Bernard Durkan (Kildare North, Fine Gael)
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515. To ask the Minister for Health the procedures in place to encourage manufacturers of medicines to make their product available for sale to the health service at a manageable cost with particular reference to top of the range new products with an expensive price tag; and if he will make a statement on the matter. [28253/19]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions under the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies criteria for decisions on the reimbursement of medicines. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines.

If a company wishes to have a medicine reimbursed, it must apply to the HSE to have the product added to the Reimbursement List. It is the sole responsibility of the company to make this application.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, including the advice of the National Centre for Pharmacoeconomics (NCPE).

The NCPE conducts health technology assessments for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess the cost and clinical effectiveness of the drug as a health intervention at the submitted price.

Where the submitted price for a product does not reflect cost effectiveness, the applicant may enter further discussions with the HSE. This can lead to an protracted deliberation process. However, the HSE, because of the significant monies involved, must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an ongoing basis.