Seán Sherlock (Cork East, Labour)
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394. To ask the Minister for Health if his attention has been drawn to the case of a drug (details supplied); and if he will make a statement on the matter. [19019/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The 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 licenced 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). The Minister for Health has 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/).

The HSE received an application for the pricing and reimbursement of Melatonin (Slenyto) 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.

On 31 July 2019, the HSE requested that Flynn Pharma submit a rapid review dossier to the NCPE for assessment. To date Flynn Pharma has not submitted a rapid review dossier to the NCPE for assessment. 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.

It is important to note that section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

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%.