Carol Nolan (Laois-Offaly, Independent)
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732. To ask the Minister for Health if gene therapy is available for persons diagnosed with Duchenne muscular dystrophy; if there are plans to make it available, as per the situation in the United States, the United Kingdom and a number of other jurisdictions; and if he will make a statement on the matter. [42744/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE must comply with the relevant legislation when considering investment decisions around new medicines. Pharmaceutical companies are required to submit formal applications to the HSE if they wish their medicines to be added to the list of reimbursable items / funded via hospitals. In order to submit a formal application the medicine must hold a marketing authorisation. The European Medicines Agency (EMA) is a centralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA plays an integral role in the authorisation of medicines in the EU. The national assessment and reimbursement decision process cannot commence in the absence of a marketing authorisation.