Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein) | Oireachtas source

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.

See this speech in context