Bríd Smith (Dublin South Central, People Before Profit Alliance)
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304. To ask the Minister for Health the reason melatonin and propranolol are not covered by a student medical card while venlafex, which has been prescribed as part of a trio of medication, is; if his attention has been drawn to the fact that having to pay for these two medications is having a significant financial impact, especially when other college costs are also factored in; if there are any other supports or schemes a student can access to cover the cost of their medications; and if he will make a statement on the matter. [10748/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Health 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. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

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 by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). I, as the Minister for Health, have no role in these decisions.

The HSE advise that Melatonin (Circadin) has never been available through the Reimbursement List under the Community Drug Schemes. Melatonin (Circadin) underwent a review in 2008 and reimbursement was not recommended by the NCPE as there was insufficient evidence to support the reimbursement of this product under the Community Drug Schemes (available at www.ncpe.ie/drugs/melatonin-circadin/). 

Exceptional arrangements are, however, considered under Section 23 of the Health (Pricing and Supply of Medical Goods) Act 2013 - Supply of items not on the Reimbursement List. An application for melatonin can be considered on an exceptional basis under Discretionary Hardship Arrangements for medical card holders. All applications under these arrangements are reviewed on an individual patient basis under Section 23. A reimbursement form is required to be completed and submitted by the prescribing consultant and contain sufficient information to enable a positive decision. The HSE must be satisfied that:

(a)The patient requires that item for clinical reasons, and

(b) There is no listed item which is a suitable alternative for that item in so far as that patient is concerned.

Propranolol products were discontinued by the various Marketing Authorisation Holders in recent years. However, reimbursement support has been provided for Exempt Medicinal Products (EMPs) which are unlicensed in Ireland, on an individual patient basis whereby alternative therapeutic options on the Reimbursement list have been exhausted and there is an unmet clinical need.The following Exempt Medicinal Products are available:

- Propranolol (ULM) Oral Soln. 50mg./5ml. 150ml.

- Propranolol (ULM) Tabs. 40 mg. 50.

- Propranolol (ULM) Tabs. 10 mg. 28.

- Propranolol (ULM) Tabs. 10 mg. 100.

The Drug Payment Scheme (DPS) provides for the refund of the amount by which expenditure on approved prescribed medicines or medical and surgical appliances exceeds a named threshold in any calendar month. The DPS is not means tested and is available to anyone normally resident in Ireland.

The DPS threshold is currently €80 per month. The DPS significantly reduces the cost burden for families and individuals with ongoing expenditure on medicines.

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