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Leaders' Questions (9 Nov 2017)

Louise O'Reilly: At the end of September the European Medicines Agency in London held a public hearing on the epilepsy drug sodium valproate, better known in Ireland as Epilim. The purpose of the hearing was to consider whether the warning against taking the drug while pregnant was strong enough. It followed on from a review in 2014 based on which the European Medicines Agency took the decision to...

Leaders' Questions (9 Nov 2017)

Louise O'Reilly: I thank the Tánaiste for her response. The families affected believe they have been ignored, sidelined and let down by the State. I am giving the Tánaiste an opportunity to make a statement on behalf of the Government to the effect that it will consider the issues of compensation, establishing a register for those who have taken or will take valproate and the putting in place of...

Written Answers — Department of Health: Medicinal Products Data (9 Nov 2017)

Louise O'Reilly: 144. To ask the Minister for Health if a registry of the children affected by foetal anticonvulsant syndrome, also known as foetal valproate syndrome, during pregnancy will be established; and if he will make a statement on the matter. [47360/17]

Written Answers — Department of Health: Medicinal Products Data (9 Nov 2017)

Louise O'Reilly: 145. To ask the Minister for Health if a registry of the women affected by taking sodium valproate during pregnancy will be established; and if he will make a statement on the matter. [47361/17]

Written Answers — Department of Health: Medicinal Products Data (9 Nov 2017)

Louise O'Reilly: 146. To ask the Minister for Health if additional services for children affected by foetal anticonvulsant syndrome during pregnancy will be provided; and if he will make a statement on the matter. [47362/17]

Written Answers — Department of Health: Medicinal Products Data (9 Nov 2017)

Louise O'Reilly: 147. To ask the Minister for Health if a six-monthly screening process for a person exposed to sodium valproate during pregnancy will be provided in order that problems are recognised immediately and supports put in place; and if he will make a statement on the matter. [47363/17]

Written Answers — Department of Health: Medicinal Products Regulation (9 Nov 2017)

Louise O'Reilly: 148. To ask the Minister for Health the views of the HSE and his Department when their attention was drawn to the fact that pregnant women were being prescribed sodium valproate without proper provision of information on the side effects; and if he will make a statement on the matter. [47364/17]

Joint Oireachtas Committee on the Eighth Amendment of the Constitution: Business of Joint Committee (8 Nov 2017)

Louise O'Reilly: Agreed.

Joint Oireachtas Committee on the Eighth Amendment of the Constitution: International Legal and Services Context: Dr. Gilda Sedgh, Guttmacher Institute and Ms Leah Hoctor, Center for Reproductive Rights (8 Nov 2017)

Louise O'Reilly: I will not need the full six minutes as my question is a very simple one. It concerns the word "risk". We know from the Citizens' Assembly what it is that we are asked to consider here. The assembly has a gradation of risk or "serious risk" to use its own term. There are various definitions of what does or does not constitute risk. In Dr. Sedgh's experience, is it possible or even...

Joint Oireachtas Committee on the Eighth Amendment of the Constitution: International Legal and Services Context: Dr. Gilda Sedgh, Guttmacher Institute and Ms Leah Hoctor, Center for Reproductive Rights (8 Nov 2017)

Louise O'Reilly: Yes. My apologies. I should have been clearer.

Joint Oireachtas Committee on the Eighth Amendment of the Constitution: Risks to Mental Health: Dr. Anthony McCarthy, National Maternity Hospital, Holles Street (8 Nov 2017)

Louise O'Reilly: That is fine. To return to one of the points made by Senator Ruane, I do think there has to be a certain amount of respect given to those of us on the committee when we are discussing pregnancy related issues who have had that very personal experience. I found the content of some of what was said quite disrespectful. I do not intend to get into a row with anybody about it. In fact, the...

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)

Louise O'Reilly: I thank the witnesses for their evidence. I have a number of questions and I would imagine that none will shock or surprise the witnesses. Following our engagement with Alpha One Foundation, specifically in respect of Respreeza, I have stated publicly that the families of the patients involved have been treated disgracefully. I would apportion blame equally to all involved in this. The...

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)

Louise O'Reilly: To follow on from a point made by Deputy Kelleher, the rare diseases plan runs from 2014 to 2018 so we are very far into it. It strikes me that very little has been done. Will the witnesses give an indication as to whether they feel all of this work will be completed by the end of the plan? That is what people want to know. The witnesses might give us an idea of what will not be achieved...

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)

Louise O'Reilly: All members have done some research on the issue. Is it correct that there are young children on the drug in the countries the witness listed where conditional access has been granted?

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)

Louise O'Reilly: Let us take Britain as an example. In England and Northern Ireland the drug is being reimbursed. Is that being done on a conditional basis or otherwise?

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)

Louise O'Reilly: The families of the kids who are waiting to hear about the availability of this drug are very anxious and are watching these proceedings. They do not believe a mistake was made but, rather, a certain amount of compassion was shown. With regard to most of the countries where it is available or the countries the witness listed where it is not available in any form, conditional or otherwise,...

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)

Louise O'Reilly: I suspect Professor Barry is playing with words because I think it is available to people via the public system but we can agree to differ on that.

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)

Louise O'Reilly: As regards the Irish system, the witness knows the families are very anxious to know what will happen. There is a court case in progress and perhaps the witness will address that at a later stage.

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)

Louise O'Reilly: I have something that specifically relates-----

Joint Oireachtas Committee on Health: Evaluating Orphan Drugs: Discussion (Resumed) (8 Nov 2017)

Louise O'Reilly: I understand that. This relates to a question I asked.

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