John Paul Phelan (Carlow-Kilkenny, Fine Gael)
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361. To ask the Minister for Health the amount of the €50 million funding allocated to the approval of new medicines in Budget 2021 and the €30 million Budget 2022 that was spent on the approval of new medicines; the amount that was not spent from the allocation in each respective fiscal years; and if he will make a statement on the matter. [50795/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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€50 million in funding was allocated for the approval of new medicines in Budget 2021, €30m in 2022, and a further €18 million in Budget 2023 which will provide access to new innovative medicines for patients.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for pricing and reimbursement negotiations and decisions on all new drug applications.

Through HSE commercial negotiations, in 2021 the State managed to secure approval for 52 new drugs, under budget, at a cost of €34.39 million. This included 19 drugs, that were for the treatment of rare diseases. The full year cost of approvals in 2021 will far exceed the €34.39 million expended in 2021, and the funding for these medicines in subsequent years has to be built into the annual HSE medicines budget.

The exact number of new drugs approved for 2022 is not yet available, as pricing and reimbursement negotiations are ongoing between the HSE and a range of applicant companies.