The postponement this week of the decision on the funding of the drug Spinraza to treat spinal muscular atrophy (SMA) has been condemned in the Dáil.
Fianna Fáil deputy leader Dara Calleary said "some faceless unanswerable operation is not taking a decision and is not taking action".
He said it was time for politicians to take charge rather than “some unanswerable body playing with these families’ futures”.
But Tánaiste Simon Coveney said Mr Calleary knew the process and it was not politicians who made the decision on what drugs were or were not permitted to be paid for by the State.
“We have created timelines over and over again whereby families have built an expectation around decisions and that decision hasn’t been finalised,” Mr Coveney said.
He understood the concerns and frustrations of the families and the Minister for Health Simon Harris also wanted the issue sorted.
There was a “back and forth with the company” on the issue and he too had expected a decision but it would now take longer.
They could not change the position because of frustration around the process to move from the HSE making a decision to politicians “making a decision in a potentially political and inappropriate” way, Mr Coveney said.
Mr Calleary said however that the Minister for Health had already bypassed the process in the provision of another drug.
“This process is broken when nobody is answerable to public representatives and families,” he said.
Twenty five children and adults suffer with SMA and a decision was expected on Tuesday about the funding of the drug which on Wednesday was approved by the NHS in Britain.
Ireland and Estonia are now the only two EU members which do not fund the drug.
Mr Calleary said he had first raised the issue in September and he told the Tánaiste that “you sympathised with children and families. You said it was a priority and nothing has happened.”
The Mayo TD said he had raised the issue again five months ago, three months ago and a number of TDs from a number of parties had raised it but without success and “every single day matters” to people affected.
The 25 families affected had been repeatedly told the issue was a priority but had been repeatedly let down.
Mr Calleary said the number might take away from the people involved who included “Grace, Kilian, Sam and many other children and adults who are going through hell”.
He implored the Tánaiste to go on Facebook and see the message from Grace O'Malley that the decision had been kicked down the road again.
Mr Coveney said “it’s not like the HSE deliberately wants to delay these drugs”. The HSE was in negotiation with the company.
He pointed out that the HSE approved 23 new medicines and five new uses of existing medicines at an additional investment of €175 million.
“We need to be careful that we don’t set a precedent that switches a decision making process that is based on critical assessment and make it a political decision when it should be a medical one.”
