Leo Varadkar (Dublin West, Fine Gael) | Oireachtas source

I thank the Deputy for raising this important issue. I am fully aware that a number of patients have been on a compassionate access scheme for Respreeza which is operated by CSL Behring. Following recent media reports, it appears that the company could be considering terminating the scheme. However, no formal notification has been received by the HSE from the manufacturer of its intention to discontinue access to the scheme which, as the Deputy said, is unprecedented.

It is completely inappropriate and unethical for any company to link reimbursement decisions to a compassionate access scheme and I would consider it unscrupulous if the company was not to honour any commitments which is it has made to patients. The Minister for Health has directed the HSE to seek assurances from the relevant hospital, that is, Beaumont Hospital, that appropriate care arrangements are in place in the event of the access problem being this continue by the company and that appropriate ethical guidelines has been adhered to for this access programme.

The HSE has carefully considered the pricing and reimbursement of the medicine through its decision-making process and there is insufficient evidence to suggest patients would drive a clinically meaningful benefit from this treatment. At the heart of the assessment process is the rationale that decisions about the reimbursement of medicines in Ireland are made on an objective and scientific basis, taking into account expert opinion, as appropriate, and recognising the health needs of the population and other factors.

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