Clare Daly (Dublin Fingal, Independent)
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165. To ask the Minister for Health if he will meet with a person and a group (details supplied). [44435/17]

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.

In relation to the access scheme for Respreeza, the operation of such schemes is at the discretion of manufacturers. As Minister for Health I have no role in the operation of these schemes. There is no provision in Irish legislation for the approval of compassionate use programmes for specific groups of patients with an unmet medical need.

On my request, the HSE has sought assurances from Beaumont hospital that appropriate care arrangements were in place in the event that the access programme is discontinued, and that appropriate ethical guidelines have been and continue to be followed in relation to all aspects of the clinical trial and access programme.

The HSE has informed my Department that they have received a letter from the company in relation to their Compassionate Access Programme and other issues. The HSE is carefully considering the communications and will be engaging further with the company in relation to the full details of their proposals.

I have asked the HSE to contact you directly to update you on this matter following the completion of this process.