Written Answers Nos. 121-141
121. Deputy Paul Donnelly asked the Minister for Health the locations of HSE-funded dementia day care centres within CHO9; the capacity of each of these day care centres; and the days of the week each of those day care centres are opened, in tabular form. [26321/24]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
122. Deputy Paul Donnelly asked the Minister for Health if a consultant ophthalmologist and or ophthalmologist registrar is on call at the Mater Hospital on a 24-7 basis. [26322/24]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
123. Deputy Paul Donnelly asked the Minister for Health for an update on perinatal services currently in the CHO7 area. [26323/24]
View answerAs this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
124. Deputy Leo Varadkar asked the Minister for Health to provide assurance that the general scheme for a statutory home care scheme will be published in 2024; the reason progress has been slow in the past two years; and to set out in detail the extent and depth of civil service resources being allocated to the project, that is, the number of staff and grade; and if this is the main work. [26341/24]
View answerThe Programme of Government commitment to “introduce a statutory scheme to support people to live in their own homes, which will provide equitable access to high quality, regulated home care” requires focused effort across several different workstreams that are all contributing towards strengthening the statutory framework and improving the experiences of those receiving home support.
The first element that is being legislated for relates to the licensing and registration of home support providers. The General Scheme to establish a licensing framework for professional home support services delivered in the State - the Health (Amendment) (Licensing of Professional Home Support Providers) Bill 2024 General Scheme - was approved by Government on 14 May 2024 and is published on the Department of Health’s website. It has been referred to the Joint Oireachtas Committee on Health for pre-legislative scrutiny and Department officials are due to meet with the Committee on 19 June 2024.
This Bill will provide for the regulation of the sector by HIQA. Final amendments have been made to draft regulations for home support providers following a public consultation and engagement with stakeholder groups. The Department has been working closely with HIQA, which has prepared draft quality standards that are expected to go out for public consultation Q3 2024.
As well as delivering on the legislative elements of this commitment, the Department is working to address the future financing of homecare, the reform of the model of service delivery and the breadth of issues relating to recruitment and retention in this sector; all in the context of unprecedented expansion of the State-funded home support service, nationally.
Over the last two years, extensive work has taken place within the Department of Health to progress the Programme of Government commitment, including but not limited to:
• Development of draft regulations, which were informed by a 6-week public consultation completed in August 2022. The consultation results were analysed and published, and have been incorporated in revisions to the draft regulations.
• Oversight of the pilot for testing of a reformed model of service for the delivery for homecare, which became fully operational in 4 Community Healthcare Organisations in this period. Evaluation of the pilot has been completed and reviewed.
• Ongoing engagement with the HSE on the continuing reform of the model of service delivery for home support. Funding has been provided for establishment of a National Home Support Office and the Head of Service, and a number of other posts have been recruited. The national rollout of interRAI as the new standard assessment tool for care-needs in the community is underway.
• Addressing the shortage of care workers in Ireland through establishing, in March 2022, a cross departmental Strategic Workforce Advisory Group. After extensive engagement and consultation, in September 2022, the group published a report containing 16 recommendations to address workforce challenges. Implementation is being overseen by a cross-departmental Implementation Group, chaired by the Department of Health.
• Extensive engagement with the HSE and DPENDR on the establishment of the HSE home support tender in 2023, ensuring that it delivers on commitments for sectoral reform such as payment for travel time for home support providers, paying carers the National Living Wage at a minimum, and bringing legacy rates in line with the new revised rates of funding.
• Liaising with the DETE on bringing forward a statutory instrument authorising the issuance of 1,000 employment permits for home support workers.
• Commissioning multiple reports on potential demand, costs and charging models for home support, from the ESRI and the European Observatory on Health Systems. This research is being examined, as it forms an important part of the evidence base for the development of a sustainable funding model for home support services in the context of our ageing population.
• Expanding access to home support services through securing significant increases in funding through annual Estimates processes.
Regarding the civil service resources allocated to this area there are 8 staff members for whom this is their primary work: 1 Principal Officer, 3 x Assistant Principal or analogous; 2 x Higher Executive Officer / Administrative Officer; and 2 x Executive Officer.
125. Deputy Cian O'Callaghan asked the Minister for Health if the supply of a medication (details supplied) can be prioritised; and if he will make a statement on the matter. [26346/24]
View answerNovo Nordisk, the company responsible for supplying Ozempic, has advised of supply issues with its glucagon-like peptide-1 (GLP-1) receptor agonist products including Ozempic. Novo Nordisk has outlined that these supply issues are due to increased global demand for GLP-1 products coupled with manufacturing capacity constraints at manufacturing sites. The company anticipates that intermittent supply issues will continue in 2024.
Novo Nordisk has notified shortages of the following Ozempic products:
• Ozempic 0.25mg solution for Injection in pre-filled pen: Novo Nordisk has notified a current shortage of this product due to a manufacturing delay. The shortage began in early June 2024 and the company has informed the Health Products Regulatory Authority (HPRA) that resupply is expected mid-July 2024.
