Réada Cronin (Kildare North, Sinn Fein)
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696. To ask the Minister for Health his plans to ensure that gene immunotherapy will be made available free of charge to cancer patients; and if he will make a statement on the matter. [42586/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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In Budget 2025, I have secured €23 million for the National Cancer Strategy. This will deliver additional staff to screening and treatment services, expansion of existing screening programmes, and funding for community cancer supports.

Since its publication in 2017, over €105 million new development funding has been allocated to the National Cancer Strategy for cancer screening, prevention, and treatment services. A further €316 million has been allocated for cancer medicines. For 2025 I have allocated €10 million for cancer medicines, with a full year cost of €14 million.

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.

The State is committed to providing access to as many medicines and treatments as possible, in as timely a fashion as possible, from the resources available to it.

As per the 2013 Health Act, 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.