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Europe accounts for approximately 12% of the global biotech market, and it has an ambition to expand that footprint. On 9 April 2025, the Centre for Future Generations, together with Euractiv, organised a roundtable discussion to look at the security of Europe’s biotech future.
Biosecurity is often viewed in the context of risk management and regulation, but it can be overlooked that it also plays an important role in innovation, market leadership, and competitiveness. While biotechnology involves using biological systems, organisms, or their components to develop products and solutions across industries such as healthcare, agriculture, and manufacturing, Europe’s approach to biosecurity can affect trust in biotech products, including their attractiveness to investors.
Policymakers and industry stakeholders continue to consider balancing biosecurity measures and innovation. At the same time, Europe’s role in shaping global biosecurity standards—the so-called Brussels Effect—is seen as valuable in terms of broader economic and security strategy.
Innovate, safely
Irene Sacristán Sánchez, Head of the Biotechnology Unit within DG SANTE in the European Commission is primarily responsible for the legal framework on GMOs and the legal proposal on New Genomic Techniques (NGTs). She is also involved now in the preparatory work on the Biotech Act. “I come at this from a role where it’s my responsibility to ensure that we have a regulatory framework that ensures the safety of human and animal health and the environment while enabling innovation,” she explained.
Sánchez looked at biosecurity from two different perspectives: “First, if you think of biosecurity in the broad sense of the actions to protect plant, human, animal health and ecosystems, biotechnology can be a contributor to biosecurity. Not just in terms of competitiveness or resilience of our supply chains, but also very directly to biosecurity through, for example, plants that can withstand pests or diseases.”
“Of course, when we speak of powerful and transformative technologies, there is always a safety angle. We need to have measures to deal with unintended or intentional risks. And in that regard, we have in the European Union a very, very strong bio-safety framework,” she added.
Sánchez remarked that “We pay a lot of attention to the products of biotech and other innovations to ensure their safety. And I would say that that’s a strength of our system. I would also say that this element contributes to competitiveness.”
Safety, but competitiveness too
MEP Tomislav Sokol is the coordinator of the European People’s Party in the SANT Committee in the European Parliament and looked at biotech in health, including patient safety.
“When you speak about new health technology, medicines, medical devices, etc., these new technologies must be developed in a way which guarantees safety for the patients. So, we have that on one side and on the other side we have competitiveness,” he said.
“It’s often presented as a kind of dichotomy, meaning that the more safety standards, the less competitiveness. Of course, if you put this into a global context, we see it with US President Donald Trump, who obviously wants us to get rid of all of our safety standards, which are higher than the American ones, because he thinks that this acts as an impediment to trade.”
“Obviously, this is something that will be a big topic in the months and years to come. But I think that our standards of safety are our strength and that we absolutely should not go below what we have now,” said Sokol.
However, he added that there are other ways we can increase competitiveness.
“For instance, there is a lot of bureaucracy, red tape, and unnecessary steps that we could shorten, without jeopardising safety. For example, in medical device regulations, why do we recertify low-risk medical devices, which have been on the market for decades, every five years? I think we can also increase competitiveness in the areas of public procurement, faster permitting for building new factories, intellectual property protection and market exclusivity.”
“So, there are a lot of different aspects where the EU can definitely improve competitiveness without jeopardising the safety of medicines and biotech. I think that’s what we should really focus on. Any kind of decrease in terms of safety standards is a no-go for me, and also, I think for a big majority of the European Parliament,” he said.
Strict regulations
Jeroen Groenewegen-Lau, Head of Program Science, Technology and Innovation, Mercator Institute for China Studies (MERICS), explained that he looks at the Chinese debate on security.
“Here, we actually have an example of a very successful, innovative country that also has a very strict regulatory regime,” Groenewegen-Lau explained.
“China is very active in streamlining some of the permit systems and approvals, and integration of that whole national market. So all of that is much smoother. They use their procurement system to great advantage,” he said.
“I think they’re also doing a few things that we would not want to copy, per se, and that are also detrimental to some foreign companies active in the Chinese market. But in this realm of global geopolitical competition, I think it would be good to look at how it’s structured, at least. On the front of technology transfer and market access, do we see other countries developing really good biotechnology sectors?”
“Maybe we want these companies to be active on the European market. So, how do we organise that so that they’re willing to come and that we can benefit from some of that technology? I think those are some of the areas we could look at,” said Groenewegen-Lau.
Biotechnology enabling biosecurity
Claire Skentelbery, Director General of EuropaBio, pointed out that biosecurity is a pretty broad scope!
“Fortunately, EuropaBio is a very cross-sectoral association, so we look at biotechnology from all angles. When I’m thinking about biosecurity, I’m thinking about the role that biotechnology plays in enabling biosecurity. Because this is a global thing. We need to preserve and protect food supply chains,” said Skentelbery.
“We need to protect human health; we need to protect environmental integrity. And all of that requires an understanding of what you are trying to address. So, if you’re looking at pathogen spread due to a changing climate, for example, you need to be able to understand what those pathogens are, how you monitor them, how you track their progress towards you, and how you mitigate these. For me, these are all incredibly important cross-cutting elements of biosecurity,” she said.
Skentelbery added that intellectual leadership, capacity and partnerships are essential “because nothing happens in biosecurity at a national level, it must happen globally.”
“We’ve had such amazing breakthroughs in our ability to use biotech as both a tool for understanding, but as a tool to prevent and manage and mitigate as well. And so for me, biosecurity and competitiveness are the same thing.”
“You know, you look at the innovations in terms of vaccine development, sort of in terms of remote diagnostics, in terms of early treatment, all of these things are competitiveness options, and they are done within the really excellent safety standards that Europe has set as the highest standards globally.”
“We’ve had such amazing breakthroughs in our ability to use biotech as a tool for understanding, but also as a tool to prevent, manage and mitigate risk as well. So for me, biosecurity and competitiveness are the same thing.”
“Look at the innovations in terms of vaccine development, of remote diagnostics, of early treatment, all of these things are competitiveness advantages, and they are done within the really excellent safety standards that Europe has set as the highest standards globally,” she said.
AI designed pathogens
Velislava Petrova, Chief Program Officer at the Centre for Future Generations, explained how AI is supercharging biotech, accelerating discovery, but also introducing risks, such as AI-designed pathogens and automated, unregulated labs.
“Biosecurity is changing its definition with the arrival of AI, and that’s one aspect that we’re really looking at. AI is rewriting the script of what we can do in biotechnology. It’s no longer biotechnology in a lab or a research facility. It’s in areas where people can have direct access to technologies in ways that, before, perhaps were a lot more confined. So, we want to look at what biosecurity is in the current context,” she said.
“Biosecurity today means anticipating emerging risks and embedding safety into innovation from the start, not regulating after the fact. That’s the first aspect that we had in mind at the Center for Future Generations. European policy should not be reactive but must have safety in mind without compromising competitiveness or innovation.”
“Our approach at the EU level should not be that we wait for technology to emerge somewhere else, and then we come and regulate it. We should really invest in this tech. We need to make sure it’s embedded in new principles and values. So, we should invest in safe tech, invest in countermeasures, and also come up with regulations.”
“For us, it is really about thinking that it’s not a contrast between regulation and innovation, and it’s actually through the path of investing in safe tech that we can reach that competitiveness,” concluded Petrova.
This article follows the policy debate “” supported by CFG.
[Edited By Brian Maguire | Euractiv’s Advocacy Lab ]
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