• Ozempic 0.5mg solution for Injection in pre-filled pen: Novo Nordisk has notified a shortage of this product due to a manufacturing delay. The shortage began in early June 2024 and the company informed the HPRA that resupply is expected on 18th June 2024. It is understood that it may take 24-48 hours for stock to be available to order at pharmacy level once resupply occurs.
Monthly allocations have been implemented at wholesale level to help ensure continuity of supply and equitable distribution of stock to patients. Pharmacies are advised to not order extra quantities of Ozempic over and above immediate patient need as doing so could exacerbate the supply constraints.
To assist in the management of this product shortage, prescribing and dispensing should be prioritised for the licensed indication and restricted to a one-month supply.
Healthcare professionals are requested to ensure that patients prescribed Ozempic are made aware of this issue and to consider the most suitable course of action for the individual including whether a patient can be safely prescribed a clinically appropriate alternative, if required.
The Health Products Regulatory Authority (HPRA) is engaging closely with the company and the wholesalers involved in the supply of this product to keep the health system and the public informed - www.hpra.ie/docs/default-source/Shortages-Docs/ozempic-availability-september---info-for-hcps-and-patients---1-sept-2023701f152697826eee9b55ff00008c97d0.pdf?sfvrsn=2
Novo Nordisk has issued letters to relevant stakeholders, including healthcare professionals to ensure they are aware of this supply issue and its management.
Further information and HSE guidance is also available relating to Ozempic supply interruption for healthcare professionals and patients - www.hpra.ie/docs/default-source/Shortages-Docs/glp1-ra-shortage-clinical-advice-ncpd-01112023.pdf?sfvrsn=2
I recognise that medicine shortages can be challenging for patients, carers, healthcare professionals and their teams. Based on shortages notified to the HPRA, this matter has been the subject of engagement across Health Service stakeholders. Where at all possible, all parties are focused on pre-empting and responding to any potential impacts on medicines supply. Where a shortage cannot be prevented, we will aim to provide useful information to healthcare professionals and patients.
The HPRA maintains a list of current and resolved shortages on www.hpra.ie/homepage/medicines/medicines-information/medicines-shortages, where the details, including the information above, are detailed. The webpage is updated daily as new information is received.
Patients who have any concerns about availability of their medication are encouraged to speak to their GP or pharmacist.
126. Deputy Jim O'Callaghan asked the Minister for Health if he intends to take steps to inform the public of the dangers associated with buying tobacco through unauthorised retail outlets; and if he will make a statement on the matter. [26349/24]
View answerCombustible tobacco is a lethal product, regardless of the source, and it kills two out three of long-term users when used as intended by the manufacturer. The HSE is responsible for public campaigns communicating the harms of tobacco use and promoting smoking cessation under the Quit Campaign. There are currently no plans to amend this messaging.
Currently retailers must register with the HSE to sell tobacco products. The Public Health (Tobacco Products and Nicotine Inhaling Products) Act 2023 provides for the introduction of a new licensing system for the retail sale of tobacco products and nicotine inhaling products. Under the Act, an annual licence will be required for each outlet where tobacco products or nicotine inhaling products are sold.
Monitoring and combatting illicit trade of tobacco is a matter for the Department of Finance and the Revenue Commissioner.
127. Deputy Eoin Ó Broin asked the Minister for Health the national laws and regulations that give effect to the clinical trial of an investigational medicinal product reporting requirements set out in the EU Clinical Trial Regulation, article 37(4) specifying the name and applicable article(s) of all relevant laws and regulations. [26361/24]
View answer128. Deputy Eoin Ó Broin asked the Minister for Health the national laws and regulations that define the penalties for infringements of the EU Clinical Trial Regulation, as set out in article 94 specifying the name and applicable article(s) of all relevant laws and regulations. [26362/24]
View answer129. Deputy Eoin Ó Broin asked the Minister for Health to provide the penalties that he will be able impose for infringements of clinical trial of an investigational medicinal product reporting requirements specifying the penalties, for example the maximum fine(s) that can be imposed. [26363/24]
View answerI propose to take Questions Nos. 127, 128 and 129 together.
The Clinical Trial Regulation (Regulation 536/2014) (CTR) repealed the Clinical Trial Directive (2001/20/EC) (CTD) on 31 January 2022, subject to a transition period for clinical trials started under the CTD prior to this date. This transition period will come to an end on 31 January 2025 and any ongoing trials approved under the CTD must be compliant with the CTR.
The CTR was transposed into Irish law via European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) Regulations 2022 – S.I. No. 99 of 2022. This SI was subsequently amended by the European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) (Amendment) Regulations 2022 (S.I. No. 418 of 2022) and the European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) (Amendment) Regulations 2022 (S.I. No. 727 of 2022), the latter of which was repealed by the European Union (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2024 (S.I. No. 3 of 2024).
SI 99 of 2022 sets out penalties which could be imposed if a person is guilty of an offence under those Regulations. Part 12 deals with Offences, Penalties and Enforcement, with Regulation 49 covering penalties specifically.
As stated in Regulation 49:
(1) A person guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding €3,000, or to imprisonment for a term not exceeding six months, or both. (2) A person guilty of an offence under these Regulations shall be liable on conviction on indictment to a fine not exceeding €300,000, or to imprisonment for a term not exceeding 3 years, or both.
