Ireland Lagging Behind: Drug Approval Delays Threaten Patient Access
Irish patients are facing wait times of up to two years for new medicines, putting them at a significant disadvantage compared to their counterparts in other European Union countries. The Irish Pharmaceutical Healthcare Association (IPHA) has issued a stark warning, calling on the upcoming government to prioritize reforms to the drug approval process.
The IPHA recently conducted an analysis revealing alarming delays at various stages of the drug approval process in Ireland. This analysis points to a systemic issue within the Health Service Executive’s (HSE) National Centre for Pharmacoeconomics (NCPE), resulting in lengthy waiting periods that negatively impact patient access to potentially life-saving treatments.
A System in Need of Reform
Under the Health Act 2013, the HSE is obligated to make decisions on new drug applications within a six-month timeframe. However, the IPHA’s research shows that this target is not being met.
- The initial step, where the NCPE sends preliminary review questions to pharmaceutical companies, is already taking an average of 192 days (over six months).
- For cancer drugs, this stage alone takes an average of 232 days (over seven and a half months).
These delays are not isolated incidents, with numerous examples highlighting the severity of the problem:
- A new treatment for reducing heart disease risk in statin-taking adults, submitted in November 2022, took 322 days to receive its first questions.
- A new kidney transplant treatment, submitted in April 2023, faced a 147-day wait for initial queries.
Cancer patients are particularly affected, enduring agonizing delays for potentially life-saving medications:
- A lymphoma treatment submitted in September 2022 waited 177 days for its first questions.
- Another cancer drug for patients unable to undergo chemotherapy, submitted in January 2023, had still not received initial queries by November 20th, a delay of 279 days.
These are just a few examples highlighting a worrying trend: delays across the drug approval process can accumulate to as much as two years.
Calls for Urgent Action
The IPHA emphasizes that these unacceptable delays are not a reflection of European-wide standards.
"Other EU countries comply with this law, but the 180-day timeline is simply not being met in Ireland," states the IPHA.
“The HSE is not being resourced to meet it. The process is not designed to achieve it. There are no performance indicators, no visibility, and no reporting on it."
The IPHA proposes several actionable solutions, urging the incoming government to prioritize:
- Increased funding for the HSE to meet the six-month target times stipulated in the Health Act 2013.
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Process optimization: restructuring the drug approval process to enhance efficiency and accountability.
- Transparency and data sharing: Implementing performance indicators and publicly reporting on the progress of drug applications.
- Prioritization based on clinical need:
Involving healthcare professionals in identifying which medicines should be prioritized for launch in Ireland, based on the specific needs of Irish patients.
Oliver O’Connor, Chief Executive of the IPHA, highlighted the importance of collaborative action:
“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."
The urgency of this issue cannot be overstated. The current delays jeopardize the well-being of countless Irish patients who desperately need access to life-changing treatments. It’s time for a systemic overhaul to ensure that Ireland’s drug approval process aligns with international best practices and prioritizes the health and well-being of its citizens.
What are your thoughts on these proposed solutions? Share your perspective in the comments below and let’s start a conversation about improving the healthcare landscape in Ireland.
* What specific measures can be implemented to optimize the drug approval process in Ireland and ensure it meets the six-month timeframe mandated by the Health Act 2013?
## Ireland’s Drug Approval Delays “Unacceptable” – An Interview with IPHA CEO Bernard Mahon
**World Today News** sat down with Bernard Mahon, CEO of the Irish Pharmaceutical Healthcare Association (IPHA), to discuss the alarming delays in Ireland’s drug approval process and the urgent need for reform.
**WTN:** Mr. Mahon, the IPHA’s recent analysis paints a concerning picture of lengthy delays in getting new medicines to Irish patients. Can you elaborate on the extent of the problem?
**BM:** Absolutely. The analysis revealed systemic delays at multiple stages of the drug approval process. The Health Act 2013 mandates a six-month timeframe for decisions on new drug applications. Regrettably, this target is consistently unmet. For example, the initial step, where the NCPE submits preliminary questions to pharmaceutical companies, takes an average of 192 days, already exceeding the six-month benchmark. For cancer drugs, this delay extends to over seven and a half months.
**WTN:** This raises serious concerns for patients, particularly those with life-threatening conditions like cancer. Can you give us specific examples?
**BM:** Sadly, we have numerous examples. A lymphoma treatment submitted in September 2022 faced a 177-day wait for its preliminary questions. Another cancer drug, intended for patients unable to undergo chemotherapy, submitted in January 2023, still hadn’t received initial queries by November 20th – a staggering 279-day delay. These delays, compounding across different stages of the process, can extend the overall wait time for patients to two years.
**WTN:** What are the implications of these delays for Irish patients compared to those in other EU countries?
**BM:** This is simply unacceptable. Other EU countries operating under the same framework consistently meet the six-month timeline. The issue isn’t restricted to Ireland alone; it’s a matter of resources, process efficiency, and accountability. The HSE lacks the necessary funding and support to meet the legal requirement, hindering access to potentially life-saving treatments for Irish patients.
**WTN:** The IPHA has put forward proposals for addressing this issue. Could you outline them?
**BM:** We’ve proposed a three-pronged approach:
1. **Increased funding:** The HSE requires adequate funding to effectively process applications within the stipulated timeframe.
2. **Process optimization:** The current drug approval process needs streamlining to enhance efficiency and accountability.
3. **Transparency and data sharing:** Implementing performance indicators and public reporting on the process would hold stakeholders accountable and drive progress. We need visibility into the delays and a dedication to resolving them.
**WTN:** Mr. Mahon, this is a crucial issue for public health in Ireland. What message would you like to impart to the incoming government?
**BM:** We urge the incoming government to prioritize reforming the drug approval process. Time is of the essence. Every day of delay represents a missed opportunity to improve the health and wellbeing of Irish patients. By taking decisive action, we can ensure that Irish patients have equitable and timely access to the latest medical innovations, just as their counterparts in other European countries.
**WTN:** Thank you for your time and insights, Mr. Mahon.
**BM:** My pleasure.
