Mary Lou McDonald
Ceist:276. Deputy Mary Lou McDonald asked the Minister for Health if the budget necessary to enable the HSE reimburse the drug Translarna will be provided. [42963/17]
Amharc ar fhreagraTuesday, 10 October 2017
Ceisteanna (276, 327, 328, 361, 397)
James Browne
Ceist:327. Deputy James Browne asked the Minister for Health the reason the HSE did not approve the drug Translarna, which would benefit seven children here. [42634/17]
Amharc ar fhreagraJames Browne
Ceist:328. Deputy James Browne asked the Minister for Health if he will engage with the pharmaceutical company that wishes to provide Translarna to those suffering from muscular dystrophy. [42635/17]
Amharc ar fhreagra
John Brassil
Ceist:361. Deputy John Brassil asked the Minister for Health if the HSE will re-enter negotiations with a company (details supplied) with a view to finding an acceptable outcome for the provision of Translarna for the two persons here with an immediate need; and if he will make a statement on the matter. [42817/17]
Amharc ar fhreagraMary Lou McDonald
Ceist:397. Deputy Mary Lou McDonald asked the Minister for Health if he has sought an increased budget for the HSE drug group in 2018 to provide for the reimbursement of the drug Translarna; and if he will make a statement on the matter. [42964/17]
Amharc ar fhreagraFreagraí scríofa
I propose to take Questions Nos. 276, 327, 328, 361 and 397 together.
The Health Service Executive has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE informed my Department of its decision not to reimburse Ataluren (Translarna) in July 2017. The HSE decided not to reimburse Translarna, citing uncertainty around clinical evidence but advised the company that it would be open to reviewing any additional clinical evidence if any should become available. The HSE informed the manufacturer of this decision, in keeping with the requirements of the 2013 Act. The manufacturer has appealed the HSE’s decision to the High Court under Section 27 of the 2013 Act.
As proceedings have now issued against the HSE, this is now subject to the Courts process.
It would be inappropriate for me to comment on a matter currently before the Courts.