Brendan Smith (Cavan-Monaghan, Fianna Fail)
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435. To ask the Minister for Health if persons currently using respreeza will not be denied access to this medication; and if he will make a statement on the matter. [41869/17]

Simon Harris (Wicklow, Fine Gael)
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I am aware that a number of patients were on an access scheme operated by the manufacturer CSL Behring. The HSE has advised my Department that the manufacturer has confirmed it will no longer fund the drug with effect from 30 September 2017 and that the access scheme is discontinued.

I consider this action by the company as unethical and as I have stated previously, there should be no link between compassionate use schemes and reimbursement decisions. It is the responsibility of both the company and the investigator (clinician) to ensure that they have considered and made arrangements for the patients, including in circumstances where the product is not reimbursed by the HSE.

On my request, the HSE has sought assurances from Beaumont hospital that appropriate care arrangements are in place for patients who were on the access programme, 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 advised that this process is ongoing.

The HSE has also advised that it has decided to continue with the provision of this treatment to this patient cohort only, for an initial period of two weeks.