Tuesday, 8 Jul 2025

Written Answers Nos. 858-872

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Health Services

Questions (858)

Martin Daly

Question:

858. Deputy Martin Daly asked the Minister for Health if she will address the lack of access to manual lymphatic drainage (MLD) therapy for lymphedema patients across County Roscommon, where no physiotherapists within the HSE service are currently trained to provide this essential treatment; if funding constraints are the cause of this service gap; and if she will ensure that all patients in Roscommon have equitable access to MLD, including the possibility of accessing services in nearby centres such as Sligo, Leitrim, Offaly, Westmeath & Galway regardless of county boundaries. [37720/25]

Written answers

Minister for Health

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Misuse of Drugs

Questions (859)

Martin Daly

Question:

859. Deputy Martin Daly asked the Minister for Health if the semi-synthetic cannabinoid hexahydrocannabinol (HHC), commonly found in vape products, will be included under schedule 1 of the Misuse of Drugs Regulations, and if so, when the amendment is expected to take effect. [37721/25]

Written answers

Minister for Health

It is the intention of the Government to subject Hexahydrocannabinol (HHC) to control measures under the Misuse of Drugs legislation as a Schedule 1 controlled drug. This is the strictest level of control where possession and/or sale or supply of the substance is an offence under the Misuse of Drugs Act 2017. It is expected that this legislation will be brought to Government very shortly.

Food Safety

Questions (860)

Peter 'Chap' Cleere

Question:

860. Deputy Peter 'Chap' Cleere asked the Minister for Health if she is concerned by the absence of public guidance from the FSAI regarding the impact of UK folic acid flour fortification from October 2025, despite this change being just three months away; and whether she will instruct the authority to immediately engage with industry to mitigate packaging and labelling compliance risks considering Northern Irish food producers have such mitigation measures provided for identical packaging and labelling regulation? [37722/25]

Written answers

Minister for Health

The FSAI is the central competent authority for the enforcement of food safety legislation in Ireland.

The FSAI has fully engaged with the Department of Health on the matter of the UK changes to fortification of flour and will be publishing a document to provide information to the public in relation to the upcoming changes.

This matter has arisen due to changes in UK legislation which UK industry has decided to implement ahead of the UK legislative date of application. As an EU Member State Ireland is obliged to implement EU law regarding labelling of fortified food to ensure consumers are not mislead regarding fortification of food.

The FSAI has engaged with the food industry for many months on this matter including through a number of food industry fora, in addition to responding directly to queries which are submitted through their advice line to provide clarity on the application of EU law on this matter. My Department along with the FSAI has also engaged with UK flour millers. The FSAI will continue to engage with industry through these channels on this matter.

Food Safety

Questions (861, 862)

Peter 'Chap' Cleere

Question:

861. Deputy Peter 'Chap' Cleere asked the Minister for Health if she will urgently engage with food manufacturers, bakeries, and retailers to assess the impact of folic acid-fortified UK flour entering the Irish market from October 2025; and whether she will consider emergency support measures, given the extremely limited time now available for labelling compliance and packaging changes under EU Regulation 1169/2011 given that food manufacturers, bakeries, and retailers in Northern Ireland have some provisions from the competent authority for food labelling in Northern Ireland ? [37723/25]

Peter 'Chap' Cleere

Question:

862. Deputy Peter 'Chap' Cleere asked the Minister for Health if she has raised, or will raise urgently, the issue of mandatory folic acid fortification of UK flour with the European Commission or relevant EU working groups, with a view to coordinated guidance or flexibilities for member states reliant on UK flour imports. [37724/25]

Written answers

Minister for Health

I propose to take Questions Nos. 861 and 862 together.

I am aware of the recent legislative changes in the United Kingdom (UK) concerning the fortification of non-wholemeal flour with folic acid (FA). I am also informed that this may have a considerable impact on food businesses in Ireland due to the significant amount of flour and compound goods containing flour imported from the UK.

