Dáil debates

Thursday, 14 November 2019

Saincheisteanna Tráthúla - Topical Issue Debate

Medicinal Products Availability

4:10 pm

Photo of Seán Ó FearghaílSeán Ó Fearghaíl (Ceann Comhairle; Kildare South, Ceann Comhairle)
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The first Topical Issue matter, which will be taken by Deputies Lisa Chambers, Ó Caoláin and Curran, concerns the roll-out of Spinraza since its approval in June. We have rarely heard as much in the House about any topic.

Photo of Lisa ChambersLisa Chambers (Mayo, Fianna Fail)
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I mean no disrespect to the Minister of State but we expected the Minister for Health, Deputy Harris, to appear in the Chamber to answer questions from me and Deputies Curran and Ó Caoláin.

5 o’clock

He has been on notice since Tuesday when this Topical Issue matter was first submitted. It was a reserved Topical Issue matter yesterday. I live on the other side of the country and I can be here for this debate. We will raise this matter again and demand that the Minister, Deputy Harris, present himself in the Chamber to answer questions. It will be well noted by the families and children waiting that he is not here.

The availability of the drug was announced in June. To date, only three of the 25 children who need Spinraza have received it. The HSE and Minister are fobbing families off and hiding, thinking they will get away with it.

I am helping Grace O'Malley, a child who lives in my constituency. She was told in no uncertain terms that she would have the drug by the end of October and to hold on. She has now been told that she is a special case because of a spinal rod in her back, something which is no fault of her own. She will now have to wait until next year. A new team will be needed and a new service will have to be put in place, and funding will need to be applied for in order to put that service in place. What does it say to a child like Grace who has no control over her ailment that she now has to wait? When will Grace and the other children receive this drug? When will the money be made available? We need a timeline and a date.

4:20 pm

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I agree that the Minister, Deputy Harris, never presents himself to be held accountable by the House. The announcement that Spinraza was to be approved by the HSE should have afforded the families of children living with spinal muscular atrophy, SMA, hope, respite and a chance to plan for the future. Many of the families affected came to Leinster House and stated with great dignity the impact that the denial of Spinraza has had on their lives, and a number have been forced to return.

Since 11 June, the continual denial of Spinraza to many of these children, now perhaps due to administrative and resourcing reasons, is having the same devastating impact on these children and their families. The headline of 11 June is not the endgame. If we are to go on the suggested data that only a small number of children currently have access to Spinraza, quite clearly the Government is failing children with SMA. I want a clear answer as to the number of children currently in receipt of Spinraza and why it is the case that not all of those who are entitled to the opportunity to see if the drug will make a difference in their lives are currently receiving it.

Photo of John CurranJohn Curran (Dublin Mid West, Fianna Fail)
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Sam and Glen are two boys who live in Rathcoole and Clondalkin. They and their families were delighted and full of hope last summer when it was agreed that Spinraza would be made available to them. They had the realistic expectation that the drug would be administered to them over the summer holidays, but it was not. All hope has been withdrawn from them. There is no date for when it will be made available to them and they are very upset. They were thrown a lifeline which has now been taken away.

A month ago I asked the Minister how many children had received the drug and at that point in time none had. I understand that perhaps three children have now received it. We have raised this issue in the House, and have been fobbed off and told it is a complex condition and so forth. All of those facts were known last summer when the decision was made to make the drug available. The children were identified last summer; it is not as though new children have appeared.

The reality is that somewhere along the way there is a disconnect between the health service which is administering the drug and the decision made by the Government which we all welcomed. We want to know how many children are currently in receipt of the drug. When will all of the remaining children start on the drug? We do not want to be fobbed off with references to this being a complex issue and so forth. We all know that. We want the decision of the House and Government to be implemented immediately.

Photo of Finian McGrathFinian McGrath (Dublin Bay North, Independent)
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I thank Deputies Chambers, Ó Caoláin and Curran for raising this important issue. As far as I am concerned, I am taking this matter on behalf of the Minister, Deputy Harris, who sends his apologies. I will not fob anybody off.

