Leo Varadkar (Dublin West, Fine Gael) | Oireachtas source

I know this is a very stressful and worrying time for people with spinal muscular atrophy and their families. I know the day-to-day challenges these people and these patients face in dealing with a progressive and life-limiting illness. It is important to say that this is not a political decision. Deputies should note this if they do not know it and I hope they do not tell anyone otherwise. It is not a case of anyone hiding behind bureaucracy. It is the law. This is not a political decision. Politicians do not sign off on which drugs are reimbursed and which are not.

The European Medicines Agency granted market authorisation in May 2017 and in October 2017 the HSE received a reimbursement application. The National Centre for Pharmacoeconomics, which is an independent expert body made up of doctors and pharmacologists, conducted a full pharmacoeconomic evaluation and did not recommend that the drug be reimbursed due to efficacy and cost. The application is being processed by the HSE's national drugs committee. No final decision has been made as yet and it is always open to the manufacturer to produce new evidence or a different cost profile that would allow the drug to be approved. So far this year, 23 new medicines have been approved for reimbursement.

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