Mr. John Hennessy:

I will try to address the points made earlier on Respreeza and alpha-1 patients. I appreciate the difficulty these patients find themselves in at present, but the fact remains the application for the reimbursement of Respreeza did not pass the effectiveness tests we have in place. It was considered that the health technology assessment process and the expert group reviewed the evidence. What was demonstrated were marginal clinical improvements but coming at a very high price. At the end of the process, the decision was that it was not cost-effective and the decision was not to reimburse. That does not mean treatment is not available for these patients. Of course there is conventional treatment available at all times.

On the compassionate access situation, to be clear on this, the HSE was not involved in establishing the clinical trials or the compassionate access program and cannot become involved in it now without drifting into a contradictory position of declining the application for reimbursement and then becoming involved in the administration of it. However, we do feel those involved in the trials and the compassionate access programme have a duty of care to those patients and have a duty to manage those patients properly and appropriately. We do not accept that making deadlines and setting new deadlines repeatedly is helpful in the process. We would like to meet the company to discuss its approach on the management of those patients in particular. I do not accept it is a cost issue. It is a substantial multinational company. There are and have been arrangements in place for the provision of this treatment for those compassionate access patients for many years, and we will call on it to continue this, at least until we have a chance to discuss its arrangements for the orderly and appropriate management of those patients. A meeting has been arranged, which is scheduled to happen next week. It might have been out there that it was to be on 13 November, but it is the week commencing 13 November. I hope to be able to make further comment at that stage and understand better what the company's arrangements are for those compassionate access patients.