Marian Harkin (Sligo-Leitrim, Independent)

I thank Senator Costello for raising this issue. I will be answering on behalf of the Minister for Health, Deputy Carroll MacNeill.

The State acknowledges the importance of faster access to new medicines for patients. The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licensed indications that have been granted marketing authorisation by the EMA or the Health Products Regulatory Authority, HPRA. In making a reimbursement decision, the HSE is required under the Act to have regard to a number of criteria, including efficacy, the health needs of the public, cost-effectiveness and potential or actual budget impact.

HSE decisions on which medicines are reimbursed by the State via public funds are made on objective, scientific and economic grounds and having regard to the advice of the NCPE. Formal processes govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded or reimbursed.

The Senator mentioned the external review of the pricing and reimbursement process, the Mazars review, which was published in 2023. While this determined that the pricing and reimbursement process operated in line with international norms, a number of recommendations were made on foot of its findings.In the same year, 50% of applications for reimbursement progressed following a rapid review without the need for a full health technology assessment. Furthermore, 90% of generic and biosimilar medicines were approved for reimbursement within 90 days.

A number of these recommendations have now been implemented. One of the key recommendations of this review was enhancing the capacity across the pricing and reimbursement system, with significant funding allocated for 34 additional staff within the system. These 34 new staff have now been hired, of which 16 additional new staff were recruited and are now in place within the NCPE. This is a significant investment by the State and reflects the Government's commitment to providing access to new and innovative medicines to patients faster. The full impact of additional staffing within the NCPE on the speed of assessment of new medicine applications will become evident in the coming months. This additional capacity will significantly enhance and support the ability to appraise the increased volume and complexity of submissions from pharmaceutical companies for new drugs that are coming through the application process.

Another recommendation from this review was greater transparency for all stakeholders. A key focus was the implementation of a pricing and reimbursement medicines tracker to be developed by the HSE. The tracker has now been launched, with the initial iteration available since December 2024. In real time, this will show the status of a reimbursement application for a new medicine, from rapid review to a final decision by the HSE. Senator Costello asked about this. The HSE national service plan will continue the trackers' development with the introduction of indicative timelines for each step of a medicine's assessment process. That was the question the Senator specifically asked.