Dáil Éireann Debate, Thursday - 2 October 2025
461. Deputy Ken O'Flynn asked the Minister for Health the steps being taken to accelerate the availability of oncology generics and biosimilars to reduce cost barriers for the public health system; and whether legislative or regulatory reform is being considered in this regard. [52832/25]
Amharc ar fhreagraThe Government recognises the importance of timely access for patients to new medicines. The Programme for Government contains a suite of measures on medicines, which we aim to progress over its lifetime. Access to medicines is the focus of a number of workstreams across my Department.
Budgets 2021-2025 allocated an additional €158 million for new drugs, which facilitated the introduction of 238 new medicines in that period. 97 of these are for use in oncology. 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 2023 a review of the drug reimbursement process was published. It found that the process was operating as intended and within international norms. Recommendations from the review have now been implemented. A pricing and reimbursement application tracker has been launched to improve transparency. In 2024 an additional 34 staff were recruited to enhance capacity across the pricing and reimbursement system.
Access to medicines requires industry and the State to work together, through timely assessment, and reasonable pricing with fully completed HTAs (Health Technology Assessments). The Government encourages pharmaceutical companies to submit timely applications for reimbursement.
My Department is looking at reimbursement systems across the European Union and working closely on access to medicines with Beneluxa partners, where we have had previous success.
As outlined in the Programme for Government, consideration will be given to early access mechanisms for medicines. These mechanisms and their effects are complex and must be evaluated carefully.
