Dublin – Ireland’s pharmaceutical sector, long hailed as a cornerstone of the country’s economic success, is facing a critical juncture. Despite a world-class manufacturing footprint and a global reputation for excellence, the country is struggling to ensure timely access to innovative new medicines for patients.
At the heart of this paradox is a disconnect between investment and patient benefit – a gap that industry leaders say must be urgently addressed.
“Right now, from an Irish perspective, our number one priority is access,” said Eimear O’Leary, Director of Communications and Advocacy at the Irish Pharmaceutical Healthcare Association (IPHA), speaking with Euractiv in the heart of Dublin’s tech hub.
“Patients in Ireland access new medicines later here than those in most other Western European countries due to our slow reimbursement process. The system needs to be reformed to ensure that patients do not continue to wait to access life-enhancing medicines.”
The issue, she argues, is not just about healthcare – it’s about Ireland’s competitiveness in a shifting global landscape. “If you’re a company investing in Ireland, and those medicines are not available to patients in Ireland, that is a problem,” she warns. “Particularly now, given the threat of tariffs and the drive for industry to reshore back to the US, which are both in question.”
A slow path to access
The Irish government has committed to improving access, but progress has been sluggish. “There has been a commitment in the programme for government to make medicines available to patients as quickly as possible,” notes O’Leary. “We have seen public statements from leading politicians that they’ve recognised that the process is slow here.”
While the hiring of 34 new staff members to accelerate the reimbursement process is welcome, the impact to date has been negligible. “We don’t believe that has necessarily had an impact,” she says. “Our research would find that it continues to take two years, on average, for a new medicine to be made available. That’s two years that patients don’t have.”
The 2013 Health Act mandates that medicines should be made available within 180 days, including clock stops. “We’re asking for the government to implement that,” she said. “We would maintain that by adhering to the law, we can make medicines available about a year faster.”
Ireland is not alone in its delays, but it lags its European peers. “Germany does it very well, top of the class, as does Austria,” she remarked. “I don’t think any system has it completely right either, but what I do know is that Ireland is particularly slow.”
The consequences are not just medical – they are economic. “The commercial environment, including faster access, has to be recognised as a factor when looking inwards to Ireland for investment decisions,” she insists.
A strategy still in waiting
Ireland’s lack of a coherent life sciences strategy is another source of concern. “We don’t have one,” she says bluntly. “There was a commitment in the programme for the government to implement a life sciences strategy, which we hope to see in 2026 with a public consultation opening later this year.”
The strategy, to be led by the Department of Enterprise, must go beyond infrastructure and investment, she said, “It has to include the wealth and the health of the nation, incorporating everything from bench to bedside. Driving R&D in Ireland, bringing more clinical trials to patients in Ireland, and right through to that access piece.”
A National Clinical Trials Oversight Group has been established and is currently presenting recommendations to the government. But O’Leary stresses that this is only one part of the puzzle. “We have to connect that with the health and with the access part as well.”
She points to Ireland’s “innovation paradox”: a country that excels in pharmaceutical manufacturing but fails to deliver those innovations to its own population, though O’Leary acknowledges that “A lot of it will come down to budget cost.”
Despite almost €160 million invested in new medicines over recent budgets, some through efficiency savings, the process remains pedestrian, “That [extra funding] hasn’t quickened up the process either,” she says. “And there’s now new staff being employed, but that hasn’t helped at all.”
EU Pharma Package, global competition
The EU’s pharmaceutical legislation has been a battleground for maintaining Europe’s competitiveness. “The big win was maintaining the status quo in terms of the regulation of data protection at eight years,” she says. “If there had been a decrease to six years… it would have impacted the competitive nature of Europe.”
She adds: “25 years ago, Europe was leading the way in terms of R&D. We have fallen well behind.”
Ireland’s decision to support the status quo was critical. “That was a very important position for Ireland to take in terms of future investment in Ireland and creating that certainty which the market needs.”
The future of pharma
The future of healthcare, O’Leary argues, lies in prevention, and pharma must play a central role. Yet even in vaccines, Ireland is slow. “We’re … exceptionally slow at making vaccines available,” she says.
Antimicrobial resistance and AI-driven diagnostics are also reshaping the landscape. “There are AI capabilities that will change how we diagnose and treat patients that we need to embrace, she says. “There’s incredible research being done here in Trinity on preeclampsia in pregnant women, for example.”
Despite being the data centre of Europe, Ireland lacks a digital health infrastructure. “We do not have a digital health records system in Ireland yet,” O’Leary says. “An Irish person cannot access their medical records online.”
The implications are profound. “That impacts everything in terms of R&D. That impacts clinical trials as it causes difficulties in finding patient populations.”
She offers a stark example: “If you go to a hospital in Galway… and six months later, you have to go to a hospital in Cork, or Dublin. There is no record of that happening.”
Even supermarkets, she notes, have better data systems. “You can have your fob on your key, you know, tracking your spending habits, but there’s no record of your health?”
The recently passed Health Information Bill and a new HSE health app are steps in the right direction. “All my vaccination records are there,” she says. “But it’s going to take years.”
Oversight and coordination
When asked ‘What’s missing in government,’ O’Leary says, “There does need to be somebody within, preferably the Department of the Taoiseach, who has oversight over the life science sector to ensure policy coherence across Departments.” The big political vision, she explains, is critical.
Speaking with O’Leary, it’s clear that Ireland is gradually aligning its health, innovation, and investment strategies, nudged by the realisation that if it fails to do so, it risks falling behind – a scenario that Ireland cannot afford.
This interview has been edited for brevity.
By Brian Maguire