Results 5,641-5,660 of 49,836 for speaker:Stephen Donnelly

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?

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

Stephen Donnelly: Whenever the recommendation is sent to the HSE leadership team, is that team the final stamp to say "Yes", "No" or somewhere in between?

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

Stephen Donnelly: I turn now to the process. Professor Barry made a point, on which I fully agree with him, that the State should pay on an outcomes basis for orphan drugs. If there is a drug, be it Spinraza or something else, which works on, say, one in five people, and if it is not cost effective to provide ongoing treatments for all five, we can identify and pay for the one for whom it works while...

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

Stephen Donnelly: I would like to discuss the alleged delay in Ireland in getting some of these drugs onto the market. The witnesses may disagree but it has been put to me by patients, patient advocacy groups, clinicians and the pharmaceutical companies that relative to other EU countries Ireland is very slow in getting the drugs to market. For example, in the case of Translarna, 22 other countries-----

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

Stephen Donnelly: That is fine. It has been put to me by a number of people that Ireland is slower than other countries at getting drugs to the market, for whatever reason. What is being put to me, fairly or unfairly, is that the NCPE moves pretty quickly and is transparent in what it does - whether one agrees or not with the full process that is what happens - and that the EMA at a European level is pretty...

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

Stephen Donnelly: It is the timing of the process that is in question.

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

Stephen Donnelly: On the issue of resources, is Mr. Flanagan speaking about drug budget resources or human resources?

Written Answers — Department of Public Expenditure and Reform: Protected Disclosures (22 Nov 2018)

Stephen Donnelly: 70. To ask the Minister for Public Expenditure and Reform his plans to include private companies in the protected disclosures legislation, including companies providing healthcare services; and if he will make a statement on the matter. [48655/18]

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]

Health (Regulation of Termination of Pregnancy) Bill 2018: Report Stage (27 Nov 2018)

Stephen Donnelly: I would like to speak directly to amendment No. 4. It provides that "No public moneys shall be provided by the Oireachtas to pay for the carrying out of a termination of pregnancy other than a termination of pregnancy in accordance with section 10or 11in a case where there is a risk to the life of a pregnant woman." Let us consider that for a moment. Section 10 is a definitions section and...

Written Answers — Department of Health: Health Services Reports (27 Nov 2018)

Stephen Donnelly: 397. To ask the Minister for Health the status of the implementation of the recommendations of a 2014 report (details supplied) into the genetic department at Crumlin children’s hospital; and if he will make a statement on the matter. [49052/18]

Written Answers — Department of Health: Health Services Staff (27 Nov 2018)

Stephen Donnelly: 414. To ask the Minister for Health the reason there is no specialist in Ehlers-Danlos syndrome employed here; if one can be hired; when they can commence; and if he will make a statement on the matter. [49179/18]