John O'Mahony (Fine Gael)
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The Minister of State at the Department of Health, Deputy Catherine Byrne, is welcome.

Aodhán Ó Ríordáin (Labour)
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I thank the Minister of State for being here. I very much appreciate it and I know she will feel strongly about the issue I am about to raise. I also appreciate that her Department is working as best it can to find a resolution to the issues I raise. I welcome in the Gallery Ms Fiona Bailey, the mother of Sam Bailey. I met the family of Grace O'Malley from Mayo last week.

Last week there was demonstration outside the Dáil, of which I think the Minister of State was aware, about the 25 children in this country who suffer from spinal muscular atrophy type 2. It called on the Government to speed up the process of making the wonder drug, as it is called, Spinraza available to these children. It is a vitally important intervention that these children greatly need. What the families are asking for is the exact timeline for negotiation between the HSE and Biogen, the manufacturer of this drug. The Minister for Health, Deputy Simon Harris, who I know is engaged in this issue and seeks a resolution of it, tweeted last week to one of the parents involved in this campaign that the issue is currently with the HSE, that there needs to be engagement between the HSE and the company, that he will make sure it happens and that he knows how important it is to families.

What the families are really asking for is clarification as to where the process is. It is understood that Biogen made an offer on 29 July and that a high-level meeting on the issue may be held in the Department tomorrow. Spinal muscular atrophy type 2 is a particularly difficult condition to live with. The families are doing their absolute best and they appreciate that there are people working in the Department who are doing their best to ensure we can come to a resolution of this issue. I know from my time as a Minister of State in that Department and from working in these Houses that no one in politics tries to be a blocker or to increase the suffering of children. The 25 children are doing well but, having spoken to their families last week and again this morning, I understand they fear facing into winter, even at this time of year. The impact winter could have on children with this condition is frightening.This drug could make all the difference. It is freely available in 20 countries in Europe, but for some reason, two do not, one of which, unfortunately, is Ireland. We know the process and campaign the Government went through to find a solution for children with cystic fibrosis in the case of Orkambi. It was much appreciated. I think it is within the Minister of State's capacity to give the families affected by this condition some hope. They want clarification of where the Government is in negotiations with the company. Can we hope and expect Spinraza to be freely available for the children in question in that they can look forward to having more complete lives and fulfilling their potential?

Catherine Byrne (Dublin South Central, Fine Gael)
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On behalf of the Minister, Deputy Simon Harris, I thank the Senator for raising this matter.

Medicines play a vital role in improving the overall health of Irish patients. Ensuring access to new and innovative medicines in a timely manner is a key objective of the health service. The challenge is to deliver on the objective in an affordable and sustainable way. However, new medicines are often very expensive. There is a large number of applications in the reimbursement process which, if all approved, would have a significant impact on an already overstretched health budget.

Spinraza is indicated for the treatment of 5q spinal muscular atrophy, SMA, a disorder characterised by progressive muscle atrophy and weakness. The Minister understands access to potentially beneficial drug treatments is an important issue for all people with serious illnesses and fully appreciates that SMA sufferers and their families face enormous day-to-day challenges in dealing with this progressive and debilitating condition. The Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013 which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion, as appropriate. The Act specifies the criteria to be applied in making reimbursement decisions, which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources available to the HSE. In reaching its decision the HSE will examine all of the relevant evidence and take into account such expert opinions and recommendations as are appropriate, including from the National Centre for Pharmacoeconomics, NCPE. This ensures reimbursement decisions are made on objective, scientific and economic grounds. The NCPE is a team of clinicians, pharmacists, pharmacologists and statisticians who evaluate the clinical benefits and costs of medical technologies and provide advice for the HSE. NCPE reports are important inputs to assist the HSE in its decision-making process. The HSE received an application for the reimbursement of the drug in question in July 2017 and referred it to the NCPE for advice. The NCPE conducted a health technology assessment of Spinraza and did not recommend reimbursement at the price sought by the applicants.

I make it clear that the HSE has yet to make a final decision on the pricing and reimbursement application submitted by Biogen for the reimbursement of Spinraza and that the statutory process is ongoing. The HSE is the decision-making body for the reimbursement of medicines under the Health (Pricing and Supply of Medical Goods) Act 2013 and will make the final decision on whether Spinraza will be reimbursed, taking into consideration the statutory criteria as specified in the 2013 Act.

Aodhán Ó Ríordáin (Labour)
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I appreciate the answer and the fact that the Minister of State has outlined the process involved, but what the families really need to know is when it will happen. I know that the Minister of State may not be in a position to give me that answer now, but I ask her to impress on the Minister the importance of this matter. I understand the HSE has yet to make the final decision, but I think the Minister of State appreciate that the families listening to this debate, including a mother who is in the Visitors Gallery, want to know when it will be made. Will the Minister of State impress on the Minister the importance of the matter? Is he in a position to meet representatives of the families? Will he give an assurance, as he did, in fairness, through social media last week, that he cares passionately about it? Will the Minister of State ask him for clarity on the timeline involved? That is what the families really want. While they appreciate that negotiations are ongoing, that there is a cost issue and that these matters are technical and complicated, the issue is of critical importance to the children. Will the Minister of State impress on the Minister the importance of meeting the families to outline the timeline involved? We cannot live off an answer that a final decision has yet to be made, with no sense as to when it will be made. As a compassionate politician, the Minister of State will appreciate this. I ask for clarity on the issue. I know that the Minister will listen to the Minister of State and wants to engage with the families to bring the matter to a successful conclusion.

Catherine Byrne (Dublin South Central, Fine Gael)
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I say to the Senator and the parents that I do not believe any of us in this Chamber or elsewhere wants to see seriously ill children suffer. The Minister is true to his word. He has said he will fix this problem and I believe that will happen. The timeframe is crucial for everybody present. I did not know about the meeting with the Minister. I will inform him that the Senator has raised the issue. Sometimes the cost of a drug should not be an issue when it comes to life-changing medicines for children. I adhere to all of what the Senator has said. I will convey what he said in his contribution to the Minister this afternoon.