Grace Boland (Dublin Fingal West, Fine Gael)
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1867. To ask the Minister for Health if her Department still views the recommendations contained within a report (details supplied) relevant; whether she intends to act on these recommendations; and if she will make a statement on the matter. [12555/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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A new National Rare Disease strategy is under development and expected to be delivered in early 2025. It aims to provide a renewed focus on rare diseases, building on the work of the National Rare Disease Plan for Ireland 2014 - 2018, to meet the needs of people living with rare diseases, their families and healthcare professionals over the next five years.

In February 2024, the National Rare Disease Steering Group was tasked with developing the new National Rare Disease Strategy and an associated Implementation Plan. The vision of this strategy is to ensure that all people living with a rare disease, and their families, have access to equitable, inclusive, and cross-sectoral care throughout their life journey that will enable them to reach their full potential and to live their best lives.

A record of over €3 billion, nearly €1 in every €8 of public funding spent on health, was spent in 2023 on medicines. This is an unprecedented level of investment in supporting patients through the availability of the latest and wide range of medicines.

The State has made an additional €128 million available for new drugs between 2020 and 2024. Up to November 2024, this has seen 194 new medicines approved for reimbursement by the HSE including 74 oncology drugs and 46 orphan medicines for rare diseases.

For 2025 an additional €30m will be made available for new drugs funding, through efficiencies identified by the joint DOH-HSE Medicines Sustainability Taskforce. The Department of Health, the HSE and all relevant agencies and stakeholders place a priority focus on achieving the most efficient and effective use of available resources. This ensures that the substantial investment in medicines is maximised to treat even more patients with new innovative therapies in the years to come.

Once a company responsible for the commercialisation of a new medicine receives marketing authorisation from the European Medicines Agency (EMA), it can apply for reimbursement in the country (or countries) of its choice. Ireland encourages all pharmaceutical companies to apply to the HSE to have their medicines added to the reimbursement list.

Along with increased investment in the budget for new medicines, the previous Minister for Health published the Mazars Report in 2023 which found that the HSE Pricing and Reimbursement system was operating as intended and within international norms.

Amongst its observations, the report recommended the introduction of a Medicines Reimbursement Application Tracker to demonstrate how a medicine is progressing through the process. This will enhance transparency for patients and provide applicant companies real time visibility on a new medicine application. The tracker was launched in December 2024.

As recommended in the Mazars Report, the Government allocated significant funding for an additional 34 WTE for the agencies involved in the HSE’s medicines pricing and reimbursement system. These additional staff will allow each agency to operate to its full potential, ensuring timely and efficient assessment of applications.