I fully recognise that spinal muscular atrophy places considerable strain on SMA sufferers and that families are anxious to see their children who suffer from this debilitating and painful condition begin treated with this medicine. In June 2019, following a thorough review process and engagement with the manufacturer, the HSE leadership team approved access to the drug Spinraza for children with SMA types I, Il and Ill on an exceptional and individualised basis.

The actual patient assessment and approval process is the means for determining access on an individual case by case basis to this complex and expensive treatment. Since July, 11 children have been approved for Spinraza treatment in Temple Street Hospital. Application for approval is based on clearly defined criteria and clinical guidelines being followed in each case.

Spinraza is injected during a procedure known as lumbar puncture. The actual delivery of this drug to approved patients in a safe and sustainable way requires very specific and quite complex service arrangements to be put in place. There are two categories of patients with regard to the administration of Spinraza. For category l, where the administration of Spinraza is deemed not too technically difficult, a consultant paediatric neurologist and lead clinician need access to the day ward as administration is performed under local anaesthetic. Each of these patients will also require a physiotherapy assessment pre-administration and recovery time in the day ward.

Category II are more complex patients who have already undergone spinal fusion surgery and insertion of spinal rods, which makes the administering of Spinraza potentially more complex. For these patients, the delivery of Spinraza will require specialist care to include input by an anaesthetist and an interventional radiologist with associated nursing and the availability of capacity in the paediatric intensive care unit.

It will be appreciated, therefore, that a considerable amount of service planning and assessment of patients at an individual level is required in order for treatment with Spinraza to be undertaken. The HSE has confirmed that the provision of auxiliary services to facilitate the administration of Spinraza to these patients is currently being worked on.

The Minister, Deputy Harris, has been advised by the HSE that four children are now receiving Spinraza, three of whom were successfully started on Spinraza treatment in Temple Street on 7 November. The HSE has also confirmed that Children's Health Ireland, CHI, is in discussions with colleagues across the three children's hospitals in Crumlin, Temple Street and Tallaght with regard to arranging a schedule so that administration of Spinraza can be performed for approved patients. As part of this process, CHI is engaging on an individual basis with the families involved regarding each child's treatment plan.

Furthermore, the HSE has indicated that a meeting has now been scheduled between CHI and the SMA Ireland advocacy group at the end of November to discuss arrangements for the delivery of Spinraza. The Minister, Deputy Harris, has asked to be kept updated on any further developments. I will bring any of the concerns raised to date back to the Minister immediately.

Photo of Lisa ChambersLisa Chambers (Mayo, Fianna Fail)
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With all due respect, why is the Minister of State here to tell us what the Minister, Deputy Harris, has been advised? Surely he should be here to tell us what he has been advised.

The suggestion that administering the drug requires complex service arrangements is not new. I was told this many months ago by the children waiting for this drug, who knew all of this in advance. We knew about this before June. We have been told today, following approval of the drug last June, that the HSE is currently working on the facilities to administer the drug. What comfort and reassurance does that give to any child waiting on the drug? Three of the four children receiving this drug only started on it this month.

Why was the drug approved to great fanfare last June? It seems that the Minister, Deputy Harris, is quite keen to get the stress and pressure off his back. He will say whatever he needs to get out of a sticky situation. Making announcements of that nature, getting people's hopes up and then not delivering on them is cruel.

We in the House want to know when the Minister became aware that a new service and team would be required to administer this drug. When will the budget be made available to administer this drug? When will the remaining children receive Spinraza? We want a date and timeline, not more broken and empty promises and no delivery.

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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With respect, after the passage of so many months we are facing into Christmas and for the greater number of these families there has been no real delivery.

I noted from the reply that the Minister of State has read into the record that 11 children have been approved. He went on to clarify that only four have actually been lined-up, and perhaps even only three are currently in receipt of the drug. There is an uncertainty in regard to this.

I wish to put on record that I understand and appreciate, as the families do, the wonderful trojan work that Dr. Declan O'Rourke, the prescribing specialist doctor for spinal muscular atrophy, SMA, children at Temple Street Children's University Hospital, is doing. He and the hospital are denied the infrastructure and support in order to carry out a much greater throughput of those at least 11 children initially. We need to see all the children given the opportunity for trial to see how Spinraza will work for them. Pray God it will make a difference for them all. That would be the hope of all of us, as it would be of the families.

