Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
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I call Deputy Ó Caoláin who wishes to discuss with the Minister for Health, Deputy Harris, his continuing refusal to accept the BeNeLuxA initiative concerning nusinersen, Spinraza, now that Ireland has joined the initiative. Is the Minister of State at the Department of Health, Deputy Finian McGrath, taking this Topical Issue Matter?

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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May I ask for clarification on why the Minister for Health, Deputy Harris, is not here? It is less than half an hour since he was sitting in the front row on the Government side of the House, then he left. It is the Minister, Deputy Harris, who should be taking this Topical Issue matter as the Minister for Health. I say that with no disrespect to the Minister of State, Deputy Finian McGrath.

Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
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It is my understanding that when a Minister is not in a position to take a Topical Issue matter, he or she informs the Deputy and a Minister with delegated responsibility-----

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I have had no such courtesy extended to me on this Topical Issue matter. I have been in correspondence with the Minister, Deputy Harris, on this matter and I have engaged with him. I am very disappointed that he has failed to present here this afternoon. I will continue, however. The Minister of State, Deputy Finian McGrath, is a parent. The Minister for Health, Deputy Harris, is not yet a parent, or so I understand.

I hope he will know the joy and the stress of parenthood. I believe he can imagine the distress a parent or parents would struggle with if their child had a life-limiting condition. Despite impassioned appeals, their Government and its agencies refused to make a proven, life-saving drug available to their child. Can the Minister of State imagine if it was his child? There are 25 such children across this State, and they and their parents are suffering grievously. I am reliably informed that some 70 people would benefit immediately if this drug was approved. Spinraza, also known as nusinersen, is a first-of-its-kind treatment licensed in the EU to treat spinal muscular atrophy. Spinal muscular atrophy is a rare neuromuscular disorder characterised by loss of motor neurons and progressive muscle wasting which can be fatal. It is fatal. Only today I spoke with parent who lost a young child and I heard once again the serious pain and hurt that will remain with that gentleman and his family, and many other families, because of the absence of any medicinal support.

The American biopharmaceutical company, Biogen, manufactures nusinersen-Spinraza, but the drug is not available in Ireland. In May 2017 the European Medicines Agency granted market authorisation for Spinraza, and in October 2017 the HSE received a reimbursement application. In December 2017 the National Centre for Pharmacoeconomics, NCPE, completed a health technology assessment of Spinraza and did not recommend reimbursement at the price submitted. The Minister for Health, Deputy Harris, in a reply to me by letter on this issue on 25 September said that he did not have any statutory power or function in terms of reimbursement of medicines. I would ordinarily accept this. However, it is quite clear that the primary obstacle in this instance is price. We have clearly seen this previously with Orkambi and other orphan drugs. Yet again, the patient - and more worryingly in this case - very ill and vulnerable young children - is caught in the middle of a price war between big pharmaceutical companies and the Government.

Significantly, we have been part of the BeNeLuxA initiative since June this year. I do not know if the Minister of State at the Department of Health, Deputy Finian McGrath, will be able to elaborate on the text he has been requested to deliver by the Minister, Deputy Harris, but I have questions to ask now that we are part of the BeNeLuxA initiative. The BeNeLuxA initiative has secured a negotiated arrangement for a significantly reduced provision of Spinraza. We are now in tandem with Belgium, the Netherlands, Luxembourg and Austria. We are part of that grouping, and I want to know if we can now be added to the negotiated arrangement for Spinraza? If the answer is "No", why is this not possible? Has the Department of Health explored joining the arrangement for Spinraza, or endeavoured to establish a new agreement in tandem with either this particular initiative or with other countries? Can the Minister of State update the House today on where the nusinersen or Spinraza process stands and where it is likely to lead us in the short term? We need a result in the short term in this instance.

Finian McGrath (Dublin Bay North, Independent)
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I apologise for the absence of the Minister, Deputy Harris, who is unavailable this evening. I will represent him in this debate. I wish to thank Deputy Ó Caoláin for raising this very important issue. Spinraza is indicated for the treatment of 5q spinal muscular atrophy, SMA, a disorder characterised by progressive muscle atrophy and weakness. I appreciate that this debilitating and progressive condition places enormous pressure on SMA sufferers and their families and carers and that access to potentially beneficial drug treatments is an extremely important issue for people with SMA. Today, I met a family, Paul and Lorraine O'Malley from Mayo, and their lovely daughter, Grace, and I was really impressed by their compassion, sincerity and their urgent need. It is important that I record that in this House.

