Louise O'Reilly (Dublin Fingal, Sinn Fein)
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875. To ask the Minister for Health when the demand for PD-L1 biological markers in the licensing of Pembrolizumab by the HSE will be removed for patients suffering from lung cancer; and if he will make a statement on the matter. [15894/18]

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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876. To ask the Minister for Health if the demand for PD-L1 biological markers in the licensing of Pembrolizumab by the HSE will be removed on a case-by-case basis for patients suffering from lung cancer; and if he will make a statement on the matter. [15895/18]

Jim O'Callaghan (Dublin Bay South, Fianna Fail)
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941. To ask the Minister for Health if the demand for PD-L1 biological markers in the licensing of Pembrolizumab by the HSE will be removed; and if he will make a statement on the matter. [16258/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 875, 876 and 941 together.

Neither the HSE nor the Minister for Health has any role in the licensing or authorisation of medicines in Ireland. Under European and Irish legislation, before a medicine can be placed on the Irish market, the manufacturer must seek a marketing authorisation from the Health Products Regulatory Authority (HPRA) or, in the case of certain medicinal products, the European Medicines Agency (EMA).

In the case of pembrolizumab, because of the biotechnology nature of the active substance involved, the drug was centrally authorised by the EMA. This authorisation covers several types of cancer, including non-small cell lung cancer (NSCLC) when the tumour produces a protein known as PD-L1.

In order to amend the authorisation of pembrolizumab, the company which holds the marketing authorisation would need to submit a case and supporting data to the EMA.

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. It is a pre-requisite that any new medicine submitted to the HSE for reimbursement must first hold a marketing authorisation granted by the HPRA or the EMA.