Michael McGrath (Cork South Central, Fianna Fail)
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348. To ask the Minister for Health the number of medicines that the HSE has notified his Department that it does not have sufficient funds in its budget to reimburse; the number of medicines he has sent to Government for reimbursement approval since August 2016; and if he will make a statement on the matter. [22712/17]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines through the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria to be applied by the HSE in the making of decisions on the reimbursement of medicines. The 2013 Act prohibits the HSE from making a relevant decision except in accordance with these criteria.

While not provided for in legislation, applications may also be made by a manufacturer to the HSE to have a medicine priced as a hospital medicine for the purposes of supply to or reimbursement by the HSE, State-funded hospitals and related agencies. The HSE follows the same assessment and decision making process as set out in the Act for such medicines.

The Framework Agreement on the Supply and Pricing of Medicines 2016 (IPHA Agreement) sets out HSE guidance on how the HSE and related bodies will endeavour to engage with Companies submitting applications for reimbursement. The following provision is included:

- "12 In a situation where the HSE cannot fund the medicine from within existing resources, it may inform the Department of Health of its decision in this respect. The Department of Health may, as it deems appropriate, bring a memorandum to Government in relation to the funding implications and requesting consideration of same."

The full HSE guidance is available at: .

In line with this process, between 1 August 2016 and 12 May 2017, the HSE has informed the Department of Health that it cannot fund three medicines from within existing resources. The most recent notification was received on 12 May 2017. To date one of these medicines has been subject to a memorandum to Government in relation to the funding implications, one has been received in recent days and the other is subject to ongoing discussions between the Department and the HSE.

Prior to 1 August 2016 the HSE notified my Department in relation to one medicine and a memorandum was brought to Government in relation to the funding implications of this medicine.

Such memorandums relate to the funding implication only. The final decision on the pricing and reimbursement of all medicines remains the statutory responsibility of the HSE.