Simon Coveney (Cork South Central, Fine Gael) | Oireachtas source

I will commit to talk to the Minister, Deputy Harris, about getting a more detailed answer for the Deputy. I know this is a stressful time for those with spinal muscular atrophy and that patients and their families face enormous day-to-day challenges in dealing with this progressive and life-limiting condition.

On 17 May, the European Medicines Agency granted market authorisation for Spinraza, and in October 2017 the HSE received a reimbursement application. The National Centre for Pharmacoeconomics, NCPE, conducted a full pharmacological evaluation and did not recommend reimbursement at the price submitted. The application is being processed by the HSE. No decision has been arrived at yet as to the statutory assessment process that is still ongoing. The HSE does strive to reach decisions in a timely manner and wants to do so in this case as soon as possible. A total of 23 medicines have been approved for reimbursement to date in 2018, so the Government and the Minister are very anxious to approve the right drugs when appropriate. This approach applies to this drug also. We want to ensure that families and individuals are assisted and supported by the best drugs available on the market. We must ensure, however, that we can access them at appropriate prices to ensure that the benefit that families will get from using these drugs is balanced by ensuring that Irish patients and the Irish State are getting drugs at appropriate prices along with other countries in the EU. This is why the Minister, Deputy Harris, has looked to partner with other European countries to be able to negotiate collectively with drugs companies to get good value for money but also to make the right drugs available on the refund scheme.

I will come back to the Deputy with a direct answer from the Minister regarding approval times.

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