Results 44,181-44,200 of 49,836 for speaker:Stephen Donnelly

Written Answers — Department of Health: Cancer Screening Programmes (22 Nov 2018)

Stephen Donnelly: 158. To ask the Minister for Health if the figure of 221 women being adversely affected by the CervicalCheck issues is accurate; and if he will make a statement on the matter. [48806/18]

Saincheisteanna Tráthúla - Topical Issue Debate: Cancer Screening Programmes (21 Nov 2018)

Stephen Donnelly: Am I going to get an answer to the specific questions I asked?

Saincheisteanna Tráthúla - Topical Issue Debate: Cancer Screening Programmes (21 Nov 2018)

Stephen Donnelly: I have great respect for the Minister of State, Deputy Jim Daly, and my comments are not a personal criticism of him. In deputising for the Minister for Health, Deputy Harris, the Minister of State has been consigned to reading out what is written on a piece of paper. This is topical issues and is meant to be a Dáil debate. The Minister for Health could have emailed me this response....

Saincheisteanna Tráthúla - Topical Issue Debate: Cancer Screening Programmes (21 Nov 2018)

Stephen Donnelly: The Minister of State will be aware of a case that has come into the public domain in recent days, namely, the tragic case of a woman who developed cancer after she was incorrectly given the all clear by a genetic test at Crumlin hospital. She is calling for a full review of diagnostics at the hospital. She has also asked that a panel of experts in genetic medicine from outside the State be...

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: I thank the witnesses for their time today and, more broadly, for all the work they do. The advocacy work and the pressure and technical expertise they bring to the table are incredibly valuable. I realise they can feel they are ploughing a lonely furrow for much of the time so I wish to acknowledge all the work they do on behalf of many men, women and children throughout the country. They...

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: I have a question on that. I was going through the process on this last week and the view I got was that the clinical evaluation is quite open and moves at a decent clip. The National Centre for Pharmacoeconomics, whether one agrees or disagrees with what it decides, arrives at a recommendation quite quickly. It has its €45,000 per year measure, with which we can agree or disagree,...

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: Specifically on evaluation, one of the issues in passing these rare drugs is that they do not meet this magic number of €45,000 per quality-adjusted life year, QALY, or a disability adjusted life year, that rare drugs are not meeting. This is for several reasons, including the lack of comparator therapies to use, because they are very expensive due to the small numbers of people to...

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: I thank everybody for coming before the committee this morning. It is very much appreciated. I thank them for all the work they do and this is clearly a very sensitive and important area. I have various process questions as to how things are being improved. I will first ask about both Spinraza and Translarna. With Translarna, an application was received in September and yesterday we got...

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: I thank Mr. Hennessy. On the affordability side, the question for the parents and children is when they can expect to get a "Yes" or "No" or a half-yes or any answer on this in order that they might be able to access the drug.

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: That is by the end of this year.

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: It will be in the next six weeks.

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: I thank Mr. Hennessy. The Spinraza process has been ongoing for some time. In May 2017 it was approved by the European Medicines Agency and an application was received in October last year. In December last year we were told the National Centre for Pharmacoeconomics, NCPE, completed its health technology assessment and said "No" at the current price. My understanding is we have a "Yes" on...

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: No, I am not.

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: I am not asking for a guarantee on the approval of the drug. I hope the HSE can negotiate a price where it is approved, and we all hope that happens soon. As we are all acutely aware, because we are all trying to achieve the same thing, SMA is a degenerative disease and every week and month matters. I am cognisant that the NCPE refused the price that was offered 11 months ago. Some 11...

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: That is helpful. If we assume the best and final offer was made by the pharmaceutical company, although that can change, can the HSE not give the parents a broad outline? It sounds as though the negotiations have concluded and it is now a question for the State. Surely we should then be able to indicate how long the State will take to make these decisions.

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: I am not asking Mr. Flanagan to do that; I am just looking for timelines. If it is discussed, and if it gets onto the December agenda, is the drugs group the deciding body or does it go back to another body?

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: The meetings are held every month.

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: It could be that it is on the agenda for-----

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: If it is put on the agenda for the drugs group for December, a recommendation one way or the other, or potentially somewhere between, will go-----

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (21 Nov 2018)

Stephen Donnelly: Yes. That recommendation would then be sent to the HSE leadership team, which would discuss it at a January meeting. Is that how it works?