Billy Kelleher (Cork North Central, Fianna Fail)
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325. To ask the Minister for Health the outcome of the meeting between the HSE and a company (details supplied) in relation to Respreeza; the ongoing difficulties which has seen deterioration in the health of persons with alpha-1; and if he will make a statement on the matter. [49908/17]

Billy Kelleher (Cork North Central, Fianna Fail)
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326. To ask the Minister for Health if measures have now been put in place to allow persons with alpha-1 to receive Respreeza; and if he will make a statement on the matter. [49909/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 325 and 326 together.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act does not give the Minister for Health any powers in this regard.

I am aware that a number of patients were on an access scheme operated by the manufacturer of this drug and that the company had stated that the scheme would end on 30 September 2017.

I therefore sought assurances from the HSE that appropriate care arrangements would be put in place for patients and that appropriate ethical guidelines have been and will continue to be followed for all aspects of the programme.

Subsequent to this, the company let patients know that it would continue supply of the drug for six months but since then an issue has arisen with regard to its administration. This represents a departure from arrangements, which the company had operated for a considerable period of time, in respect of a scheme that was run independently and without reference to the HSE.

I am aware that the HSE met the company last week to discuss the continued operation of access arrangements for the group of patients concerned and I have asked the HSE to keep me informed of developments.