In June this year, European pharmaceutical company Norgine held a 50-year anniversary for its global manufacturing site in Hengoed, Wales. Following the event, European Pharmaceutical Manufacturer editor Reece Armstrong caught up with Norgine’s CEO Peter Stein to discuss pharma trends, US and EU drug approvals and the company’s approach to improvement.
Magnifying Glass
Stein begins by explaining the roots of the Hengoed site - its 50-year history born from small beginnings with a team of around 20 employees. Now, the site is responsible for producing over 30 million packs of medicine every year, a fact recognised at the event as well as the ‘unique position Hengoed has in Wales as a major manufacturer for the world,’ according to Stein.
Norgine itself has a rich history. A family owned business founded in the early 1900s, Norgine was the first company in central Europe to start manufacturing insulin but fell dormant in World War II until it was eventually revived by Walter Stein after the war.
Norgine serves markets in the US and Japan but Stein explains that what the company has really done is build a European platform ‘that’s able to develop, register, manufacture and market products on a European scale’.
During Stein’s time in the industry, the biggest change he’s seen ‘is the extent to which the industry is much less fragmented by national markets and standards and it’s more focused on regional or global standards’. Indeed, it’s these harmonised standards – introduced by the European Commission in 2008 to help companies market products in the EU and European Economic Area - that Stein believes has enabled Norgine’s success in Europe.
Another area Stein is keen to emphasise is just how differentiated new therapies need to be if they are to really add value to patients and healthcare systems. In fact, what quickly becomes evident during our chat is just how advantageous Stein believes the EU healthcare system to be compared to that of the United States’.
Originally from the US himself, Stein’s time in Europe has really made him appreciate the European system.
“It’s a good thing that the industry is obliged to focus on products that actually add value and actually change patient care and actually deserve to be added to medical practice,” he says. This focus on ‘added-value products’ ensures companies focus their R&D effort ‘towards things that are going to make a difference,’ Stein adds.
But perhaps the major advantage for manufacturers is the immediate access they gain to the EU marketplace once they receive reimbursement. While this benefits patients through the access they get to medicines, the United States’ system of private healthcare still leads to patients being unable to afford medicines, even though they’re still technically available.
But while the EU certainly holds many benefits for both pharmaceutical manufacturers and patients, the conversation is quickly derailed by Brexit and the uncertainty it presents.
For Norgine, its priority has been in ensuring patients will always be able to access its medicines, Stein iterates.
“Continuity of supply has been first and foremost in our thinking. We’ve been preparing for it [Brexit] since 2016. Unfortunately it’s costing a lot of money, it’s costing a lot of time but I think we are in a position that we will be able to make sure our patients continue to receive our products in any scenario.”
Not wanting to get caught up in the complexities of Brexit we move on to talk about Norgine’s base in Wales and the country’s perhaps under-recognised contribution to pharma.
“I think it’s one of the things that deserves more attention. Wales is actually a fantastic place to locate a life science company. You have academic institutions that are very strong and that can form highly trained workforces,” Stein says.
That workforce, Stein adds, has helped drive Norgine through a culture that is dedicated to learning and developing.
When questioned on the potential of workers being left behind by the introduction of new technologies, Stein has absolute admiration for the way Norgine’s workforce have upskilled.
“The shop floor employee of 20, 30 years ago would not be able to cope with the technology they’re using today and almost universally people have embraced it because it is essential for the future of the site.”
Moving on, Norgine sees itself focusing on two avenues of growth which will help bolster its European base and also bring medicines over from the US into the European market. So for the UK and in particular Wales, Norgine’s success is bolstering the Welsh life sciences industry and bringing attention to an area which in Stein’s view, deserves more recognition.