Dáil debates

Tuesday, 28 September 2021

Saincheisteanna Tráthúla - Topical Issue Debate

Medicinal Products

11:05 pm

Photo of Michael Healy-RaeMichael Healy-Rae (Kerry, Independent)
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I thank the Ceann Comhairle's office for allowing this very important issue to be raised here tonight. I have previously raised it by means of parliamentary questions but it is very important to bring the matter to the floor of the Dáil and that the Taoiseach, the Tánaiste, the Minister for Health, the Department of Health and the HSE listen because it is a very important matter. I appeal to the Government to ask that the HSE approve payment for a miracle drug that will help save the lives of two children who are very ill. I am speaking on behalf of, and with the permission of, Lorraine and Daniel Mynard and their daughter, Kate, and Shane and Stephanie Whelan and their little son, Theo. Both Kate and Theo have a very rare muscular condition. These two little children are the only two suitable recipients in this country for this drug, Zolgensma, which is used to treat spinal muscular atrophy, a genetic condition which leads to the loss of movement in the body. It is a gene therapy drug and can vastly improve these children's quality of life and lengthen their lifespans.

Authorities in Ireland have already rejected it on the basis of cost. I do not believe that we should put a price on a child's life at this time or at any time in the future. Other drugs are being administered at present which cost up to €100,000 per treatment. It is obvious that, if this once-off drug is administered, it would be a big help to these children. I must explain that time is of importance because the drug can only be administered to children under a certain body weight and two years is virtually the cut-off point. Michael Clifford wrote a very excellent article in the Irish Examinerrecently in which he highlighted these two cases. I am grateful for that because I want national prominence to be given to this case.

The treatment will help the swallowing muscles. They will be greatly enhanced and improved by the administration of this drug. The respiratory systems of the children would also be helped greatly by this drug. I know the parents would like to thank all of the medical people who have helped them on their journey with their two little children so far. I know they would particularly like to thank the management, staff and people who run Temple Street hospital for the excellent work they have done so far in helping these two little children to have a fighting chance of survival.

I know that €2 million per treatment is a lot of money but whoever said anyone, whether a member of any party or a member of none, or any politician or government, could say that a drug was too expensive to save a child's life? I do not think that is right. At the same time, I am a realist. I understand that there are no blank cheques but - my goodness - we are talking about two little babies who we want to live and who we want to have a fighting chance in this world. We want their parents, their grandparents, their brothers, sisters and cousins to have the benefit of having those young, beautiful children in their lives. I would like to hear what the Minister of State has to say on behalf of the Government.

Photo of Anne RabbitteAnne Rabbitte (Galway East, Fianna Fail)
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I thank the Deputy for raising this matter tonight. I am taking this debate on behalf of the Minister, Deputy Donnelly. I do not know what context the Deputy has or how much he knows, so I will read out the script that has been prepared but I do so while very conscious that there are two families watching us tonight, those of the parents of Kate and Theo, whom the Deputy is representing in raising this Topical Issue matter.

I thank the Deputy for raising this important matter regarding the availability of, and reimbursement for, Zolgensma in Ireland. As the Deputy is aware, the HSE has been given statutory responsibility for medicine pricing and reimbursement decisions under the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies certain criteria for deciding whether the State will reimburse the cost of medicines. These include the health needs of the public, the cost-effectiveness of the drug and total budget impact of the drug. HSE decisions on which medicines are reimbursed by the taxpayer are facilitated by the advice of the National Centre for Pharmacoeconomics, NCPE.

In May 2020, EU marketing authorisation was granted to the medicine Zolgensma for treating spinal muscular atrophy, SMA. The Minister for Health is advised by the HSE that, in April 2020, the NCPE received a reimbursement application for Zolgensma for the treatment of patients with a specific SMA diagnosis. In May 2020, the NCPE completed a rapid review for this application and recommended that a full health technology assessment, HTA, be completed to assess the clinical effectiveness and cost-effectiveness of Zolgensma compared with the current standard of care. The HTA was undertaken as a part of the Beneluxa collaboration between Ireland, the Netherlands and Belgium, with Austria acting as a reviewer in the Belgian procedure. This initiative represents a very positive step in addressing the funding challenges posed by new drugs with very high budget impacts, which are shared by all Beneluxa members.

The joint Beneluxa HTA was completed in May 2021 and it recommended that Zolgensma should not be considered for reimbursement unless cost-effectiveness could be improved relative to existing treatments. Pricing and reimbursement negotiations commenced in July 2021 and are currently ongoing. The purpose of challenging pharmaceutical companies' pricing, through negotiations, is to arrive at a position of value for money. In doing so, we can be confident that public resources are used as effectively as possible to reimburse as many medicines as possible and for as many patients as possible.

The Minister fully appreciates that families want to see their children who suffer from SMA get access to new treatments as soon as possible. However, the Minister for Health has no role in the statutory process under the 2013 Act. The Government's allocation of €50 million for new medicines in budget 2021 has enabled the HSE to approve 32 new medicines or expanded uses of existing medicines to date this year. This has included 12 medicines for the treatment of rare diseases. The Minister nonetheless fully understands that this is a worrying time for the families concerned and is hopeful that the HSE can arrive at a positive outcome with respect to Zolgensma.

I am very conscious that this may not be the answer the Deputy would have wished to hear this evening but, at the same time, it is positive that conversations are still ongoing and that no doors whatsoever have been closed. He can see how the €50 million announced in last year's budget has been spent.

Photo of Michael Healy-RaeMichael Healy-Rae (Kerry, Independent)
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I thank the Minister of State very much. Of course, I appreciate her detailed response but the giant Beneluxa health technology assessment, HTA, we are speaking about was completed in May 2021. We are now into the first week of October. When we are talking about children's health and children's lives, surely the machinery of the State and of the HSE and the dealings with the Beneluxa HTA should be speeded up because of how important this is. We are not talking about trade. We are not talking about selling something commercial. We are talking about a life-saving treatment. That is the difference. Time is of the essence. I have already stated, and I will say just once more, that two years is the cut-off point for these children. If the drug is not administered in their first two years of life, their hopes and their aspirations to have a better quality of life will be very much diminished. We do not want to see that happen with these two little children. I am so glad and so grateful and thankful to God that a little child, five-month-old Arthur Morgan, became the first child in Britain to receive the drug after the National Health Service struck a deal with the manufacturers of the drug with regard to the price. I really am delighted that child was saved over in England but I want to see the Government being proactive on the two cases we have here. I want to see every Member of this House being able to say that the Government did right by those two families because, when a child is born, nobody knows what types of difficulties, whether mental, physical or intellectual, that person will have. Our job in politics is to use the intelligence of those grouped here together to come up with solutions to the problems families have.

I am not just asking. I am pleading and begging the Government to do its best for these two families. I thank the Minister of State.

11:15 pm

Photo of Anne RabbitteAnne Rabbitte (Galway East, Fianna Fail)
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I thank the Deputy again for raising this very time-sensitive issue. I will take on board everything he has said. Before I came in this evening, the Minister reiterated to me that he is hopeful the HSE can achieve a positive outcome concerning the drug. I will ensure he gets the HSE actioned and keeps that continuous engagement and communication open at pace. The Deputy is right that every one of us wants, in our role as public representatives, to get the best outcome for our people and I will do that after leaving here this evening with the Minister, Deputy Stephen Donnelly, on Deputy Michael Healy-Rae's behalf.