Colm Brophy (Dublin South West, Fine Gael)
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540. To ask the Minister for Health the average time it takes for a drug to go through the reimbursement assessment process; the reason a delay exists; and if he will make a statement on the matter. [24744/17]

Simon Harris (Wicklow, Fine Gael)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Colm Brophy (Dublin South West, Fine Gael)
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541. To ask the Minister for Health his views on whether the current manner in which drugs are assessed for reimbursement by the HSE is adequate and appropriate; and if he will make a statement on the matter. [24745/17]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria to be applied in the making of decisions on the reimbursement of medicines. The Act does not confer any powers on the Minister for Health in this regard and the HSE does not require the approval or consent of the Minister or Government when making a decision.

Decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) of pharmaceutical products for the HSE, and makes recommendations on reimbursement to assist the HSE in decision-making. The NCPE uses a decision framework to systematically assess whether the drug is cost-effective as a health intervention.

A new Framework Agreement on the Supply and Pricing of Medicines 2016-2020 was signed on 20 July 2016. This Framework Agreement incorporates the statutory requirements of the 2013 Act for reimbursement decisions on new medicines.

I am satisfied that the current reimbursement process is open and transparent.