Clare Daly (Dublin Fingal, Independent)
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965. To ask the Minister for Health the reason Ireland is lagging behind other EU countries in the reimbursement of persons requiring new medicines which are routinely available across Europe; the obstacles preventing a more robust process; and if he will make a statement on the matter. [35907/17]

Simon Harris (Wicklow, Fine Gael)
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The 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.

The HSE makes reimbursement decisions on objective scientific and economic grounds. Criteria used 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. Most new medicines undergo HTAs, but not all applications have sufficient information for assessment. Also, as HTAs frequently cannot demonstrate value for money at the price sought, lengthy price negotiations may be needed. These factors contribute significantly to the length of the approval process.

Under the 2016 Framework Agreement on the Supply and Pricing of Medicines, the HSE may negotiate price and supply conditions. Reaching a sustainable pricing structure can be a long process. Put simply, some manufacturers, as monopoly suppliers, seek very high prices that may not reflect the drug’s effectiveness and that are unsustainable for our health service.

It is right to exercise diligence when considering such commitments. Every effort should be made to secure the best outcome for the patient, the health service and the taxpayer. This includes seeking realistic and sustainable pricing and supply models for new treatments.

Ireland has also begun working with other Member States to explore ways to share expertise and resources, so we can all gain access to new treatments in realistic time frames and at fair prices.