European Union lawmakers are being urged to avoid too much risk aversion from holding back the potential of the homegrown biotech sector.
Developments in biotech could be transformative in a range of critical sectors. Beyond huge promise in healthcare, innovative, low carbon applications in areas like agriculture and food systems and energy production could help address pressing environmental and sustainability challenges. But there’s concern among some local operators that the bloc’s current approach could cap potential biotech benefits — especially in the context of the urgency required to tackle the climate crisis.
“The main regulatory challenges for the EU’s biotech startups are long timelines for approval of new products and a lack of openness towards modern biotech solutions that may lead to GMO solutions,” Joško Bobanović, partner at Sofinnova Partners, a major investor in European biotech, tells TechCrunch. “Today, EU startups often do not bother trying to get approval in Europe because of long approval timelines, opting instead to go directly to the US or Asia. This is a huge loss for Europe given the plethora of leading-edge technologies developed here.
“Recent Nobel prizes for technologies like CRISPR or for discoveries that led to RNA vaccines highlight European regulators’ hesitance toward genetic technologies, similar to favoring landlines over mobile phones. (Remember what happened with Nokia and smart phones.) The potential benefits of these innovations far outweigh the risks even as they are part of a duly rigorous regulatory cycle.”
“If you look at venture capital, there’s significantly more money going into the synbio [synthetic biology] community in the United States, and so we’re really at a disadvantage here in Europe,” says Stef van Grieken, CEO and co-founder of EU-based startup Cradle, which offers generative AI tools to help bioengineers design proteins. “There’s also a lot of regulatory risk in Europe. So GMO, a lot of these types of techniques are considered genetic modification. And rules in Europe are very strict. And so if you look at a company like Meatable, that’s growing meat in in a dish instead of using a cow — they’re a Dutch company but they’re launching their products in Singapore, in the United States due to regulatory constraints.”
He also points the level of recent biotech support announced by the Biden administration, including a pledge to invest $2 billion in biotechnology and biotech manufacturing — suggesting the bloc is lagging behind on financial support for the field too. “According to McKinsey, about 60% of our current economic inputs you could make with biology,” he says. “And so that’s substantial, right? Like everything that we consume is a lot larger than the things on the internet.”
“One of the things that’s starting to become obvious is there’s lots of application domains for these types of techniques,” he adds, discussing generative AI’s role in accelerating biotech R&D. “I mean, I’m excited about ChatGPT and [popular generative AI] applications but let’s say… [helping] science and R&D teams to get their bio-based products to market faster to help us solve climate change may be a bit more important than producing better marketing copy.”
Earlier this month the European Union adopted a list of ten technologies it considers critical to the bloc’s future economic security — ranging from AI, quantum and advanced semiconductors, to space tech, robotics and biotech — making a clear statement of recognition of transformative and strategic potential. At the same time, four of the listed techs were flagged for further risk assessment, including biotech (the other three pegged for extra scrutiny are: AI, advanced semiconductors and quantum).
The Commission’s recommendation suggested Member States conduct collective risk assessments of these four critical areas by the end of the year — with lawmakers highlighting the possibility that transformative potential could also lead to highly sensitive risks, such as threats to fundamental rights or civil-military fusion.
Reports have suggested the move could prefigure the introduction of additional EU regulations.
Of the four technologies flagged for risk assessments, biotech may be the least familiar, in terms of public understanding — with the term spanning practices like genetic modification; new genomic techniques (such as CRISPR-Cas9 gene editing); gene-drive; and synthetic biology (aka synbio; a multidisciplinary field); all of which were explicitly name-checked in the Commission’s PR as examples of biotech that should be risk assessed by Member States.
The listed techs all deal with manipulating genetic material but can involve different approaches and applications. Developments in one field may also dial up potential elsewhere — such as gene editing techniques increasing potential applications for synthetic biology, for example — further advancing the complexity of developments since there may be overlap in how these biotechnologies are applied.
Despite relatively low public awareness of biotech advances, Cradle’s van Grieken points out some techniques have actually been widely used in industrial processes for years — helping to produce things like detergents which can work at lower temperatures (via industrially produced enzymes); or synthetic insulin for diabetics (i.e. instead of extracting biological insulin from the pancreatic glands of slaughtered cows and pigs).
While, as noted above, a newer wave of alternative protein startups — including companies being built in Europe — are leveraging developments in the field to do things like scale lab-grown meat or produce non-animal derived dairy proteins, on a mission to transform food systems without the huge carbon footprints attached to traditional (animal-derived) meat and dairy.