Regulation 48 details Offences under the Regulations, including failure to meet reporting requirement, such as those set out in Article 37(4). These reporting requirements are covered in Regulation 48(1)(r) and (aa).
130. Deputy Eoin Ó Broin asked the Minister for Health to provide the legal and regulatory requirements to make the results of interventional clinical trials that are not a clinical trial of an investigational medicinal product (including medical device trials and non-drug trials) public and to provide the exact name and applicable article(s) of all relevant laws and regulations. [26364/24]
View answerThe exact nature of the question being asked is a little unclear, however in framing a general response on the publication of information pertaining to clinical trials, it should be noted that there are relevant obligations in place with respect to clinical trials authorised under the Clinical Trials Directive (CTD). It should also be noted that all trials authorised under the CTD must end or transition to the Clinical Trials Regulation (536/2014) by 31st January 2025. The Clinical Trials Regulation (CTR) came into effect in the EU on 31 January 2022.
131. Deputy Brendan Griffin asked the Minister for Health if a person in County Kerry (details supplied) will be approved for a pair of replacement glasses; and if he will make a statement on the matter. [26372/24]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
132. Deputy Johnny Guirke asked the Minister for Health the number of people in County Meath who are currently waiting on the physical provision of homecare hours, by waiting times, by month, in tabular form; and if he will make a statement on the matter. [26377/24]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible
133. Deputy Jim O'Callaghan asked the Minister for Health further to Parliamentary Question No. 169 of 29 May 2024, the reason the eye exam is not paid by the local areas of CHO7, 8 (Meath only) and 9; if there are proposals to change this in order that they are paid; and if he will make a statement on the matter. [26389/24]
View answerAll children, including those not covered by a medical card, receive a vision screen while in national school from a Public Health Nurse. The Health Service Executive (HSE) provides optical services free of charge to pre-school children and national school children referred from child health service and school health service examinations who are discovered to have sight problems. These children are referred to the appropriate consultant for treatment. In such circumstances, these services will continue to be provided until the child has reached the age of 16.
The HSE Primary Care Eye Services Review Group Report, published in June 2017, highlighted the limitations of the current model of service delivery and set out the way forward for a significant amount of eye services to be delivered in a primary care setting. The Report estimated that 60% of existing outpatient activity could be moved to primary care thus enabling hospital services to focus on patients who require more specialist diagnostics or treatments.
The National Clinical Programme for Ophthalmology developed a model of care, also published in 2017, detailing how the realignment of eye services from the acute hospitals to the community will be undertaken. Included in current priorities is transferring the care of children aged 8+ years to the care of local private optometrists. While a national scheme has not yet been implemented, some Community Healthcare Organisations have discharged some children aged 8+ into the care of local optometrists.
I have asked the HSE to prepare a detailed costed implementation plan regarding the transfer of care for children aged 8+ to local optometrists to be undertaken on a national basis. This would include the provision of paediatric eye exam. The implementation of such a national scheme remains a priority. Of course, any publicly funded ophthalmic service expansion should address unmet public healthcare needs and improve access to public health services while ensuring value for money.
134. Deputy Aengus Ó Snodaigh asked the Minister for Health the reason a seven-year-old child (details supplied) does not reach the criteria for CAMHS intervention in Cherry Orchard. [26393/24]
View answerAs this is a service matter, I have asked the Health Service Executive to respond Directly to the Deputy as soon as possible.
135. Deputy Aengus Ó Snodaigh asked the Minister for Health the assistance that can be given to a child (details supplied) who is experiencing bouts of self-harm and assaulting their SNA and family members. [26394/24]
View answerAs this is a service matter, I have asked the Health Service Executive to respond Directly to the Deputy as soon as possible.
136. Deputy Aengus Ó Snodaigh asked the Minister for Health the reason the private assessment carried out for a child (details supplied) is not recognised by the HSE. [26395/24]
View answerAs this is a service matter, I have asked the Health Service Executive to respond Directly to the Deputy as soon as possible.
137. Deputy Patrick Costello asked the Minister for Health further to Parliamentary Question No. 717 of 11 June 2024, the particular paragraph of the mentioned 388-page report that outlines the risk as indicated by the National Gender Service. [26401/24]
View answer“As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.”
138. Deputy Patrick Costello asked the Minister for Health further to Parliamentary Question No. 717 of 11 June 2024, the level of decline in mental, social, and/or occupational function that has been found in the patient audits of the National Gender Service. [26402/24]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
139. Deputy Patrick Costello asked the Minister for Health the number of category-one adverse events that have been recorded by the National Gender Service, broken down by year, in tabular form. [26403/24]
View answer“As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.”
140. Deputy Patrick Costello asked the Minister for Health the practices of the National Gender Service that a conversion therapy ban "could have negative implications on", as stated in its October 2023 clinical governance committee minutes. [26404/24]
View answer“As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.”
141. Deputy Patricia Ryan asked the Minister for Health the current number of people under 18 are currently waiting on audiometry tests in CHO7. [26405/24]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
