John Curran (Dublin Mid West, Fianna Fail)
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314. To ask the Minister for Health the actions he is taking to ensure that the existing group of 21 persons that are receiving the drug respreeza as part of a clinical trial continue to receive this drug therapy; and if he will make a statement on the matter. [47942/17]

Simon Harris (Wicklow, Fine Gael)
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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 confirmed that scheme would end on 30 September 2017, which was a terrible blow for those patients.

I therefore sought assurances from the HSE that appropriate care arrangements would be 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 they would continue the scheme for six months but since then an issue appears to have arisen with regard to its administration.

I think it’s important to say this access scheme has been run independently and without reference to the HSE.

On 19 October, the HSE contacted the company, seeking a meeting to discuss proposals on the modification of the access scheme and to ensure that the company was fulfilling all of its obligations to the patients who are currently on this scheme.

The company indicated its availability to meet during the week of 13 November 2017, following which we should have a clearer indication about its intentions.