Results 18,721-18,740 of 49,836 for speaker:Stephen Donnelly

Written Answers — Department of Health: Covid-19 Pandemic (13 Jul 2022)

Stephen Donnelly: Firstly I would like to extend my sincere gratitude to all healthcare workers for their efforts during this most challenging period. As the deputy is aware, on January 19th, the Government announced a COVID-19 pandemic recognition payment for frontline public sector healthcare workers, to recognise their unique role during the pandemic. Following extensive engagement with healthcare unions on...

Written Answers — Department of Health: Covid-19 Pandemic (13 Jul 2022)

Stephen Donnelly: Firstly I would like to extend my sincere gratitude to all healthcare workers for their efforts during this most challenging period. On January 19th, the Government announced a COVID-19 pandemic recognition payment for frontline public sector healthcare workers, to recognise their unique role during the pandemic. Following extensive engagement with healthcare unions on the matter, on 19th...

Written Answers — Department of Health: Covid-19 Pandemic (13 Jul 2022)

Stephen Donnelly: I propose to take Questions Nos. 477, 558 and 559 together. Firstly I would like to extend my sincere gratitude to all healthcare workers for their efforts during this most challenging period. On January 19th, the Government announced a COVID-19 pandemic recognition payment for frontline public sector healthcare workers, to recognise their unique role during the pandemic. Following extensive...

Written Answers — Department of Health: Covid-19 Pandemic (13 Jul 2022)

Stephen Donnelly: I propose to take Questions Nos. 478, 544, 545 and 546 together. As this is a service matter, I have asked the Health Service Executive to reply to the Deputy directly.

Written Answers — Department of Health: Covid-19 Pandemic (13 Jul 2022)

Stephen Donnelly: As this is a service matter, I have asked the Health Service Executive to reply to the Deputy directly.

Written Answers — Department of Health: Medicinal Products (13 Jul 2022)

Stephen Donnelly: I propose to take Questions Nos. 480 and 481 together. Following a tender by the Office of Government Procurement, Mazars conducted a review of the governance structures around the HSE's drug reimbursement process. The report was submitted to my Department in January 2020. The review made recommendations in respect of the HSE’s systems, structures, processes, governance arrangements...

Written Answers — Department of Health: Health Strategies (13 Jul 2022)

Stephen Donnelly: I propose to take Questions Nos. 482, 483, 484, 485, 497 and 499 together. A disease or disorder is defined as rare in Europe when it affects less than 1 in 2,000 people. There are approximately 8,000 known rare diseases; 80% of rare diseases are of genetic origin and are often chronic and life-threatening. Up to 1 person in 12 in Ireland may have a rare disease at some stage in their life....

Written Answers — Department of Health: Legislative Measures (13 Jul 2022)

Stephen Donnelly: In response to the Bill, the Department of Health, HSE and National Centre for Pharmacoeconomics had significant, detailed engagement on the current processes. It was concluded that the current Act does not present legal barriers for the approval of orphan drugs for reimbursement. The 2013 Health Act does not include provision for a different ruleset when assessing orphan medicines....

Written Answers — Department of Health: Medicinal Products (13 Jul 2022)

Stephen Donnelly: I propose to take Questions Nos. 487, 490, 492 and 495 together. The 2013 Health (Pricing and Supply of Medical Goods) Act is a clear, robust, statutory framework under which all new medicinal products must be assessed by the HSE. The HSE is the statutory decision-maker for the reimbursement of such products, and the Act ensures that these decisions are made on an objective and scientific...

Written Answers — Department of Health: Medicinal Products (13 Jul 2022)

Stephen Donnelly: The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licenced indications which have been granted market authorisation either by the European Medicines Agency (EMA) or by the Health Products Regulatory Authority. The...

Written Answers — Department of Health: Medicinal Products (13 Jul 2022)

Stephen Donnelly: Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Written Answers — Department of Health: Medicinal Products (13 Jul 2022)

Stephen Donnelly: The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics...

Written Answers — Department of Health: Medicinal Products (13 Jul 2022)

Stephen Donnelly: I can confirm that interim and early access reimbursement models have been examined. The HSE and the Department would not support a pathway enabling reimbursement in the Irish context while further clinical evidence and data is collected on a given medicine. The HSE and NCPE advise that such a pathway would rest on the assumption that the collected data would support a positive...

Written Answers — Department of Health: Medicinal Products (13 Jul 2022)

Stephen Donnelly: Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes. The 2013 Health (Pricing and Supply of Medical Goods) Act is a clear, robust, statutory framework under which all new medicinal products must be assessed by the HSE. The HSE is the statutory decision-maker for the reimbursement of such...

Written Answers — Department of Health: Medicinal Products (13 Jul 2022)

Stephen Donnelly: Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Written Answers — Department of Health: Intellectual Property (13 Jul 2022)

Stephen Donnelly: While the pricing of medicines is not considered to be fully unrelated to intellectual property rights, particularly in the context of monopoly suppliers, pricing determination remains a national competency. The European Commission has developed an intellectual property rights framework to encourage and sustain innovation by the pharmaceutical industry in developing new medicinal products....

Written Answers — Department of Health: Medicinal Products (13 Jul 2022)

Stephen Donnelly: The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for reply to the Deputy.

Written Answers — Department of Health: Medicinal Products (13 Jul 2022)

Stephen Donnelly: My Department has significant engagement at EU level, which is supported and serviced by the Permanent Representation of Ireland to the European Union in Brussels. The resourcing of this work is kept under review to ensure Ireland’s health interests are adequately promoted and represented within the EU and its institutions. Accordingly, with the agreement of the Department of Foreign...

Written Answers — Department of Health: Medical Aids and Appliances (13 Jul 2022)

Stephen Donnelly: The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or...

Written Answers — Department of Health: Departmental Staff (13 Jul 2022)

Stephen Donnelly: The Secretary General of my Department has a current annual salary of €297,869 since 1 February 2022. The requested salary information paid to Ministers and/or Ministers of State in my Department is available on the Department of Public Expenditure and Reform (DPER) website at the following link: assets.gov.ie/216182/3ab494d7-88f3-4138-83f3-4d307f81c6e8.pd f. Circular 04 of 2022 sets...