But it’s interesting how under the radar some of these regional applications of biotech remain. Certain terminology may be preferred (or avoided) in marketing copy — likely with an eye on regulatory risk and/or consumer trust.
“Precision fermentation is not synthetic biology per se,” a spokesperson for one alt protein startup — France’s Bon Vivant — told us, when we asked what it meant by “precision fermentation”, the term it prefers for explaining its dairy-targeting biotech, querying the bio techniques it’s applying to repurpose yeast microorganisms to brew up cow’s milk proteins.
“As a board member of Food Fermentation Europe, Bon Vivant is still working on a science based and still easily understandable definition,” the spokesman also responded to our ask. Its marketing copy, meanwhile, studiously avoids saying it’s genetically modifying yeast to produce milk proteins — which is essentially what it’s doing — the closest it comes is writing that it “programs” yeasts.
Yet it’s widely accepted that precision fermentation is an example of synthetic biology. (See, for e.g., Wikipedia’s definition: “Precision fermentation is an approach to manufacturing specific functional products which intends to minimise the production of unwanted by-products through the application of synthetic biology, particularly by generating synthetic ‘cell factories’ with engineered genomes and metabolic pathways optimised to produce the desired compounds as efficiently as possible with the available resources.”) So it’s curious to observe a European startup that’s doing interesting things with synthetic biology being so reluctant to say so.
The example speaks to the uncertainty steeping biotech developments in Europe — suggesting disruptors remain worried that causing a splash here could amp up their regulatory risk and bring fresh limits on their fledgling businesses, or at least trigger a new wave of consumer concern, rather than inviting admiration and unlocking homegrown support (or even — dare we say it — congratulatory cheerleading).
Cautionary tale
Cradle’s van Grieken is concerned the EU taking an overly risk averse approach to biotech is out-of-date with where the bloc needs to get to; that precautionary treatment of biotech is riskily self-defeating when it comes to the challenges now facing the bloc, including its headline green ambition to get to ‘Net Zero’ by 2050.
Europe is already “late to the party” when it comes to recognizing the economic and strategic importance of biotech compared to the US and parts of Asia, he argues. But his worry about the EU’s modus operandi is an active frustration that the bloc may be creating a blindspot by not being more encouraging of a sector with transformative potential when it comes to tackling the existential crisis of climate change.
“[Synbio’s potential] is not actually being recognised in the environmental policies of the EU,” he suggests. “If you look at the European Green Deal, a lot of it is focused on energy — like energy production, insulating more homes; it’s focused on recycling; on reducing pollution — like mobility; those types of things. Synbio isn’t really a theme. But it could be an incredibly powerful resource for the EU.
“This specific [Commission] call to the Member States to figure out what the risks are [for biotech] — my worry is that we’ll see increased regulation in this space without actually trying to promote the space and become… a leader in this space. Which we currently, unfortunately, are not. So that’s my biggest worry. But I do think at least recognising that it is something that could be strategic, it’s a good first step.”
“Biotech is a serious business and we need serious regulation here,” he adds when pressed to confirm his position. “But inversely, we don’t want to hamper innovation based on outdated notions of what this technology can and cannot do.”
“The EU needs to accelerate its regulatory processes and be more receptive to new technologies,” agrees Sofinnova’s Bobanović. “This is a critical success factor in the global race to address climate change but also to ensure food independence, a topic becoming more prominent post–COVID-19.”
“Failing to adapt may see our innovations benefiting other markets and the EU losing its competitive edge, much like the electronics industry. Once we lose talent and knowledge centers, it is impossible to recover them,” the investor also warns.
Consumer concern about genetically modified organisms (GMOs) does have a long history in the EU — especially in relation to food safety — which likely informs the precautionary approach the bloc has adopted towards the use of biotech in food production since at least the early 2000s. Out of that has come a legal framework that’s focused on health and safety; harmonized risk assessments; labelling; and traceability.
Consumer awareness of cutting edge biotech may be low but a perception of public concern over GMOs in food, which took root after an earlier era of developments during a time of more lax regulation, has been harder to shift. Yet actual consumer concerns are concentrated elsewhere, research suggests.
A 2019 Eurobarometer survey on food safety indicates EU citizens’ concern over GMO has declined while worries about food risks associated with traditional farming methods are riding high. So while 44% of respondents (the largest proportion) said they were concerned about the presence of antibiotics and hormone residues in meat; and 39% were worried about pesticide residues in foods; a lower proportion — 27% — said they were concerned about GMO being used in foods and only 4% were concerned about genome editing in this context (albeit, for the latter bio technique, the survey also found relatively low knowledge of the use of genome editing in food production — 21% vs 60% for GMO in food — so very low concern there may be a reflection of low awareness).
