Mary Butler (Waterford, Fianna Fail)

I thank the Deputy and I acknowledge his constant advocacy with regard to new cancer drugs and drugs in general. I am taking this question on behalf of the Minister, Deputy Carroll MacNeill.

As the Deputy knows, 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 licensed indications that have been granted marketing authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

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. There are formal processes that govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded or reimbursed or both.

An external review of this process, published in 2023, found it to be operating in line with international norms. In the same year, 50% of applications for reimbursement progressed following a rapid review without the need for a full health technology assessment. Recommendations made in the review have been implemented. These include the introduction of an application tracker to enhance transparency within the pricing and reimbursement process and enhancing the capacity across the process with the recruitment of 34 additional staff.

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 unless 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.

The State acknowledges the importance of access to medicines and has made considerable investments in new medicines in recent years. In 2023, a record €3 billion of public funding was spent on medicines for patients in Ireland, so it is not that we are not spending a huge amount of funding on drugs. This €3 billion out of the full budget represents almost €1 of every €8 spent by the State on healthcare. In the last three years, over €645 million was spent on medicines to treat patients with cancer, and investment in such treatments continues to be a priority. I take on board the statistics the Deputy articulated at the start, and I will bring them to the attention of the Minister.

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