The race is on throughout the EU as valuable agencies flee a Brexit-coloured UK. But does Ireland’s regulatory expertise stand out enough to profit?
Ireland wants more from the EU. After gaining a vastly improved road infrastructure, access to one of the most lucrative markets in the world and, lately, an immense level of debt since it joined in 1973, Ireland wants a bigger slice of the pie.
With the Health Products Regulatory Authority (HPRA) largely banging the drum, Ireland wants the European Medicines Agency (EMA) to relocate to Dublin.
Before its move from the UK (it’s currently in a state of stasis until a new location is chosen), the EMA enjoyed a close relationship with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
This meant that the MRHA held sway when rules and processes were being devised. It’s this kind of access that the HPRA wants. But why should Ireland even be considered?
It’s not for any perceived logistics perfection, as that already seems to be an onerous task to satisfy, but it might be for its regulatory expertise, according to Lorraine Nolan, chief executive of HPRA.
Tough, but fair
“I think we have a really good reputation in terms of regulations of medicines within the EU,” said Nolan, speaking to Siliconrepublic.com. “We’re viewed as open and progressive. Tough, but fair.”
Nolan’s organisation doesn’t just handle submissions for new products or services, it also enjoys a supervisory role, visiting manufacturing sites throughout Ireland, of which there are many.
She claims that one of the main reasons why Ireland has been so successful in attracting FDA in the pharmaceutical manufacturing field is “the strength of our regulatory system and the environment we provide”.
Nolan and the HPRA maintain open dialogue with companies, large and small, liaising with them throughout their development run. For example, there’s no point having a product almost at market before it falls foul of the regulatory framework at the last hurdle.
“The last thing we want is when they come to the final stage and we say the whole developing programme doesn’t meet the regulatory requirements. We can’t [have a situation where] we block it at the last stage, rather than enable it.”
With close to two decades of regulatory experience, Nolan has seen a lot of change in the industry, especially as the internet of things shift brings more and more connected devices into the healthcare industry.
She said the dialogue has progressed significantly towards innovation in recent years, something that has forced regulatory bodies to invest significantly in order to keep up.
And what are they keeping up with? Convergence.
All about healthcare
There are always new areas of medicine, with Nolan noting spaces such as stem cells, complex manufacturing processes, disease and clinical design challenges as just some of today’s main topics.
For developments in these spaces, convergence is key.
“With convergence, you can be talking about a medicine, a medical device and an ICT application, combined.
“Regulating these products is becoming more challenging. We are ageing, living longer. Long lives lead to greater complexity.
“There’s a huge push for new and novel treatments. We’re also dealing with much more informed patients. They expect the best and most innovative treatments available.
“We’re dealing with highly performing industries: pharma and medtech. Their survival is based around the ‘pipeline’. As more competition comes in, generics enter. Innovative agencies only survive by innovation.
“From a regulatory standpoint, we are going through very exciting developments.”
It’s good to talk
Of note in this area is a reputational strength to withstand scrutiny from beyond Irish borders, and beyond EU borders, too.
Dialogue with global regulators is a constant requirement, something the HPRA – largely through initiatives such as the International Coalition of Medicines Regulatory Authorities – plays its part in.
“When you look at different regulatory frameworks and jurisdictions, global harmonisation is difficult to achieve.
“With the FDA in the US, or Japanese and other Asian regulators, bilateral interaction is hugely important.
“We’re really focusing on areas of risk. If we know the FDA are working to high standards, and if there is a mutual recognition process in place, we should not waste resources retesting, reinvestigating.”
On the road towards a more harmonised regulatory process, Nolan thinks Ireland is a good fit for the EMA.
As for the average Joe and Josephine, it seems that no matter where the agency ends up, medical developments are ticking over nicely. And, considering regulatory bodies are self-funded, it’s not costing us a penny.