The survey results suggest EU policymaking in this area — certainly on the food front — risks being out of step with public safety concerns. (To wit: Environmental pollutants in fish, meat and dairy was another big worry for 37% of respondents.)
Taken together the Eurobarometer paints a picture of regional consumers with substantial anxieties about the health risks (and environmental toll) attached to current farming and agricultural practices — and lower concern about biotech being applied to engineer food output. (Also relevant: A Eurobarometer survey from 2021 which found an overwhelming percentage of EU citizens consider climate change to be the most serious problem facing the world.)
Yet the bloc remains saddled with a regulatory regime that ploughs massive subsidies into traditional agriculture while demanding high levels of caution — and even throwing up regulatory hurdles — when it comes to applying biotech to critical sustainability challenges. Critics argue this combo looks increasingly misaligned with where the bloc says it wants to get to with its flagship green transition.
Of course it’s worth noting that policymaking across the 27-Member State bloc is complex, with many entities necessarily involved in change-making. The Commission’s role, while important as a proposer of new pan-EU laws (and/or legislative reforms), is just part of the picture. EU Member States themselves can also have their own biotech and bio-ethics rules and reforms — so a Commission intervention listing biotech as a critical tech, and pushing for Member States to conduct risk assessments, may be aimed at driving for harmonization between this patchwork of national laws — which could, ultimately, streamline and simplify life for biotech entrepreneurs down the line.
Other factors also play a role. Another notable development for regulation of novel biotechs in the EU occurred, in 2018, when the Court of Justice (CJEU) ruled that organisms produced using relatively new techniques, such as gene editing, should fall under the bloc’s existing rules on GMO. So the legal system is also involved in interpreting how existing rules apply to biotech developments. But, again, it’s up to policymakers to keep up with such developments and make sure legislative frameworks are providing the right incentives.
“Europe is complex in terms of regulation, market access,” says Sofinnova partner Cedric Moreau, who is focused on the pharmaceuticals side of biotech investing. “We are not as the US [where] when you have the go from the FDA you have a more than a 300 million people market opening and very homogeneous.”
“We see where the European Commission wants to go — making sure that [it’s] not overlapping with State Members’ policy and making sure that the definition, and the category and the activity are very well defined; to not prevent any innovation or [developments] in the space that could be impacted by [divergence in Member State laws],” he suggests.
“It’s important to make some clear rules, clear definitions because [as investors] we need clarity,” he also tells us. “When we are investing in companies for five, eight, 10 years we cannot bet on regulation that will decide if our drug is a high unmet medical need or just an unmet medical need [for example]… And if our market exclusivity will be 10 years, or six years or nine years or five years. So we need to have clarity — and if it’s not clear enough what we will have to do to build our business case is always to retain the more conservative scenario.”
“At Sofinnova, we are a strong believer of Europe,” Moreau adds. “Because we are deploying — roughly 80% — of our capital in Europe. So we think that Europe is a fantastic playground for healthcare, for innovation. Because we have great science, great scientists, great people. And we have also an ecosystem that could really develop great success stor[ies]… Great products, impactful products for the patient. Then having said that… obviously, we think that there were several things that could be improved.”
Climate urgency vs legal uncertainty
“There is some urgency to consider these types of techniques seriously,” argues van Grieken, talking up the potential of synbio to help in the fight against climate change. “I’m not trying to advocate for ‘no regulation’ type of space. I think we need very strong controls. But on the actual end product, not on how they get researched and developed. And in certain cases, like for example with lab-grown meat or if you look at companies that are making alternatives to cheese or milk, those should be products that we should at least consider having on the market in the EU.”
“Take a company like Perfect Day foods in the United States,” he continues. “They’re making milk without cows. They can do that at, like around — I think — it’s 3% to 5% of the emissions compared to using a cow. That’s a pretty significant improvement. And we use a lot of dairy products, right? And we have a planet on fire.”
As we reported last year, Cradle is using generative AI to predict protein sequences to speed up R&D for protein engineers building bio-based products. So its business is applying AI to accelerate biotech developments — which, of course, means it has an interest in speeding up biotech progress by encouraging a more R&D-friendly regulatory environment, too.
The acceleration its customers are seeing is considerable, as van Grieken tells it — turning what would “typically” be a 1%-5% success rate for stabilizing a protein into a 50% success rate on average, thanks to the predictive power of its generative AI models. But stringent regulation is one brake the startup’s tech can’t uplift. Hence his call for EU lawmakers to zoom out and consider a bigger risk picture.