Officials from my Department have engaged with officials from the Department of Agriculture, Food and the Marine and the Department of Enterprise, Tourism and Employment and Industry Representative bodies on this matter. These meetings have highlighted the impact that these changes will have on food business operators.

Regulation (EU) 1169/2011 on the provision of food information for consumers, provides assurance that consumers are not mislead and ensures that public health is protected by requiring accurate and clear labelling on food.

My Department has contacted the EU Commission and requested a meeting with the responsible Unit to discuss the topic with a view to agreeing a pragmatic interim solution. A letter outlining the situation has also been sent to the Commission.

Introducing emergency support measures for businesses is not within the remit of the Department of Health and would be a matter for either the Department of Agriculture, Food and the Marine or the Department of Enterprise, Tourism and Employment.

Question No. 862 answered with Question No. 861.

Departmental Correspondence

Questions (863)

Sean Fleming

Question:

863. Deputy Seán Fleming asked the Minister for Health to reply to attached correspondence (details supplied); and if she will make a statement on the matter. [37728/25]

Written answers

Minister for Health

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Hospital Facilities

Questions (864)

Claire Kerrane

Question:

864. Deputy Claire Kerrane asked the Minister for Health if, following a query (details supplied), a wider issue will also be rectified; and if she will make a statement on the matter. [37732/25]

Written answers

Minister for Health

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

International Protection

Questions (865)

Ryan O'Meara

Question:

865. Deputy Ryan O'Meara asked the Minister for Health the mental health supports available to children and adults in IPAS accommodation; if specialist services for trauma and, more generally, services that can address the unique experience of undergoing the international protection process are provided; and if she will make a statement on the matter. [37734/25]

Written answers

Minister of State at the Department of Health (Deputy Colm Burke)

This PQ relates to the provision of services. It has been forwarded to the Health Service Executive to respond directly to the Deputy.

Medical Aids and Appliances

Questions (866)

David Cullinane

Question:

866. Deputy David Cullinane asked the Minister for Health the reason the mini-TT 380 copper coil is not included in the free contraceptive scheme; if this coil has not been included as a reimbursable items due to a clinical concern or due to the lack of an application from the supplier or for another reason; if so the reason; and if she will make a statement on the matter. [37758/25]

Written answers

Minister of State at the Department of Health (Deputy Colm Burke)

The free contraception scheme was launched in September 2022, initially for those aged 17-25. It has been gradually expanded and now includes women aged 17-35 from July 1st, 2024. The scheme is open to women, girls and other people identifying as transgender or non-binary, who are ordinarily resident in Ireland and for whom prescription contraception is deemed suitable by their doctors.

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Medicines and devices provided to GMS (medical) card holders and through the free contraception scheme are listed on the Reimbursement List, which can be accessed and searched at the following link:

www.hse.ie/eng/staff/pcrs/items/#:~:text=List%20of%20Reimbursable%20Items%20-%20provides%20a%20full,%28Medical%20Card%29%20or%20DPS%20%28Drugs%20Payment%20Scheme%29%20schemes.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 (NCPE). The Minister for Health has no role in these decisions. The HSE considers the NCPE assessment, the outputs from commercial engagements, patient interest group submissions, and any other pertinent information in advance of making a reimbursement decision.It is necessary for manufacturers of medicines and devices to complete the application process to have products included on the Reimbursement List which can be accessed and searched at www.sspcrs.ie/druglist/pub.

From Q1, 2025, the HSE advises that there is now one form of the copper coil, the Yanae, which is included on the Re-Imbursement List, and is therefore available through the Free Contraception Scheme - Yanae Cu 380 Mini Intrauterine Device Pack 1 (A), code 67255.

