I wish to raise the life-threatening decision taken by the drug company CSL Behring. It is withdrawing the Respreeza drug at the end of September. It is a most serious situation facing 21 people who are citizens of the country. Their health will go into decline at the end of September if this vital drug is taken away from them. It is immoral.

I am not blaming the Taoiseach, the Department or the Minister for Health. Will the Taoiseach use his influence? In no other country in Europe or the rest of the world would patients who are dependent on a life-saving drug have it taken away from them. If I am wrong about that, I would like to Taoiseach to correct me. I understand there is no precedent for this happening anywhere else. I ask the Taoiseach to address this most important matter.

I cannot call on another Deputy on a matter that has been raised by one of the party or group leaders.

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.