Billy Kelleher (Cork North Central, Fianna Fail)
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684. To ask the Minister for Health the steps he will take regarding the unprecedented High Court appeal brought by a company (details supplied) against the HSE decision not to reimburse for translarna for the treatment of Duchenne muscular dystrophy for two children; and if he will make a statement on the matter. [45957/17]

Billy Kelleher (Cork North Central, Fianna Fail)
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685. To ask the Minister for Health if his Department or the HSE will work towards an interim arrangement to treat children with translarna; and if he will make a statement on the matter. [45958/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 684 and 685 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, in deciding not to reimburse Translarna, cited uncertainty around clinical evidence but advised the applicant that it would be open to reviewing any additional clinical evidence if any should become available. The HSE informed the applicant of this decision, in keeping with the requirements of the 2013 Act. The applicant has appealed the HSE’s decision to the High Court, which is part of the statutory process 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.