Bernard Durkan (Kildare North, Fine Gael)
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186. To ask the Minister for Health his plans to make available at reasonable cost various drugs now available on the market; and if he will make a statement on the matter. [48445/17]

Simon Harris (Wicklow, Fine Gael)
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The Health Service Executive (HSE) has statutory responsibility for decisions on the pricing and reimbursement of medicines, under the Health (Pricing and Supply of Medical Goods) Act 2013. The 2013 Act specifies the criteria to be applied in making decisions on the reimbursement of medicines.

The HSE seeks, where possible, to give patients early access to new treatments. However, it must work within the budget provided by the Oireachtas. In the statutory reimbursement process, supported by the 2016 Framework Agreement with industry, the HSE makes decisions on objective scientific and economic grounds. Criteria which must be considered include the population’s health needs, the product’s cost and clinical effectiveness, opportunity costs, the budget impact and available resources.

HSE decisions are supported by health technology assessments (HTAs), which systematically assess whether a drug is a cost-effective health intervention. Currently, most new medicines, including orphan products, undergo HTAs. However, not all applications have sufficient information for assessment and in such cases this must be sought. Also, as HTAs frequently cannot demonstrate value for money for items at the price sought by the company, lengthy price negotiations between the HSE and the manufacturer may be needed. These factors contribute significantly to the length of the reimbursement decision making process.

With the potential costs involved and the competing demands across the health service, every effort must be made to secure the best outcome for the health service and the taxpayer. This includes seeking realistic and sustainable pricing and supply models for new treatments.