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Minister must seek fast track of EMA assessment process for Nusinersen – O’Reilly

17 January, 2017 - by Louise O'Reilly TD

Sinn Féin Health Spokesperson Louise O’Reilly TD has said that the Minister for Health Simon Harris should seek a fast track of the assessment process for the drug Nusinersen in the European Medicines Agency (EMA). She said that with two lives in Ireland alone waiting for the assessment to complete, this is a case of life or death.

Deputy O’Reilly said:

“Only two babies in Ireland have been diagnosed with SMA 1 and an application to the European Medicines Agency was submitted in September-October 2016 for the drug Nusinersen for the treatment of this.

“However, in a PQ response, the HSE have advised me that it could take up to one year for the assessment process to conclude. It is only then, if a European market authorisation is granted or about to be granted, the HSE would expect to receive a pricing and reimbursement application from the manufacturer. What this means is a protracted and drawn out process for two babies whose lives are under threat.

“The HSE have advised me that it only expects to receive a pricing and reimbursement application during the middle of 2017 and the drug then must undergo an assessment by the NCPE here. In a situation where time is of the essence, this protracted process must be sped up where possible.

“We do not wish to predetermine the outcome of any assessment, either by the EMA or the NCPE, however a decision must be made urgently. In a situation where the Foods and Drug Administration (FDA) approved the US market authorisation in December 2016, parents are anxious that the assessment process be concluded here, so that they may access lifesaving and critical medicine for their sick children.

“It is important that the Minister work with the EMA to seek a fast track of the assessment process for Nusinersen so that domestic procedures can be triggered here. We are not requesting that the process be interfered with in terms of its outcome, only that there are no delays so that the NCPE can act swiftly in their assessment, thus giving greater certainty to parents.” 

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