Dáil Éireann Debate, Tuesday - 3 March 2026
917. Deputy Ken O'Flynn asked the Minister for Health the date on which the review of the medicines reimbursement process, as committed to in the Programme for Government, will commence; whether terms of reference has been agreed; whether those terms will explicitly include the assessment and reimbursement framework for orphan medicines; when the review is expected to conclude; and if she will make a statement on the matter. [16943/26]
Amharc ar fhreagra920. Deputy John Paul O'Shea asked the Minister for Health when she intends to commence a review of the reimbursement process, as committed to in the Programme for Government; whether such a review will specifically include the way in which orphan medicines are assessed and reimbursed; and if she will make a statement on the matter. [16948/26]
Amharc ar fhreagra934. Deputy Ken O'Flynn asked the Minister for Health her plans to commence a review of the reimbursement process, as committed to in the Programme for Government; whether such a review will specifically include the way in which orphan medicines are assessed and reimbursed; and if she will make a statement on the matter. [16987/26]
Amharc ar fhreagraI propose to take Questions Nos. 917, 920 and 934 together.
The Government recognises the importance of access to new and innovative medicines for patients and is committed under the Programme for Government (Securing Ireland's Future) to a suite of measures on medicines which my officials seek to progress over the lifetime of this government.
In line with these commitments, consideration is bing given to various measures to address access to medicines. The Department is reviewing reimbursement systems across the EU to explore options for recommendation to Government and this work is ongoing.
Budgets 2021 to 2025 allocated €158 million towards new drugs. Budget 2026 allocated €30 million in funding for new drugs from a €217 million increase in medicines funding. This has allowed the HSE to approve reimbursement for 250 new medicines of which 101 new medicines were for cancer and 69 new medicines for rare diseases. The OECD reports that Ireland has the third highest rate of state coverage of pharmaceutical expenditure in Europe.In 2024 significant additional funding was allocated by Government for additional staff across the pricing and reimbursement system and the introduction of an application tracker by the HSE to support transparency. 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). 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. 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. All medicines are considered for pricing and reimbursement in order of application. 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. 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. Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor and misrepresent the process. Access to medicines requires industry and the State to work together, through timely assessment, reasonable pricing and fully prepared health technology assessment dossiers being submitted by a company to the HSE.