As Deputy Ó Caoláin will be aware, Ireland signed the existing BeNeLuxA initiative on pharmaceutical policy on 22 June 2018. This agreement is in line with the Minister for Health’s stated objective to work with other European countries to identify workable solutions in an increasingly challenging environment and to secure timely access for patients to new medicines in an affordable and sustainable way. In July 2018, two members of the BeNeLuxA initiative on pharmaceutical policy, Belgium and the Netherlands, completed a joint negotiation for the reimbursement of Spinraza. However, this joint negotiation process commenced when Ireland had just opened negotiations with Belgium, the Netherlands, Austria and Luxembourg with a view to joining the existing collaboration between these four countries. As a candidate country, Ireland was not notified, due to confidentiality arrangements, that negotiations were occurring for the reimbursement of Spinraza, and we were not party to the negotiations and proceedings that occurred.

As the Deputy is aware, 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 the making of 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 the relevant evidence and will take into account such expert opinions and recommendations that are appropriate, including from the NCPE.

The HSE received an application for the reimbursement of Spinraza in July 2017. The NCPE conducted a health technology assessment on Spinraza and did not recommend the reimbursement of Spinraza at the submitted price. The application for the reimbursement of Spinraza is currently being considered by the technology review committee on rare diseases and the HSE drugs group. It is due to be considered by the HSE leadership team shortly, following which the final decisions will be notified.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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The Minister of State's response rehashes much of what the Minister, Deputy Harris, put in his letter to me just a few short weeks ago. There is absolutely no question as to the clinical effectiveness of Spinraza. This is a proven medicine and one that has been granted market authorisation by the European Medicines Agency. It is outrageous that we are going through a process that is independent of an exercise that happened to have commenced before we became members of the BeNeLuxA initiative, and that we are not actively and proactively pursuing access to that arrangement. In the reply the Minister of State has just put on the record of the House there is no answer to my question as to whether Ireland can be added to the BeNeLuxA agreement for Spinraza, and if not, why not? Is the door closed to us for some reason?

What are the terms and conditions of our becoming a member of the BeNeLuxA initiative? Were we not to be a beneficiary state, lining ourselves up with those countries for more affordable access to expensive medication? That is why we joined in the first place, and this is an ideal test of the effectiveness of the decision and the arrangement in place.

Despite the talk of decisions to be notified and processes that are under way, this all comes down to pounds and pence or euro and cent. Children's lives are ticking away as we speak. The Minister of State is quite right. He has met one of those families, as he indicates. He has seen, as I have seen, the huge worry and the strain in the eyes of all those parents. Those beautiful children deserve a better response than the "We will see" answer that the Minister of State offered again today. I urge him to use his position at the Cabinet table, special member of same that he is, to press for this immediately.

Finian McGrath (Dublin Bay North, Independent)
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I do not doubt Deputy Ó Caoláin's sincerity on the issue, particularly on Spinraza as a proven drug. The Minister for Rural and Community Development, Deputy Ring and I are on the same page in that regard. The HSE is the decision-making body on the reimbursement of medicines under the Health (Pricing and Supply of Medical Goods) Act 2013. It is the HSE that will make the final decision on whether Spinraza will be reimbursed, taking into consideration the statutory criteria specified under the Act.

I commend Deputy Ó Caoláin on raising this issue. Paul, Lorraine and Grace O'Malley have a very difficult day ahead of them tomorrow in Temple Street Hospital. I wish Grace well with her operation tomorrow.

Again, there is a moral and ethical debate going on here concerning quality of life cost. Price should never be an issue when it comes to children's health. I urge common sense on this issue. I was directly involved in the campaign at the time of the Orkambi debate. We all rallied around the families affected by that. I accept that the Deputy's views are strong and sincere. I know the families are suffering and I will bring all the issues raised back to the Minister, Deputy Harris.