John Lahart (Dublin South West, Fianna Fail)
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791. To ask the Minister for Health further to Parliamentary Question No. 235 of 2 October 2024, her views on whether funding earmarked for new medicines was spent on existing medicines; whether she will issue a directive to the HSE to ensure all funding earmarked for new medicines is spent exclusively for that purpose; and if she will make a statement on the matter. [25228/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for pricing and reimbursement of new medicines.

The State has committed very substantial amounts of funds to the HSE to support new medicines (and new use of medicines) and continues to do so on an ongoing basis. Budgets 2021-2024 allocated dedicated funding for new drugs totalling €128 million. This has allowed the HSE to approve 194 new medicines including 74 new oncology drugs and 49 new drugs for rare diseases in that period. Budget 2025 allocated €30 million for new drugs to come from efficiencies to be identified by the HSE. Reimbursement is for licensed indications which have been granted marketing authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).

The HSE in its decision making considers the 5-year budget impact of each new medicine notwithstanding that the budget of the HSE is set on an annual basis. The year 1 costs of most medicines represent a fraction of the overall costs of those medicines when fully introduced.

In any single year there will be substantial uncertainty around the costs that will emerge in the year in question at the time that the budget is set.

On occasion, medicines expected to reach the market in a particular year at time of budget planning will not ultimately reach the market as they may fail to demonstrate that they satisfy the safety, efficacy and / or quality standards required to receive a market authorisation from the European Medicines Agency (EMA). In addition, any application from a market authorisation holder, may not occur in the year forecast in the horizon scan.

The full cost of new medicines (or new use of medicines) approved will never emerge within the first calendar year of reimbursement approval, given some of those approvals will be effective in Q1, some in Q2 (i.e. partial year costs), some in Q3 (i.e. less than half year costs) and some in Q4 (with little or no costs in that calendar year but substantial and growing costs in the next year).

In addition, the HSE undertakes commercial negotiations for new drugs on behalf of the State to deliver substantial savings in the medicines budget, thereby creating financial headroom to maximise budget utilisation.

The HSE is committing all resources as allocated to the provision of new medicines over time, notwithstanding any inter-year variations.