Alan Kelly (Tipperary, Labour)
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67. To ask the Minister for Health when the agreement with a company (details supplied) will be completed regarding the treatment of 19 alpha 1 clinical trial patients; his plans to extend the treatment to all other alpha 1 patients; the timeline for same; and if he will make a statement on the matter. [43846/18]

Alan Kelly (Tipperary, Labour)
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As the Minister will be aware, my neighbour, Ms Marion Kelly, passed away on 1 December last year. She was one of the 21 Alpha-1 patients on the clinical trial for Respreeza. In August 2017, the HSE said that it would not provide reimbursements for this drug. There was then a stand-off for a number of months when two patients, including Marion, passed away having been off the drug for six weeks. There have been many discussions and a number of meetings. The Minister has met the family on two occasions at my request, to be fair to him. However, everything is at a stand-still. What is the status of the negotiations with the drug company regarding this important trial? The 19 patients still on the trial, and others who need the drug, need to know.

Simon Harris (Wicklow, Fine Gael)
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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.

Alan Kelly (Tipperary, Labour)
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I appreciate the honesty with which the Minister has addressed the question. Unfortunately, we have been at this juncture for a long time, and it is frustrating. The Minister met the family in April. We had a commitment from the HSE that there was going to be an agreement on the 19 patients quickly. Meetings were supposed to take place quickly but they did not happen. A meeting took place in June, and there was a follow-up meeting to that. There is frustration that this process has been going on for a year, and we have had no guarantee that these 19 patients will continue on the drug and that it will be administered in the correct way. We need the guarantee. We cannot allow these 19 patients, and those who need this drug, to continue to live in limbo. It is not acceptable. To be frank, the family of Marion Kelly are exhausted; phone calls and emails are not being answered anymore

Simon Harris (Wicklow, Fine Gael)
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I accept that this has been going on for a long time, and I would be interested to hear directly from the Deputy about the failure to respond to emails so that I can pursue that matter. He has separated the two issues. The broader reimbursement issue for patients beyond the 19 on the trial is a matter of, in the first instance, the company submitting an application. I am open to correction, but the information available to me from the HSE is that that has not yet happened. If such an application is received, it will be assessed in accordance with the laws passed in these Houses. The case of those 19 patients on the trial is a distinct issue. I am in full agreement with the Deputy in that regard. I do not believe that people can be on a clinical trial for such a long time with the company then deciding one day to no longer provide the drug. Those people are left in an unenviable and difficult position. I am pleased that progress is being made and that the draft terms of agreement are now in place and with the company for review. As a result of this question, I will check with the HSE on the timeline for the conclusion of the terms of agreement.

Alan Kelly (Tipperary, Labour)
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I do not want to be here in a month asking the same question on the anniversary of Marion Kelly's passing. She died on 1 December, and she was in my office not long before she passed away. This is important for those who are fighting on behalf of the remaining 19 patients. I also acknowledge the work of Deputy Brassil on this matter. He tabled a parliamentary question to which the Minister gave a disappointing response, which is why I am speaking about this matter today. I have also discussed the matter with the Kelly family, which has contacted me on a regular basis.

This must be concluded before the first anniversary of Marion Kelly's death. Has the drug been paid for to date? Have all the administration costs been met? Will the Minister ensure the HSE communicates directly with the Alpha-1 group and with the Kelly family on the current status of the negotiations? I am losing confidence that the people dealing with this from the HSE are prioritising it to the level required.

Simon Harris (Wicklow, Fine Gael)
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I also hope that this can be concluded quickly. On the question of the administration costs, I have no information other than what I have in front of me. The HSE agreed that because of the unique and exceptional circumstances these 19 patients find themselves in, it would fund the provision of the necessary nursing services to ensure patients could continue to receive the medicine. I will certainly check that that has been met because it was the commitment given. It will be honoured. I will also ask that the HSE arranges to meet with the Alpha-1 group and the family of Marion Kelly to update them directly about where this matter stands. I hope that both the company and the HSE can resolve this quickly. I accept that it has been going on for quite a long time. I extend my sympathies and thoughts to the family of Marion Kelly.