trust, established to help with the care and future medical needs of Lily Mae and the Neuroblastoma Society, a United Kingdom-based charity established by the parents of children with this disease or those whose children have died of the disease that endows neuroblastoma research with financial support in order to promote the discovery of new treatments and potentially a cure for the disease. I have deliberately put all of that on the record. This is a serious case that touches the lives of many people in Galway and across the country, in particular the four-year old girl. It affects six to eight little children every year in this country. I await the Minister?s response.

Phil Hogan (Carlow-Kilkenny, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank Senator Healy Eames for raising this matter. The notice of the matter received did not refer to a specific individual case. If that had happened I would have expected to have been briefed on the individual case. She asked about the criteria which the Department of Health and the HSE use to determine the eligibility of such children as Lily Mae who have rare life-threatening cancers. The Health Service Executive operates a treatment abroad scheme, TAS, for persons entitled to treatment in another EU or EEA member state or Switzerland under EU Regulation 1408/71, as per the procedures set out in EU Regulation 574/72, and in accordance with Department of Health guidelines.

Within these governing EU regulations and the Department of Health's guidelines, the TAS provides for the cost of approved treatments in another EU or EEA member state or Switzerland through the issue of form El12 (IE). A decision is made on each application in accordance with this legislation and guidelines and on the basis of a review by clinical experts. The cost of the treatment is not a deciding factor when approving an application. The treatment must not be available within the State or not available within a time normally necessary for obtaining it.

The TAS allows for an Irish-based consultant to refer a patient that is normally resident in Ireland for treatment in another EU member state or Switzerland, where the treatment in question meets the following criteria: First, the application to refer a patient abroad has been assessed and a determination given before that patient goes abroad. Second, following clinical assessment, the referring consultant certifies a recommendation that the patient be treated in another EU-EEA country or Switzerland; the treatment is medically necessary and will meet the patient's needs; the treatment is a proven form of medical treatment and is not experimental or test treatment; the treatment is in a recognised hospital or other institution and is under the control of a registered medical practitioner; and the hospital outside the State will accept EU-EEA form El12 (IE).

The application to refer a patient abroad must be assessed and a determination given prior to the patient availing of the treatment abroad. Valid applications will be processed within 15 to 20 working days and a decision will be issued via letter. Appointments should not be scheduled prior to a decision being reached on an application. Appointments that are made prior to a decision will have no bearing on the review process or its expedition.

The response sets out the criteria in terms of who is eligible under such a scheme. Perhaps the person the Senator has brought to the attention of the House is eligible under the scheme outlined, but I am not in a position to determine that as I have not been given the necessary briefing. The Senator might wish to bring the details to the attention of the family involved and explain to them the precise procedure to be followed. No applications to the scheme have been accepted for referral for inclusion in clinical trial and current practice is that costs associated in participation in a clinical trial are borne by the providers of the trial. Applications to the scheme are only accepted where the patient, adult or child, are being referred outside the State for proven treatment that cannot be obtained within the State.

Fidelma Healy Eames (Fine Gael)
Link to this: Individually | In context | Oireachtas source

I appreciate the information the Minister has provided. We are aware of the scheme. It is not about treatment, it is about a trial. That is the difference. Germany is within the area and there appears to be a trial there that is producing improved results that would not be available to the child in this jurisdiction. The question is whether the trial could be considered a treatment because it would give the child improved results.

Phil Hogan (Carlow-Kilkenny, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I ask Senator Healy Eames to give me the information she has at her disposal and I will talk to the Minister for Health about the matter tomorrow and get an assessment of the individual case carried out. I was not aware the Senator was inquiring about an individual case as she did not indicate that in her question. Therefore, I could not be expected to have a reply on the matter this evening. I will undertake to speak to the Minister for Health tomorrow and get an answer on the individual case concerned.

Fidelma Healy Eames (Fine Gael)
Link to this: Individually | In context | Oireachtas source

I am grateful for that.

Paddy Burke (Fine Gael)
Link to this: Individually | In context | Oireachtas source

We are not on Committee Stage.