In Ireland cancer remains one of the leading causes of death. Timely access to new and effective treatments is crucial for improving the survival rates and the quality of life for patients. However, delay in accessing these treatments has become a significant issue, adversely impacting patients' health and survival rates. Currently the approval process for cancer drugs in Ireland involves prolonged assessments by bodies such as the Health Products Regulatory Authority and the National Centre for Pharmacoeconomics.

Yet, this is after these drugs have already been evaluated for both safety and effectiveness by the European Medicines Agency. As a result, these lengthy and complex approval processes lead to significant delays. According to IDA Ireland, this country is the third largest net exporter of pharmaceuticals in the world. However, it is one of the slowest countries in Europe to make these innovative medicines available to Irish patients. The wait in Ireland for new cancer drugs is, on average, 673 days post authorisation by the European Medicines Agency. That is 22 months. In contrast, other EU countries can make these medicines available to patients in as few as 102 days while still managing budgets and conducting value-for-money assessments. It is important to note that it is only public patients who are left waiting for two years or longer for access to these new medicines. This widens the divide in Ireland's two-tier health system because patients with health insurance can have immediate access to many of these drugs once they are approved by the European Medicines Agency.

If we are serious about delivering on Sláintecare and ensuring that patients receive treatment based on their medical needs, we must raise the access public patients have to lifesaving drugs to the accessibility standard of patients with private health insurance. At least in part, these delays are due to inadequate staffing, resulting in files sitting on desks awaiting assessments, or what is known as “processing dead time”. Tragically, there could not be a more apt phrase because, in reality, these delays mean that patients, particularly those with aggressive or advanced cancers, may not receive potentially lifesaving drugs in time. Consequently, their chances of survival diminish, and their quality of life deteriorates. By addressing these unacceptable delays, we can ensure that patients receive the timely and effective treatment they deserve, improving their chances of survival and quality of life.

I thank Deputy Naughten for raising what is a very important issue. The first point I want to make is that the Government is committed to ensuring that patients in Ireland get timely access to new and innovative medicines. In my time in the Department of public expenditure and reform, this was an issue on which we consulted and worked very closely with the Minister for Health, Deputy Donnelly, and his Department. We provided ring-fenced funding to ensure that new medicines could be made available in Ireland.

Some 148 new medicines have been approved in the past three years. That is based on the €98 million in new medicines funding, with total expenditure of €327.5 million to the end of 2023. This has facilitated the introduction of 61 new cancer medicines in Ireland, bringing the total spend on cancer drugs in the last three years to more than €600 million. For example, in 2021, we provided €50 million of ring-fenced funding that allowed 52 medicines to be approved, half of which were for cancer. In 2022, there was a further €30 million and that allowed 60 medicines to be approved, 18 of which were for cancer. Last year, of €18 million in funding, 36 medicines were approved, 17 of which were for cancer. Of course, that funding goes into the base. That is permanent funding that recurs every year. Once a particular medicine is approved, it is essentially demand-led and the funding will be provided to meet that demand. Therefore, that funding is in the base.

The Deputy made a relevant point in respect of staffing. We have provided an additional 34 staff across the pricing and reimbursement process. Funding in that regard was provided in the budget last autumn. This year, the HSE will launch an application tracker to increase transparency in the medicines assessment process.

There is very close collaboration and a very good working relationship between Government and industry on this issue. The Irish Pharmaceutical Healthcare Association engages on an ongoing basis with the Department of Health. This issue is raised with me by IDA Ireland clients when I meet with them. I am satisfied that the work is well under way and that the progress we have made so far will be built upon. We will continue to improve access to new, innovative medicines here in Ireland, including those for cancer.

When we look at the overall numbers, as I am required to do in my job, we can see that almost €3 billion is being spent on new, better medicines. It is therefore vital that the HSE robustly assesses offers from industry and that it maximises the use of its resources to purchase as many new medicines as possible. That work will continue.

Patients with rare diseases face even greater challenges in accessing new treatments or orphan drugs, as they are often called. On average, they wait nearly 26 months. This delay is especially tragic, as approximately 30% of children with a rare disease will pass away before their fifth birthday. The impact of these delays on patients with rare diseases is profound. How can we defend a situation where these children may wait up to half of their short lives to access Irish-manufactured medications that could prolong their lives? We must prioritise the needs of patients with rare diseases and ensure that they receive timely access to treatments that could offer them the best hope of quality time with their loved ones. Why not use the access for these children to these vital drugs as a pilot case to resolve the blockages in accessing Irish-manufactured drugs for Irish patients? By doing so, we can make a significant difference to their lives and to those of their families.

This is a priority area for the Government. It is one that I am very familiar with. I know very well of companies, such as BioMarin Pharmaceutical Inc., which operates in my constituency in Cork and which focuses on the manufacturing of drugs for rare diseases, namely, orphan drugs. We engage with it and others in the industry on an ongoing basis because we want to ensure that people who are afflicted by very rare diseases and young children whose life expectancy may be limited get access to those drugs as quickly as possible. My role is to ensure that we provide the appropriate funding to achieve that.

Ireland ranks second among OECD countries for the proportion of pharmaceutical expenditure which is covered by the State. We are working to improve the efficiency and the speed of decision-making. We can only make progress on this once companies actually apply through the Irish system, once they have received the necessary authorisation from the European Medicines Agency. This issue is being actively managed. We are making progress and we will continue to focus on that.