Joe Carey (Clare, Fine Gael)
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772. To ask the Minister for Health the way in which his Department has engaged with industry to explore ways in which new medicines can be more easily introduced here; his plans to update statutory provisions in place regarding the matter; and if he will make a statement on the matter. [25060/18]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the 2013 Act. The Act specifies the criteria for decisions on the reimbursement of medicines.

The 2013 Act does not give the Minister for Health any powers in this regard.  The HSE does not require approval or consent from the Minister or Government when making a reimbursement decision.

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 whether a drug is cost-effective as a health intervention.

The HSE works with the objective of within 180 days of receiving the application (or a longer period if further information is sought from the company), either:

adding the medicine to the reimbursement list or agreeing to reimburse it as a hospital medicine,

refusing to reimburse the medicine.

The HSE strives to reach a decision in as timely a manner as possible and within the 180 days. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an on-going basis. This can lead to a protracted deliberation process, especially when the price sought by a manufacturer poses very significant affordability challenges.

My Department is undertaking initial scoping work as a precursor to engagement with stakeholders.