Peter Burke (Longford-Westmeath, Fine Gael)
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231. To ask the Minister for Health if he will direct the HSE to provide lifesaving medication to a person (details supplied); and if he will make a statement on the matter. [26192/17]

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

In line with the 2013 Act, if a Company would like a medicine to be reimbursed by the HSE pursuant to the Community Drug Schemes or as a hospital medicine, the Company must first submit an application to the HSE to have the new medicine added to the Reimbursement List or to be priced as a hospital medicine.

It is a pre-requisite that any new medicine applying to be reimbursed by the HSE must first hold a marketing authorisation granted by the Health Products Regulatory Authority (“the HPRA”) or the European Medicine Agency.

Pembrolizumab is not licensed for the treatment of metastatic colorectal cancer. The unlicensed use of medicines is a matter for a patient's clinician and the treating facility.

Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.