Health Service Executive

Questions (867)

Frankie Feighan

Question:

867. Deputy Frankie Feighan asked the Minister for Health the levels of expenditure that the HSE sanctions without sign-off from the HSE senior leadership team, with sign-off from the HSE senior leadership team, and following consultation with the Department of Public Expenditure, Infrastructure, Public Service Reform and Digitalisation; if these levels of expenditure are consistent across all areas of healthcare expenditure, or if there is specific governance for particular areas of expenditure (e.g. new medicines); and if she will make a statement on the matter. [37768/25]

Written answers

Minister for Health

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Clinical Trials

Questions (868, 869, 871, 872)

Frankie Feighan

Question:

868. Deputy Frankie Feighan asked the Minister for Health for an update on the implementation of the interim recommendations she received from the National Clinical Trials Oversight Group; and if she will make a statement on the matter. [37769/25]

Frankie Feighan

Question:

869. Deputy Frankie Feighan asked the Minister for Health for an update on the proportion of clinical trials initiated in Ireland since 2023 that have met the 42-days key performance indicator for regulatory approval, ethics approval and contracting, in tabular form; and if she will make a statement on the matter. [37770/25]

Frankie Feighan

Question:

871. Deputy Frankie Feighan asked the Minister for Health to report, on a hospital-by-hospital basis, on utilisation by public hospitals of clinical research organisation services, and on associated charging overheads, in tabular form; and if she will make a statement on the matter. [37772/25]

Frankie Feighan

Question:

872. Deputy Frankie Feighan asked the Minister for Health with reference to governance of clinical trials in which public hospitals participate, if national guidance has been issued for data impact assessments; if she will report, on a hospital-by-hospital basis, if hospitals are following national guidance, in tabular form; and if she will make a statement on the matter. [37773/25]

Written answers

Minister for Health

I propose to take Questions Nos. 868, 869, 871 and 872 together.

The National Clinical Trials Oversight Group (NCTOG) was established in July 2024 with the primary aim of increasing the number of clinical trials taking place in Ireland, particularly those involving investigational medicinal products.

The NCTOG's Interim Recommendations were published at the end of October 2024, and were noted by Government in November 2024. The interim recommendations identified three key areas (Contracts, Costings, and Data Protection), where streamlining and clarification of administrative processes would help alleviate several barriers faced by those parties wishing to conduct and participate in clinical trials in Ireland. The NCTOG and its members' respective organisations and partner organisations have been continuing to work towards implementing the recommendations wherever possible, and this work is ongoing (Outputs of the National Clinical Trials Oversight Group) www.gov.ie/en/department-of-health/collections/outputs-of-the-national-clinical-trials-oversight-group/.

On contracts, streamlined Clinical Trial Agreement templates have been developed for use across the healthcare system, which will help improve efficiency and time to start-up of clinical trials. In terms of data protection, my Department has recently published guidance which was developed in partnership with the NCTOG and the Data Protection Commission, which will guide organisations in terms of responsibilities for performing Data Protection Impact Assessments by providing a unified understanding on the interpretations of the regulations. Specific work on clinical trial costings has also been carried out through a sub-group of the NCTOG who have been developing recommendations in this area, which will be among the NCTOG's final recommendations that will be published later this year.

A central recommendation in the NCTOG's interim report was the creation of a dashboard platform to significantly improve transparency regarding performance and availability of trials across the clinical trials landscape. Progress is ongoing with initial phases of the dashboard's development focused on integrating key metrics and streamlining data flow from various stakeholders. As implementation is ongoing, specific data on these metrics are not yet available.

I look forward to updating my colleagues in Government in the coming weeks on the final recommendations of the NCTOG and moving forward with the all important implementation phase as we continue to transform the clinical trials landscape in Ireland for better patient outcomes.

Question No. 869 answered with Question No. 868.

Clinical Trials

Questions (870)

Frankie Feighan

Question:

870. Deputy Frankie Feighan asked the Minister for Health the number of dedicated WTE clinical research staff employed by the Health Service Executive; the plans for additional recruitment in 2025 and 2026 of dedicated clinical research staff; and if she will make a statement on the matter. [37771/25]

Written answers

Minister for Health

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Question No. 871 answered with Question No. 868.

Question No. 872 answered with Question No. 868.

• Written Answers Nos. 842-857
• Written Answers Nos. 873-898