Written answers

Tuesday, 29 July 2025

Department of Health

Medicinal Products

Photo of Ciarán AhernCiarán Ahern (Dublin South West, Labour)
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2678. To ask the Minister for Health if she is aware of the growing use of HHC (hexahydrocannabinol) vapes, a synthetic cannabinoid product, among young people; if the new Public Health (Nicotine Inhaling Products) Bill 2025 will contain provisions to curtail this trend; and if not, if she will produce separate legislation on the matter; and if she will make a statement on the matter. [41325/25]

Photo of Jennifer Carroll MacNeillJennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Public Health (Nicotine Inhaling Products) Bill will seek to further regulate nicotine inhaling products to reduce their use among young people, through restrictions on flavours, appearance and packaging, point of sale display and advertising, and a prohibition on single use vapes. The Bill will not regulate the synthetic cannabinoid Hexahydrocannabinol (HHC).

In the coming weeks the Government will be adding HHC to the Misuse of Drugs Regulations as a Schedule 1 controlled drug, the strictest level of control under which possession for personal use or sale and supply are offences under the Misuse of Drugs Act 1977.

I am fully satisfied that subjecting HHC to control measures is in the best interest of preserving public health.

Photo of Pádraig RicePádraig Rice (Cork South-Central, Social Democrats)
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2679. To ask the Minister for Health if the Medicines Management Programme’s proposed reclassification of high protein (HP) oral nutrition supplements to list B will be suspended to allow the scientific data to be properly evaluated; if she is aware of the joint position statement detailing the clinical, ethical, and economic concerns associated with this proposal endorsed by over 500 healthcare professionals and academic experts in clinical nutrition (details supplied); her views on this joint position statement; and if she will make a statement on the matter. [41357/25]

Photo of Pádraig RicePádraig Rice (Cork South-Central, Social Democrats)
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2680. To ask the Minister for Health if she will request that the Medicines Management Programme begins formal engagement with the Irish Society for Clinical Nutrition and Metabolism, the Irish Nutrition and Dietetic Institute and academic nutrition leaders to revise guidance on high-protein (HP) ONS products in line with international expert consensus; and if she will make a statement on the matter. [41358/25]

Photo of Jennifer Carroll MacNeillJennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 2679 and 2680 together.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, I have asked the HSE for an update in this matter.

Foods for Special Medical Purposes (FSMP) including Clinical Nutritional Products are added to the Reimbursement List following a pricing and reimbursement application from nutritional companies in line with the Health (Pricing and Supply of Medical Goods) Act 2013. In 2023, total expenditure by the PCRS on Clinical Nutritional Products on the General Medical Services (GMS), Drugs Payment Scheme (DPS) and Long Term Illness (LTI) Scheme was €48.28 million, €7.68 million and €8.56 million respectively.

Analysis shows there has been an increase in utilisation of, and total expenditure on, high-protein Oral Nutritional Supplements (ONS) under the various Community Drug Schemes over the last five years. The total monthly expenditure increased from approximately €0.49 million in July 2019 to approximately €1.39 million in December 2023. The number of patients in receipt of high-protein ONS on a monthly basis increased from approximately 6,200 to approximately 16,500 over the same time period.

The PCRS Annual Reports are published online at: www.sspcrs.ie/portal/annual-reporting/report/annual.

Given the high expenditure growth in this area, the HSE-Medicines Management Programme (MMP) undertook a review of high-protein ONS with a view to identifying preferred product(s) as part of the MMP's remit to support safe, effective and cost-effective prescribing in the Irish healthcare setting. The evaluation report is publicly available online at: www.hse.ie/eng/about/who/cspd/medicines-management/oral-nutritional-supplements/preferred-high-protein-ons-evaluation.pdf.

Following review of the submissions received in accordance with the criteria outlined in the roadmap (www.hse.ie/eng/about/who/cspd/medicines-management/oral-nutritional-supplements/mmp-roadmap-for-the-identification-of-preferred-high-protein-oral-nutritional-supplement-s-.pdf), the MMP is currently unable to identify preferred high-protein ONS.

The MMP recommends that high-protein ONS be added to List B (non-preferred ONS). The scope of the reimbursement application system in place for non first-line standard ONS should be broadened to include high-protein ONS, which will require prior approval for reimbursement under Community Drug Schemes.

The HSE is carefully considering the recommendations of the MMP under Section 20 of the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE PCRS have written to the relevant nutritional companies regarding the proposal and have provided them with the right to make representations. The period for representations has now closed and written submissions are under consideration. The HSE will carefully consider any representations made.

At present, a decision has not been made by the HSE under Section 20* of the 2013 Act.

* Conditional Supply of Listed Items

20. — (1) The Executive may attach conditions to the supply or reimbursement, under section 59 of the Act of 1970, of listed items (including classes of listed items) in the interests of one or more of the following:

(a) patient safety;

(b) cost-effectiveness;

(c) maximising appropriate use of the listed items concerned;

(d) appropriately applying the resources available to the Executive.

(2) Without prejudice to the generality of the Executive’s power under subsection (1) to attach conditions to the supply or reimbursement, under section 59 of the Act of 1970, of listed items (including classes of listed items), such conditions may include one or more of the following:

(a) protocols for the supply of the listed items;

(b) the quantity of listed items which may be supplied or reimbursed, or both, during a specified period, in respect of a patient or a class of patients, or both, or in respect of patients in general;

(c) the period during which listed items may be supplied or reimbursed, or both;

(d) restrictions on the purposes for which listed items may be supplied;

(e) restrictions on the classes of prescribers who may prescribe the listed items;

(f) restrictions on the classes of patients who may be supplied with, or reimbursed under that section for, the listed items.

(3) The Executive shall, as soon as is practicable after the commencement of this section, establish and keep under review procedures designed to ensure that listed items are supplied or reimbursed, under section 59 of the Act of 1970, only if the conditions (if any) attached under this section to such supply or reimbursement, as the case may be, are complied with.

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