Colm Burke (Cork North Central, Fine Gael)
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787. To ask the Minister for Health the number of applications for managed access protocols, MAPs, medicines that have been approved or rejected in the past 24 months; how Ireland compares with other EU member states regarding the rates of approval for medicines covered by MAPs; and if he will make a statement on the matter. [24384/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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As the Health Service Executive (HSE) has statutory responsibility for the pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013, I have asked the HSE to respond to the Deputy directly, as soon as possible.

Colm Burke (Cork North Central, Fine Gael)
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788. To ask the Minister for Health the governance process for deciding on a managed access protocol for a new medicine; the criteria used to inform a managed access protocol; and if he will make a statement on the matter. [24385/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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As 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, I have asked the HSE to respond to the Deputy directly, as soon as possible.

Colm Burke (Cork North Central, Fine Gael)
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789. To ask the Minister for Health the access criteria for managed access protocols, MAPs, across all medicines; if he has considered whether there is sufficient transparency of the MAP process for patients and clinicians, particularly with regards to the rejection of applications; if MAPs should be amended if they are found not to be accommodating to clinicians and patients; and if he will make a statement on the matter. [24386/23]

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 under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

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

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 HSE Medicines Management Programme (MAP) has Managed Access Protocols in place for a number of medicines as part of the reimbursement approval process.MAPs are used to identify patients or subgroups of patients who would most benefit from the specific treatment approved for reimbursement and for whom the clinical evidence of therapeutic benefit is strongest.

Given the HSE's statutory responsibility under the 2013 Act, I have also asked the HSE to respond to the Deputy directly in respect of the access criteria for managed access protocols across all medicines, as soon as possible.