Irish Patients Face Lengthy Delays for Life-Saving Medications
Ireland is lagging behind its European counterparts when it comes to approving new medicines, leaving patients waiting months, and sometimes even years, for access to potentially life-saving treatments.
The Irish Pharmaceutical Healthcare Association (IPHA) has raised concerns over the lengthy approval process for new drugs, highlighting significant delays impacting patient access to vital medications. The association is calling on the next government to prioritize funding for the Health Service Executive (HSE) to meet the six-month target times outlined in legislation.
Currently, the initial stage of the process, where the HSE National Centre for Pharmacoeonomics (NCPE) typically sends preliminary review questions to pharmaceutical companies, is taking considerably longer than the stipulated timeframe. Analysis by the IPHA reveals an average waiting period of 192 days for this stage, more than triple the 60-day target.
Cancer drugs, critical for treating and potentially curing serious illnesses, are particularly affected by these delays. It currently takes an average of 232 days, or over seven and a half months, just for the NCPE to send initial review questions to companies developing new cancer medications. In some cases, the wait has stretched to over seven months, leaving patients and their families in limbo.
One company submitted a novel treatment for reducing the risk of heart disease in adults taking statin medication in November of last year. It wasn’t until September, almost a full ten months later, that they received their first set of questions.
Another new treatment, this one aimed at improving outcomes for kidney transplant patients, was submitted in April.
Despite the urgent need for this medication, the developmental team had to wait until September, over five months later, to receive those crucial first questions.
These stark delays aren’t isolated incidents. Numerous cancer drugs are facing prolonged review periods. One promising new drug for adults with a type of lymphoma was submitted in September of last year. The first questions arrived eight months later, in March.
Another crucial medication, designed for adults who cannot have chemotherapy, was submitted in January.
But by November, ten months later, the company still had not received those initial review questions.
These delays have a direct and devastating impact on patients who rely on timely access to new treatments. For those battling difficult illnesses like cancer or requiring life-saving medication like a new heart disease treatment, every day counts. The IPHA warns that delays can, in extreme cases, reach up to two years through all stages of the approval process.
These lengthy timelines persist despite the Health Act 2013, which mandates a 180-day limit for processing new drug applications. The IPHA emphasizes that other European Union countries faithfully adhere to this legislation, yet Ireland continues to fall short.
“Other EU countries comply with this law but the 180-day timeline is simply not being met in Ireland,” the IPHA stated. “The HSE is not being resourced to meet it. The process is not designed to achieve it. There are no performance indicators. There is no visibility or reporting on it.”
The IPHA suggests a solution: inviting doctors to play a role in prioritizing which medicines should be launched in Ireland after receiving European approval. This collaborative approach, they argue,
would encourage both industry and the State authorities to fulfill their roles efficiently and responsibly, ultimately leading
to improved patient care.
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“We are calling on the next Government to invite doctors to tell industry which medicines should be prioritised for launch in Ireland, once approved at European level, based on the needs of patients here.”
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“We believe this will spur on both industry and State authorities to fulfil their roles efficiently and responsibly in the best interest of advancing patient care.”
Oliver O’Connor, Chief Executive of the IPHA
Health Minister Stephen Donnelly defended the current system in July, citing a review report that concluded the reimbursement process was operating within legal parameters and delivering results in line with international norms.
“(The Mazars report) found that the reimbursement process is operating in line with the legislation and that it is delivering results in line with international norms,” he said.
What specific actions have been proposed by the Irish Pharmaceutical Healthcare Association (IPHA) to address the delays in drug approvals?
## Irish Patients Face Lengthy Delays for Life-Saving Medications: An Interview
**Interviewer:** Welcome to the program. Today we’re discussing the concerning delays in drug approvals in Ireland, leaving patients waiting for potentially life-saving medications. Joining us is [Guest Name], [Guest Title] at the Irish Pharmaceutical Healthcare Association (IPHA). Thank you for being here.
**Guest:** Thank you for having me.
**Interviewer:** Let’s start with the big picture. The IPHA has raised alarm bells about lengthy drug approval processes in Ireland. Can you give us a sense of the scale of this problem?
**Guest:** Absolutely. The situation is deeply concerning. Ireland is lagging behind other European countries when it comes to approving new drugs. Our research at the IPHA shows that, on average, it takes over 192 days for the HSE’s National Centre for Pharmacoeonomics (NCPE) to send its initial questions to pharmaceutical companies. This is more than triple the 60-day target! [[1](https://www.imt.ie/news/two-year-delay-in-approval-of-new-drugs-for-use-by-public-patients-08-03-2024/)]
**Interviewer:** And these delays have a particularly severe impact on patients with serious illnesses, correct?
**Guest:** That’s right. Cancer patients are disproportionately affected. It takes an average of 232 days – over seven and a half months – just for the NCPE to send its initial questions to companies developing new cancer treatments. We’ve seen cases where this stage alone takes over seven months. Imagine the anxiety and uncertainty faced by patients and their families waiting for that long for potentially life-saving treatments [[1](https://www.imt.ie/news/two-year-delay-in-approval-of-new-drugs-for-use-by-public-patients-08-03-2024/) ]
**Interviewer:** You mentioned specific examples. Can you share any of those?
**Guest:** Certainly. For instance, a novel treatment for reducing heart disease risk in statin users was submitted in November last year. It wasn’t until September – almost ten months later – that the first review questions were received. Similarly, a new treatment for improving kidney transplant outcomes submitted in April faced a five-month wait for those initial questions [[1](https://www.imt.ie/news/two-year-delay-in-approval-of-new-drugs-for-use-by-public-patients-08-03-2024/) ].
**Interviewer:** The IPHA is calling for action. What specifically needs to happen to address these delays?
**Guest:** The next government must prioritize funding for the HSE to ensure the NCPE can meet the six-month target outlined in legislation. Every day of delay potentially means another day without access to potentially life-saving treatment. We need a faster, more efficient system that puts patients first.
**Interviewer:** [Guest Name], thank you for bringing this critical issue to light.
**Guest:** Thank you for having me. It’s crucial that we raise awareness of this problem and work towards a solution.
