Micheál Martin (Cork South Central, Fianna Fail) | Oireachtas source

Last Friday, with Deputy Billy Kelleher, I met a group of Alpha-1 patients who were on the drug Respreeza and who told us their stories and individual case histories. From 2006 onwards they had been part of a clinical trial involving the drug, which slows down the progression of emphysema in patients with severe Alpha-1 deficiency. From 2010 onwards they had been part of a compassionate access programme which had been ceased by the company, CSL Behring, in September 2017. Following discussions the company made the drug available again, but the HSE refused to administer it. There was an unedifying impasse and in the intervening period two patients, Anna Cassidy and Marion Kelly, died. A compromise was then reached. It will last until May. All of the patients I met had been on the drug for years. All had reported the benefits of the drug for them, to which their families testified. I met Marion Kelly's sister, Niamh. Marion had been the youngest of the cohort of patients who had benefited hugely from Respreeza. Niamh Kelly said that when Marion had come off the drug, she deteriorated rapidly. All of the patients I met had deteriorated rapidly once they had come off the drug. Anna Cassidy and Marion Kelly should never have died. That they did is a very sad reflection on all concerned - the company, the Government and the service provided. They died while there was an unedifying row taking place and the drug was lying in a warehouse. A third party is administering the drug as part of the compromise reached.

There are articles in The Lancetand The Lancet Respiratory Medicinewhich confirm the efficacy of the drug in slowing down the progression of emphysema in the cohort of patients in question. In the United States 6,000 people are on Respreeza, while the authorities in Germany, France and large parts of Italy reimburse the cost. As the European Medicines Agency has approved the drug, why has Ireland not done so? Professor Noel G. McElvaney in Beaumont Hospital has been the lead clinician in this area for quite some time. Why do we ignore his expertise? He is the only European member of the Alpha One Foundation. The Minister for Health has said he wants engagement and asked the HSE to engage with the company. It has not engaged. There has been no engagement. Will the Government intervene to ensure a physical meeting will take place between the company and the HSE to have the issue resolved and ensure reimbursement will take place? That is the only way the matter can be resolved. If it is happening all over Europe and the United States, why is it not happening in Ireland?

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