Written answers

Tuesday, 17 October 2017

Department of Health

Medicinal Products Reimbursement

Photo of Michael HartyMichael Harty (Clare, Independent)
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277. To ask the Minister for Health if he will direct the HSE to review its decision and the processes used in arriving at the decision not to approve for reimbursement of the drug Translarna for treatment of Duchenne muscular dystrophy in view of the fact that many other countries have given such approval; and if he will make a statement on the matter. [43401/17]

Photo of Brendan SmithBrendan Smith (Cavan-Monaghan, Fianna Fail)
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281. To ask the Minister for Health his plans to make the drug Translarna available through the HSE for persons in view of the fact that this medication is available through the public health system in neighbouring jurisdictions; and if he will make a statement on the matter. [43456/17]

Photo of Michael HartyMichael Harty (Clare, Independent)
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404. To ask the Minister for Health his plans to intervene in 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 in two persons in view of the fact that this legal process will be more costly than providing the drug and may result in these two persons missing their opportunity for treatment; and if he will make a statement on the matter. [44063/17]

Photo of Michael HartyMichael Harty (Clare, Independent)
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405. To ask the Minister for Health if his Department or the HSE will work towards an interim arrangement to treat the persons with Duchenne muscular dystrophy who require Translarna here should a lengthy legal process unfold; and if he will make a statement on the matter. [44064/17]

Photo of Michael HartyMichael Harty (Clare, Independent)
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406. To ask the Minister for Health the reason the HSE’s decision not to reimburse for Translarna was at odds with 22 other European countries; and if he will make a statement on the matter. [44065/17]

Photo of Michael HartyMichael Harty (Clare, Independent)
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407. To ask the Minister for Health if he is satisfied that appropriate negotiations have taken place between the HSE and a company (details supplied) ahead of the company resorting to legal action; and if he will make a statement on the matter. [44066/17]

Photo of Michael HartyMichael Harty (Clare, Independent)
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408. To ask the Minister for Health his views on the fact that a High Court action is the only route of appeal available to a company (details supplied) and the lack of an independent review in the appeals process; and if he will make a statement on the matter. [44067/17]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 277, 281 and 404 to 408, inclusive, 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.

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