The State is committed to providing timely access to new and innovative medicines to all patients. Budgets 2021 to 2025 allocated an additional €158 million for new medicines, which has facilitated the introduction of 238 new medicines. 91 of these are for treating cancer as well as 55 for rare diseases.
In 2024, the HSE launched an application tracker to increase transparency in the medicines assessment process. In addition, the 34 staff allocated in Budget 2024, have been hired across the pricing and reimbursement process. These measures will enable the assessment of a greater number of medicines at a quicker pace and ensure patients can easily remain informed of progress.
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 from the European Medicines Agency (EMA), 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 are not able to add a new medicine to the reimbursement list until an application is received.
The Minister for Health regulates the community rated private health insurance market in Ireland. This is a voluntary market, which operates under principles including minimum benefits, requiring insurers to offer a minimum level of cover in every insurance policy. Health insurance companies may exclude or include certain services and providers in their policies, provided they remain in compliance with the Minimum Benefit Regulations. Beyond Minimum Benefits regulations, the Minister has no role to play in the commercial decisions of any health insurer.