Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2791. To ask the Minister for Health if she will consider reviewing the current regulatory status of melatonin in Ireland, given that it is available over the counter in many EU countries. [41999/25]

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2792. To ask the Minister for Health if she will outline the rationale for maintaining prescription-only of melatonin access in this jurisdiction. [42000/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 2791 and 2792 together.

Melatonin is a medicinal product (www.hpra.ie/find-a-medicine/for-human-use) most often used to treat insomnia characterised by poor quality of sleep. Melatonin is currently listed in Column A of the first schedule to the Prescription and Control of Supply Regulations S.I. No. 540/2003: www.irishstatutebook.ie/eli/2003/si/540/made/en/print This means it is a prescription only medicine that cannot be renewed. In Ireland, all currently authorised melatonin-containing medicinal products are subject to prescription control.

The Health Products Regulatory Agency (HPRA) are the entity responsible for the regulation of medicines in Ireland. It should be noted that the Health Products Regulatory Agency (HPRA) is open to review any application from a Marketing Authorisation Holder to change the prescription status of melatonin to non-prescription status. This is in line with the HPRA's policy to make medicines and health products available at the most convenient point of access for people, where it is safe and appropriate to do so following evaluation of all relevant data.

Once a marketing authorisation has been issued it is a matter for the marketing authorisation holder to decide whether to market the medicine in Ireland.

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2793. To ask the Minister for Health if she will address the significant cost disparity between Irish pharmacy-dispensed melatonin and equivalent products available legally from EU-based manufacturers. [42001/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA). In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

The HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.

The HSE robustly assesses applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.

There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.

The HSE considers the following criteria prior to making any decision on pricing / reimbursement in line with the Health (Pricing and Supply of Medical Goods) Act 2013:

(1) The health needs of the public,

(2) The cost effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,

(3) The availability and suitability of items for supply or reimbursement,

(4) The proposed costs, benefits, and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,

(5) The potential or actual budget impact of the item or listed item,

(6) The clinical need for the item or listed item,

(7) The appropriate level of clinical supervision required in relation to the item to ensure patient safety,

(8) The efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies), and

(9) The resources available to the HSE.

Regarding the specific details of melatonin:

Please be advised that there are several melatonin medicinal products licensed in Ireland and details can be found in the following link: www.hpra.ie/find-a-medicine/for-human-use

Melatonin (active substance) is currently listed in Column A of the first schedule to the Prescription and Control of Supply Regulations (S.I. No. 540/2003), i.e. prescription only medicine that cannot be renewed. In Ireland, all currently authorised melatonin-containing medicinal products are subject to prescription control.

However, it should be noted that the Health Products Regulatory Agency (HPRA) is open to review any application from a Marketing Authorisation Holder to change the prescription status of melatonin to non-prescription status. This is in line with the HPRA's policy to make medicines and health products available at the most convenient point of access for people, where it is safe and appropriate to do so following evaluation of all relevant data.

Once a marketing authorisation has been issued it is a matter for the marketing authorisation holder to decide whether to market the medicine in Ireland and the HPRA has no role in relation to the reimbursement of medicines.

Melatonin (Circadin®) underwent a review in 2008 and reimbursement was not recommended by the NCPE as there is currently insufficient evidence to support the reimbursement of this product under the Community Drugs Schemes (available at www.ncpe.ie/drugs/melatonin-circadin/).

The HSE Corporate Pharmaceutical Unit received an application for pricing and reimbursement of Melatonin (Slenyto® Prolonged-Release Tablets) in July 2019 from Flynn Pharma for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient. The first step in the process is the submission of a rapid review dossier (a clinical and economic dossier) to the National Centre for Phamacoeconomics (NCPE) for assessment. The rapid review was commissioned on 5th July 2022 and completed by the NCPE on 9th August 2022. The rapid review outcome recommends that a full Health Technology Assessment (HTA) is recommended to assess the clinical effectiveness and cost effectiveness of prolonged release melatonin (Slenyto®) compared to the current standard of care. However, to date the company have not made a HTA submission to the NCPE for assessment.

The position remains that a submission of a completed HTA dossier to the NCPE is required to progress this application, as per the formal processes governing the pricing and reimbursement of medicines.

The HSE Corporate Pharmaceutical Unit received an application for pricing and reimbursement of Melatonin (Voquily® 1mg/ml Oral solution) in September 2024 from Caragen Ltd for sleep onset insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been inadequate. The first step in the process is the submission of a rapid review dossier (a clinical and economic dossier) to the National Centre for Phamacoeconomics (NCPE) for assessment. However, to date the company have not made a Rapid Review submission to the NCPE for assessment.

The position remains that a submission of a completed Rapid Review dossier to the NCPE is required to progress this application, as per the formal processes governing the pricing and reimbursement of medicines.

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2794. To ask the Minister for Health 1792 the measures, if any, being considered to ensure price transparency, and to protect patients, particularly those with long-term conditions, from excessive mark-ups for essential medications that are not currently covered under public schemes such as the drug payment scheme or the medical card system. [42002/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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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 provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA). In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

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 actual budget impact. HSE decisions on which medicines are reimbursed are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

There has been a significant focus on improving access to and the affordability of healthcare services over the last few years. This includes reductions in the Drugs Payment Scheme threshold, expansion of access to free GP care, and the abolition of all public in-patient hospital charges for children and adults. These measures continue to create a health and social care service that offers affordable access to quality healthcare.

People who cannot, without undue hardship, arrange for the provision of medical services for themselves and their dependants may be eligible for a medical card under the General Medical Services (GMS) Scheme. In accordance with the provisions of the Health Act 1970 (as amended), eligibility for a medical card is determined by the HSE.

In certain circumstances the HSE may exercise discretion and grant a medical card, even though an applicant exceeds the income guidelines, where he or she faces difficult financial circumstances, such as extra costs arising from illness. In circumstances where an applicant is still over the income limit for a medical card, they are then assessed for a GP visit card, which entitles the applicant to GP visits without charge.

Under the Drugs Payment Scheme (DPS), no individual or family pays more than €80 a month towards the cost of approved prescribed medicines. The DPS is not means tested and is available to anyone ordinarily resident in Ireland. The DPS significantly reduces the cost burden for families and individuals with ongoing expenditure on medicines.

Individuals may also be entitled to claim tax relief on the cost of their medical expenses, including medicines prescribed by a doctor, dentist, or consultant. Relief is at the standard tax rate of 20%.

In April this year, I formally requested that the PSI develop guidance aimed at improving patient access to information on the fees that they pay for products they are dispensed and the services provided by community pharmacies.

I requested that this guidance include detail on:

• the range and quantum of professional service and dispensing fees charged (e.g. in a conspicuous location).
• at the point of dispensing on the range of professional service and dispensing fees and medicine/product costs charges to patients (e.g. itemised receipts), and the embedding of this approach into the PSI’s monitoring processes.

Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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2795. To ask the Minister for Health the reason octenisan is not included on the general medical scheme for those with medical cards and for whom this product is prescribed. [42003/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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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, the matter has been referred to the HSE for attention and direct reply to the Deputy.