Paul Murphy (Dublin South West, Solidarity)
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782. To ask the Minister for Health if she is aware of the fact that a number of new medicines are being made available through private healthcare providers, while public patients are made to wait for these to become available (details supplied); if she will instruct her Department to ensure that lifesaving medication is made available to all patients; and if she will make a statement on the matter. [25155/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines in Ireland, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The State acknowledges the importance of access to medicines and has made considerable investments in new medicines in recent years. Budgets 2021-2024 allocated dedicated funding for new drugs totalling €128 million (including €10 million from savings generated in 2024). This has supported the approval of 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).

In making a reimbursement decision, the HSE is required, under law, to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. An external review of the reimbursement process, published in 2023, found it to be operating in line with international norms.

While many pharmaceutical companies engage proactively with the HSE, Ireland may not always be prioritised by some companies in the first stages of marketing a new medicine. The HSE is obliged by statute to await a pharmaceutical company making an application to Ireland for its drug to be assessed before it can consider it for reimbursement. Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this an important factor, as statutorily, the HSE are not able to add a new medicine to the reimbursement list until an application is received.

Additionally, the initial commercial offering from manufacturers for medicines can have significant implications for the negotiation process, including its duration. In the context of a finite health budget, it is vital that the State ensures good value for money for public expenditure, and to ensure that the available budget maximises as much access as possible to medicines and other healthcare services for patients. Budget implications and commitments often represent multimillion-euro investments over several years and can lead to protracted engagement with companies to secure the information needed to make a decision.

In the second half of 2024 an additional 34 staff were recruited to enhance capacity across the pricing and reimbursement system. This further investment will support improvements in the process. Ireland encourages timely applications for reimbursement with reasonable pricing offers. We are confident that this will support improved access to medicines in Ireland, including in the area of oncology.

As Minister for Health, I regulate the private health insurance market. This is a voluntary market, which is underpinned by certain principles, including minimum benefit, that are set out in law. The Health Insurance Act 1994 (Minimum Benefit) Regulations 1996 require insurers to offer a minimum level of cover to every insured person. I do not have a role in the commercial decision-making of any private health insurer.