Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I thank the Deputy not just for raising this matter but for his advocacy in this area and for introducing me to the family of Marion Kelly. I have seen first hand, through his work, their dedication to making sure that this issue is resolved for the 19 families. I share that determination. The HSE assessed the application for the pricing and reimbursement of Respreeza and in August 2017, the manufacturer, CSL Behring, was notified that the HSE did not recommend reimbursement.

A number of patients were on an access scheme for this product, operated by the manufacturer. That scheme was being run independently by the manufacturer without reference to the HSE. The company notified the HSE that it had decided to terminate the access scheme from 30 September 2017. The Deputy knows my views on this; I believe it was a very unethical and inappropriate thing to do. Clinical trials involve a duty of care for people, but we have been over that ground previously.

Following interventions by the HSE, the company modified its decision and agreed to continue to supply the medication free of charge for the patients on the access scheme. Due to the critical and exceptional circumstances, the HSE agreed to fund the provision of the necessary nursing service, which does not usually happen, to ensure patients could continue to receive the medicine

The HSE is continuing to liaise with the treating consultant and the company and has now drafted the terms of an agreement for the long-term care of the 19 Alpha-1 clinical trial patients. This proposal is being reviewed by the company and I am informed that a final agreement should be reached shortly. I view this group of 19 patients as separate and distinct. We have a duty of care to these patients because they were on this medication for so long.

On the broader issue of the provision of Respreeza to other patients, it is open to the company to submit a new reimbursement application to be assessed. As the Deputy will appreciate, I have no statutory role in that regard. I understand that a new application has not been submitted.

There are two distinct issues. The first concerns how we look after and care for the 19 patients involved in the trial. I am happy that good progress has been made there. I am informed that a final agreement should be reached shortly and the terms of that agreement have now been drafted, and I am happy to keep in direct contact with the Deputy on that. The second relates to the broader cohort of patients. The company can submit another application on that if it wishes.

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