Results 2,941-2,960 of 3,998 for speaker:Michael Harty
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: The Deputy may ask a supplementary question later. I must allow other members to contribute. I have another question. What is the manner of engagement with patient groups because such groups feel they are not being engaged with in a meaningful manner? What about representative organisations and specialists in the field where the drug applies, who feel they are not being engaged in a...
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: Is there engagement where people are spoken to across a table?
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: I thank Deputy Durkan. I invite Mr. Hennessy to lead off in replying to the questions.
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: We are going to have to move on. There were some other questions. Perhaps Mr. Flanagan would like to go through those.
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: There was a question about who in the HSE makes the decision when it goes from the NCPE.
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: On that point, have drug price negotiations taken place with the company producing Translarna and are they still ongoing?
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: Okay. Deputy O'Connell also asked about free pricing in Germany and what happens after the year. How do they manage if the drug is not been found to be effective?
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: A vote has been called in that Dáil. However I am going to remain in the Chair and we have some Senators who will remain so the meeting will continue. Some members may need to go.
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: We will bring Deputy Brassil in as soon as possible.
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: Sorry Senator Burke, we do have a lot of speakers who have not got in yet.
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: Can Senator Burke park that answer for the moment? We might go through the situation in Germany. We will suspend the questions of the Deputies who have left and bring in the questions of the those who have not spoken yet.
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: There were some questions that we might just park for the moment because the Deputies who asked them have left relating to FDA and marketing policy in the US, different standards of assessment for orphan drugs, drug pricing negotiations which I think Professor Barry referred to and duplication of evaluations. We will leave those and bring in other members who have not had an opportunity to...
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: I will continue.
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: Yes, absolutely.
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: I am sure we will.
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: Well, five minutes for the questions and ten minutes for the answers perhaps.
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: Yes, if we are not happy we will interrupt.
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: I have one supplementary question. Have any orphan drugs been authorised in Ireland on a conditional basis?
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: Can the witness speak about the EMA context?
- Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)
Michael Harty: What is the situation in Ireland?