Thomas Gould (Cork North Central, Sinn Fein)
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687. To ask the Minister for Health if an official group has been established to review the codeine prescription processes; the membership of this group; the parameters of the group; the date of its establishment; and the date that the group will report back. [53433/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Department of Health and its agencies are actively monitoring the evolving evidence in relation to codeine-containing medicines, including the merits of any necessary further steps to support the safe and effective use of these medicines.

The Health Products Regulatory Authority, the competent authority for medicines in Ireland, are currently conducting an independent review of the method of sale and supply of codeine-containing medicinal products that are currently available without a medical prescription.

Following its completion, the Department will engage with relevant stakeholders to assess the recommendations made, including the recent recommendations from the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), to fully consider any policy changes that may be required regarding the regulation of codeine-containing medicinal products.

Neale Richmond (Dublin Rathdown, Fine Gael)
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688. To ask the Minister for Health if his attention has been drawn to Ireland's proportionate spend on medicines which is decreasing in relation to other countries; if a process is in place to monitor same; if he will take steps to address the matter; and if he will make a statement on the matter. [53434/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Spending through the community drugs schemes is monitored and reported by the HSE’s Primary Care Reimbursement Service (PCRS).

The HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available to it. To make this possible, I have secured €23.4b in funding for our health services in Budget 2023. This is the third year in a row that funding has set a new record.

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 NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug's clinical and cost effectiveness as a health intervention.

Multiple initiatives exist to try to ensure value for money in the medicines purchased. These include the Framework Agreements on the Supply and Pricing of Medicines 2021-2025, a set of Agreements negotiated with Industry to provide medicines for the HSE at sustainable prices. These are expected to lead to between €600m-700m less being spent on medicines over the course of the deals. The extra headroom provided by these deals will allow the HSE to do more with their resources.

The pipeline of new medicines coming to market remains strong and this government wants to secure fast access to medicines for our patients. Dedicated funding for new drugs was allocated in the past three budgets, totalling €98m. This has enabled the HSE to approve reimbursement for new drugs and new indications of existing drugs in a timely manner, with 52 approvals in 2021 and 46 to date in 2022.

Neale Richmond (Dublin Rathdown, Fine Gael)
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689. To ask the Minister for Health the amount that has been spent treating patients abroad via the treatment abroad scheme with CART since 2019; the number of medicines for CART that were being assessed during this window; if consideration has been given to the way to increase the efficiency of this approvals process in view of this information; and if he will make a statement on the matter. [53435/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.