Patricia Ryan (Kildare South, Sinn Fein)
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688. To ask the Minister for Health his plans to introduce legislation to facilitate substitution by a pharmacist from a biological reference product to a biosimilar; and if he will make a statement on the matter. [31450/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Department of Health is fully supportive of domestic policies that maximise efficiency in our medicines usage. The HSE is actively engaged in implementing effective policy levers across a number of domains and under several initiatives, including programmes under the Acute Hospitals Drugs Management Programme (AHDMP), the Medicines Management Programme (MMP), and within the Primary Care Eligibility & Reimbursement Service (PCERS).

The AHDMP has a biosimilar strategy in place since 2017. This is making considerable progress using a collaborative approach to bring about changes in prescribing practice.

The MMP completed an evaluation process in 2019 for the identification of the best-value biological (BVB) medicines for TNF-α inhibitors under the High-Tech Drug arrangements. In June 2019, a system of gain-share was introduced and is administered by the PCERS with the objective of encouraging the prescribing of the BVB medicines. This has been largely successful in increasing uptake of these medicines. By year-end, the initiative is on track to deliver approximately €42m in savings, with 2021 full year savings projected to be in the region of €50 – 80 million.

While progress has been positive, the Department of Health and HSE are continuously monitoring and evaluating the effectiveness of current levers to ensure that the State can capitalise on the most efficient policy approach.