Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I thank Deputies Brassil and Kelly for raising this issue, not just on the floor of the Dáil but on many occasions over the last number of weeks and months and for keeping in close contact with me directly on the matter. Like both Deputies, I express my deepest sympathies to the families of the patients who have recently passed away and offer my condolences and, I am sure, all our condolences at this difficult time. I cannot begin to imagine what those families must be going through.

As the House will be aware, a number of patients had been on a Respreeza access scheme operated by the manufacturer for a number of years until that company decided abruptly earlier this year to end the scheme for all patients on 30 September 2017. This access scheme was not one which had been established with the HSE's involvement. It had been directly established by the company. Nonetheless, I asked the HSE to satisfy itself that arrangements were put in place for the continued appropriate care of the patients concerned. I asked the HSE for the appropriate care because I am not a clinician and it is the responsibility of the health service to ensure there is appropriate care, and the HSE then engaged with the company over a number of weeks. I understand that the company agreed to continue to supply the medication free of charge for the patients who had been on the access scheme for a further period of six months, or until a further clinical trial commences next year. However, the company was not willing to continue to cover the cost of administering the medicine to these patients. The HSE, having considered all the circumstances, has decided to facilitate a transition arrangement under which it will fund the provision of the necessary nursing service to ensure that the treatment of patients can resume. I have often been critical of the HSE but I will say on the record of this House that I have seen the HSE work extraordinarily hard to try to come up with innovative solutions. It has sought meetings with the company to engage with it over a sustained period. The Health Service Executive did Trojan work to try to put in place an arrangement to get this drug flowing to patients again. I deeply regret the circumstances that happened in the intervening period.

The new transition arrangements will facilitate the immediate resumption of the administration of the drug to the affected patients and will continue until a further clinical trial commences in 2018. The company anticipates that approximately half of the current compassionate access group of patients will be recruited into the next clinical trial in 2018. The terms under which the HSE has agreed to fund the administration of the drug include a requirement that the lead clinician concerned ensures that appropriate alternative treatment regimes are put in place in good time for those patients not proceeding to the next trial. The HSE has agreed to fund the nursing service to administer the drug during the next six months because the company firmly refused to fund further administration of the drug in the period to mid-2018 when the next trial is due to begin. However, factually and legally, that decision does not in any way alter the position regarding the HSE's formal decision not to reimburse Respreeza.

I assure Deputy Brassil that the Health (Pricing and Supply of Medical Goods) Act 2013 gives the HSE the power to decide whether or not to fund a drug and its drugs group comprises ten clinicians. This is looked at from a wide range of areas. The HSE has previously considered the pricing and reimbursement of Respreeza through its decision-making process. I would say to the company and the HSE that they should not squander these six months and should continue to engage further. It is open to the company to produce more evidence, more information and to negotiate further. That is what should happen. We should not have a company that has total ownership of the access scheme with no HSE involvement ending the scheme in an abrupt manner, leaving Irish patients high and dry. I do not want to engage in the blame game against the company or the HSE, since the matter is too important, but the company has obligations as well as the HSE. I am pleased that arrangements have been made to resume treatment for patients which will allow a safe period of time but my appeal today is not to waste that time and to ensure there is further engagement with the company and HSE, and I will work with colleagues on this.

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