This article is part of our special report The future of biotech in Europe.
The EU’s policy priorities are a once-in-a-generation change to the regulatory framework that can offer the industrial biotech and healthcare sectors an opportunity to set a direction for the next decades and become “a powerhouse for innovation”, says the newly appointed chairman of EuropaBio.
In an interview with EURACTIV, the new boss of Europe’s largest biotech association, Andrew Topen, spoke about the impact on the bioindustry sector of a number of flagship policy initiatives recently put forward by a ‘very active’ EU executive.
“We have a unique opportunity with all of these policy proposals to really become a powerhouse for innovation in the future,” he said.
He referred to several of the EU’s policy priorities, ranging from the industrial strategy to the environmental ambition in the Green Deal, not to mention the pharmaceutical strategy and the new approach on digital.
“We are working very closely with all the stakeholders to ensure that our industry’s interests are understood,” he stressed, adding that his association wants to ensure a robust regulatory framework that can actually be a catalyst for growth.
Topen mentioned a recent study published by the Wifor Insitute, where the biotech industry has been considered one of the fastest-growing innovative industries in Europe, with an average annual growth rate of 4.1% from 2008 to 2018.
“Biotech impacts everyone’s lives on a daily basis and we have in Europe all those key components to be successful,” he said.
The study depicted biotechnology as a high-value sector for employment as well, as it pointed out that for each job in life science three jobs are created elsewhere in the European economy.
However, without the right ecosystem to support such innovation, there could be problems in scaling up the potential impact of biotech along the whole value chain.
“This means that those jobs can go elsewhere. But if the general public understands more the importance of that, perhaps they would be more in favour of locating those opportunities within the EU,” he said.
For Topen, there is already a very vibrant ecosystem in Europe that should be kept supported to remain highly competitive at the global level and attract clinical trials and investments.
This ecosystem is made of strong academic clusters as well as SMEs, start-ups, and global multinational companies, all with a European focus and headquarters on the continent.
“Europe has a proud heritage of being an innovator and supporting innovative industries,” he said, adding that public support programmes like the recovery and resilience fund can act as a massive catalyst to make the system resilient and moving forward.
Another risk for the sector comes from the fact that science is continuously evolving and the regulatory framework needs to evolve in step.
Likewise, ensuring the Green Deal commitments requires that EU regulation “should reflect where we are today and where we need to be tomorrow.”
A key point on EuropaBio’s agenda is, for instance, the modernisation of the genetically modified organisms (GMOs) legislation – adopted more than 20 years ago – in a way that could include also microorganisms, which are considered by association as the backbone of biological systems manufacture.
A ‘future-proof’ approach goes hand in hand with the evolutionary process of science, according to Topen: “Innovation comes on in leaps and bounds and we obviously need a framework to get a predictable environment for investments which are often at high risk.”
Like jobs, these investments risk going elsewhere and this is why Europe needs to remain competitive in a global landscape. “It is clear that other geographies are highly competitive for the flow of capital, intellectual capacities, and they also value the biotech industry,” he warned.
Risks of fragmentation
The EuropaBio chairman also stressed that an imperfect single market with a different implementation of EU legislation at the national level can create weaknesses for the system as a whole.
“We saw in the early days of the COVID-crisis national governments acted in a very nationalistic way,” Topen said referring to national emergency policies more focused on single countries rather than the European environment
The crisis offered to the sector many learnings about these bottlenecks and their detrimental impact when it comes to the security of supply.
“We are working in an environment where supply chains are truly global and they need to be resilient,” he said.
Bottlenecks inevitably led to short term interruptions of those supplies with a downstream effect on the availability of things like medicines, but also other essential goods at the time.
The forthcoming creation of a common European data space also offers a great potential for the biotech and the single market but it also bears risks of fragmentation.
“The flip side [of a European data space] is that if you don’t get it right, then you will have 27 different approaches, making the whole thing just overly complicated and a missed opportunity.”
The COVID crisis and the vaccine race showed that both the research and the manufacturing sector are able to shorten timelines significantly by following the procedures and without cutting corners.
According to Topen, the global society managed to bring a healthcare intervention like vaccines in a short time thanks to a 24/7 approach where data across different geographies has been shared quickly and in real-time.
“We can take those learnings and apply them to other areas of non-communicable diseases, for example, using the data interoperability of healthcare systems and regulators to advance as quickly as possible,” he concluded.
[Edited by Zoran Radosavljevic]