One of the key national agencies is the Health Products Regulatory Authority (HPRA), which is tasked with regulating the vital sectors of pharmaceuticals and medical devices, ensuring the safety and efficacy of the products used here and the quality of those manufactured in Ireland for onward distribution and sale elsewhere across the world.
The HPRA is the national regulator across many different health products: medicines, particularly pharmaceuticals and biopharmaceuticals, for human and veterinary use. The agency also oversees medical devices, cosmetics, as well as licensing and supervision of handling of blood tissues and cells that are increasingly coming into use through personalised therapies and advanced medicine.
“As an agency, we’re quite unusual in the breadth of regulatory competence that we have in one organisation,” explains Grainne Power, director of compliance with the HPRA. She describes the HPRA’s role as “the objective advocate for the patient, in terms of the standards we expect from manufacturers and facilities, but also in ensuring that any findings we have are well founded and fair”.
At the core of the HPRA’s mission is its dual commitment to protecting patients while fostering an environment where companies can innovate and thrive. It achieves this balancing act through a combination of robust regulation and proactive engagement with industry.
Broad regulatory oversight
In the pharmaceutical and biopharmaceutical sector alone, the HPRA is responsible for overseeing close to 300 companies; not just their operations in Ireland but in some cases acting as the supervisory authority for some third-country sites depending on the products those companies are releasing to the market.Part of the agency’s work involves travelling the world, inspecting on behalf of the European Medicines Agency (EMA). For example, some medicines are subject to centralised authorisation by the European Commission for all 27 member states. “If a product is going to be batch-released from Ireland, the HPRA will be asked. So we can end up in Asia or in the US, in state-of-the-art biological manufacturing sites or products around the world, which means our inspectors are not just looking at Irish industry, we’re looking at global manufacturing sites which also feature highly innovative products and processes,” Power explains.
This exposure to operations in other countries allows the HPRA’s inspectors to benchmark Irish sites, and Power says that they tend to do well during inspections in comparison to facilities elsewhere. As part of the agency’s mutual recognition agreement with its United States equivalent, the FDA, the latter agency will sometimes inspect Irish sites. These Irish-based sites tend to perform well compared to their peers in other countries, Power adds.
Working relationships across borders
Close links and strong working relationships with counterparts in other countries give the Irish regulator the ability to confer with colleagues or draw upon experience from other countries. “We don’t work in isolation. We are part of a network of European inspectors who are regulating similar industries,” Power adds.The HPRA calls on many highly qualified scientific individuals and people with industry experience for its work. “We’re inspecting manufacturing sites that are often part of a complex supply chain, and a global industry and are linked into the global corporate systems. So our oversight requires teams of inspectors who understand how those companies operate, so that when we go on site, there’s a sense of knowing how these systems work,” Power says.
The HPRA’s role to act as an “advocate for the patient” takes on greater importance because of continuing advances in pharmaceuticals and medical devices. The HPRA’s combination of collaboration with rigorous oversight and a forward-thinking approach ensures that companies operating from Ireland not only comply with stringent regulations but can also innovate.
Evolving in line with industry progress
“Lots of pharmaceutical companies are seeking to continuously develop their operations here, so it’s an ambitious sector. The challenge of regulating in this environment is that there’s a need to constantly evolve our own technical expertise and understanding of what’s coming and keep pace of developments in the industry we regulate. We accept that it’s part of our job to progress and not stand still,” Power says. As part of maintaining that progress, the HPRA helps to ensure that pharmaceutical, biopharma and medical devices operations in Ireland remain at the forefront of best practice. “We’re very conscious that we have a very strong manufacturing base in Ireland and it’s very important to the country that that base is maintained and developed and moves with the developments in medicine. So we’re conscious of the need to meet the pace of that and to support that base,” Power says.
Part of this support involves providing advice to companies to help them meet their obligations, and engage with them by providing updates on the regulatory environment and sharing information about the kinds of issues that can crop up during inspections.
Proactive engagement with pharma sector
“We find the industry is engaged and hungry for that information, because it helps them to maintain their quality systems and manage risk in their organisation,” Power says. “We can’t always give the answer that everyone wants, but it’s important that we are listening, educating and engaging where possible.”That three-track approach of listening, educating and engaging was how MeiraGTx, a clinical-stage genetic medicine company, experienced its dealings with the regulator. The US-headquartered company had chosen Ireland as its manufacturing base when scaling from clinical trials to commercial production. The site in Shannon also hosts the company’s global testing laboratory. By mid-2023, MeiraGTx had been working with the regulator to secure its first regulatory licence. In reality, the engagement had begun much earlier, says the company’s site operations director Greg Simmonds.
“From day one, when our site was an empty field, we were in meetings with the HPRA, inspectors and guidance folks, and they were giving us pointers and feedback about our proposed designs before a piece of steel had even gone in the ground. That’s what you want, right? Because they don’t want someone to build the wrong factory, they don’t want someone to design something that isn’t going to work or operate in the wrong way. So there’s an ongoing dialogue with regulators to make sure we meet the needs of our patients,” says Simmonds.
In the past, it was an “organic” process that led to companies approaching the HPRA when seeking a licence to operate in Ireland. Now, as Power explains, the agency has amended its processes so that companies can’t just rely on just filling out forms to apply for licences: they need to speak with the regulator first and start a dialogue – which helps the regulator to understand the capacity of the new company, while the company benefits by saving valuable time with its application process.
The HPRA’s proactive, collaborative approach has been instrumental in Ireland’s success in establishing itself as a global leader in the life sciences industry. By ensuring that regulatory requirements are clear, consistent, and aligned with international best practices, the agency enables businesses to thrive while upholding the highest standards of safety and quality – fostering patient confidence and allowing the industry to drive progress.