Pat Buckley (Cork East, Sinn Fein)
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806. To ask the Minister for Health for greater clarity and urgency in addressing access to approved cancer medications in Ireland; and if she will make a statement on the matter. [27704/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The State is committed to providing timely access to new and innovative medicines to all patients. Budgets 2021 to 2024 allocated an additional €128 million for new medicines, which has facilitated the introduction of 194 new medicines. 74 of these are for treating cancer as well as 49 for rare diseases. This brings the total spend on cancer drugs in the last three years to over €645 million.

In 2024, the HSE launched an application tracker to increase transparency in the medicines assessment process. For 2025, the HSE will continue the tracker’s development with the introduction of indicative timelines for each step of a medicine’s assessment process in compliance with NSP 2025. In addition, the 34 staff allocated for the pricing and reimbursement system in Budget 2024, have been hired across the system.

These measures will enable the assessment of a greater number of medicines at a quicker pace and provide transparency to all stakeholders including patients around the status of the pricing and reimbursement application of a new treatment.

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 licenced 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 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 National Centre for Pharmacoeconomics (NCPE). There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed.

The timing of company applications for new medicine reimbursement in different countries can vary for several reasons, not least the available market share in each country.

Once a company responsible for the commercialisation of a new medicine receives marketing authorisation, it can apply for reimbursement in the country (or countries) of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product.

Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor and misrepresent the process, as statutorily the HSE is 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.

Ireland encourages all pharmaceutical companies to apply to the HSE to have their medicines added to the reimbursement list once granted marketing authorisation by the European Medicines Agency.