I ask the Minister of State to reflect the frustration and vexation of the Members of this House to the Minister for Health for the failure to move this forward with the speed that it requires and his failure once again to be accountable to this House on this particular important matter.

4:30 pm

Photo of John CurranJohn Curran (Dublin Mid West, Fianna Fail)
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The Minister of State and I go back a long way but this is an appalling answer; it really and truly is. I know he is delivering it for the Minister for Health and that it is not his role, but this is absolutely shocking. These parents had the realistic expectation that within a number of months of having the drug approved, their children would be in receipt of it. This is a degenerative condition. Each child today is in a poorer condition than they were last summer. This drug should have been administered by now. The Minister of State set out the two scenarios for the two types and he indicated for category 1 that it required access to a day ward. Surely to God in this country, in this day and age, we can have access to a day ward to administer this drug to these children.

Even the more complex cases should have been dealt with by now. I note that the Minister of State has made a strong point of saying that three children were treated on 7 November. I wonder if we had not brought to the floor of this House back in October that no child to October had received the treatment, would any children be receiving it now. We are not satisfied with this answer.

The Minister of State can tell the Minister that Members of this House and colleagues will continue to raise this issue until we get a straight answer. What we want to know, without talking about the complexity of the case because this was all known back in June, is when will all of those children receive their initial doses of this drug, Spinraza. Are there other issues going on behind the scenes that we are not aware of? Is the budget in place or is the Department trying to defer it until next year? Honest to God, the families and the children, in particular, are aware that their condition is deteriorating. We have to do better for their expectations and hopes. I hope that the Minister of State's supplementary answer is more positive, detailed and specific because we will bring this issue back to the House.

Photo of Finian McGrathFinian McGrath (Dublin Bay North, Independent)
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First, there is nothing else going on-----

Photo of Lisa ChambersLisa Chambers (Mayo, Fianna Fail)
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Yes, there is nothing going on.

Photo of Finian McGrathFinian McGrath (Dublin Bay North, Independent)
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-----behind the scenes. As far as I am concerned I fully recognise this is a very important time for patients, their families and carers.

As to the answer to the question, 11 children have been approved for Spinraza treatment in Temple Street Children's University Hospital and four patients have received the treatment of the medicine to date. Three of these started on 7 November at Temple Street - this is the key sentence - but there is no definitive timeline for the schedule of treatment for more complex cases. What I am saying is that the complexity of this treatment requires appropriate service arrangements to be put in place in Temple Street Hospital to ensure that the treatment and delivery of this medicine is conducted in a safe and sustainable way, appropriate to the standard of care that has been developed for the particular treatment. While I hope that access to this treatment will be provided shortly for all concerned, it is important to note that I or the Minister, Deputy Harris, have no role in relation to how clinicians manage the care of individual patients. All decisions are entirely a matter for the treating clinician, in line with the patient safety protocols and guidelines, which are currently being developed by the HSE to administer Spinraza. I will of course bring the issues raised by the Deputies today back to the Minister, Deputy Harris.

Photo of Seán Ó FearghaílSeán Ó Fearghaíl (Ceann Comhairle; Kildare South, Ceann Comhairle)
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The second important item is from Deputy-----

Photo of Lisa ChambersLisa Chambers (Mayo, Fianna Fail)
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On a point of order, a Cheann Comhairle, is the Minister required even to explain as to why somebody is here to deputise for him or are Members of this House supposed to just accept when somebody just does not bother to turn up? We are all here, is that-----

Photo of Seán Ó FearghaílSeán Ó Fearghaíl (Ceann Comhairle; Kildare South, Ceann Comhairle)
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I will explain. It is completely appropriate for a Minister to delegate a Minister of State from his or her own Department to take a Topical Issue matter. There is nothing unusual about that. If Deputies are unhappy, they can register a complaint with me on the answer, or lack of-----

Photo of Lisa ChambersLisa Chambers (Mayo, Fianna Fail)
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The lack of an answer.

Photo of Seán Ó FearghaílSeán Ó Fearghaíl (Ceann Comhairle; Kildare South, Ceann Comhairle)
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-----availability of the Minister and we will attempt to assist.