One idea he welcomes is if the EU were to establish more regulatory sandboxes where biotech R&D could be undertaken without so much legal uncertainty fogging the ambition — which amounts to a call for rules that focus more on outputs, than on the R&D itself.
When it comes to AI, a network of regulatory sandboxes is something the bloc is in the process of setting up — at the same time as EU co-legislators are hammering out a comprehensive, risk-based framework for applying artificial intelligence. So support for, and controls on, cutting edge techs are both possible under the regional lawmakers’ playbook.
Add to that, earlier this year (in April) the Commission put out out a proposal for reforming the bloc’s pharmaceutical regulation — which floats launching a regulatory sandbox as one of the suggested measures to boost regional innovation in drug research and design.
But, in that case, the sandbox would be limited to products regulated as medicines. So even if the bloc’s co-legislators adopt the proposal there are many other biotech innovations that won’t be granted a safe space to experiment — since the end product they’re aiming to disrupt isn’t a pharmaceutical. (And of course climate change won’t be fixed by popping a pill, personalized or otherwise.)
Supporting the production of edible proteins without the climate-heating emissions of traditional agriculture is just one example of biotech’s transformative potential for the environment. Bioplastics offer an alternative to petrochemical-based plastics, as another. While bioremediation is a field that offers promise for cleaning up pollutants — including by engineering microorganisms (such as algae) to accelerate uptake of CO2, the major climate heating gas.
Also on a climate tip, production of biofuels could be more sustainably scaled up using biotech techniques — such as, again, by designing microorganisms that can more efficiently turn biomass into low carbon biofuels.
European bioengineers are even working on genetically modifying plants to amp up their ability to fight indoor pollution (see: French startup Neoplants). So when you start to really think about engineering biology for human and environmental utility the canvas looks broad indeed.
Or, well, it should — but European biotech startups have to do their bluesky thinking from under a more legally clouded horizon.
For biotech startups operating in the EU, van Grieken argues it’s “significantly harder” to do the R&D and test potential innovations with so much regulatory risk hanging over the field. “There’s a lot of uncertainty,” he emphasizes. “For example, the Netherlands just introduced the ability to sample these types of [biotech-derived food] products and have investors taste them. But a very reasonable question from these investors is can you do that and sell this stuff? And if the answer is silence, then, you know, that is not a great answer. And I think this industry needs some clarity around that.”
Current EU rules also create some “weird” scenarios, as he tells it. For example, making an “informed edit” to a genome (i.e. where a bioengineer thinks about what mutation to make) would “typically” be considered a GMO in Europe (meaning the regulatory framework starts to apply) — whereas practices which produce random mutations, as happens a lot in the plant seed space, would not. So an operator that’s, for instance, shining UV light on a plant seed and introducing random mutations falls under less regulatory risk than someone doing bioengineering to select for a specific mutation — perhaps seeking higher crop yield to boost productivity or resistance to drought — regardless of the motivations behind the intent.
“If you think about how you might actually engineer one of these systems, it’s considered problematic; but if you just do it randomly, it’s fine. And so that’s not very smart,” he argues. “Because a lot of the techniques that we have today to make informed decisions about where to make changes in order to get to a certain outcome, that’s also a safe outcome — so it’s actually a lot better than doing it random.”
“If you look at, for example, the United States or places in Asia where a lot of these synthetic biology techniques are allowed it’s not like we’re seeing any major problems,” van Grieken also points out. “So we might be being a bit too constrained right now.
“You should be able to show that your product is good; actually is improving its environmental footprint; is safe to use; is delicious, in the case to food, right — and all these types of things — and get approval for it in some reasonable amount of time so you can still get to market.”
Towards a balanced approach?
Despite criticism that it’s too cautious, EU lawmakers have been talking about evolving the bloc’s approach to biotech. They have also been taking some action too.
This summer, for example, the Commission adopted a proposal for a new regulation on plants produced by certain new genomic techniques (NGTs) which would allow plants produced in this way which could also occur naturally (or via conventional breeding) to be placed on the market — exempting them from requirements in the current GMO legislation.
The NGTs the Commission has proposed loosening the rules for are targeted mutagenesis (aka plants that contain genetic material from the same plant); and cisgenesis, including intragenesis (i.e. plants that contain genetic material from crossable plants) — which would only need to undergo a verification process, under the proposal. Whereas transgenic plants (containing genetic material from non-crossable species) would remain subject to comprehensive, case-by-case risk assessment, approval and authorization prior to any sale under the EU’s existing GMO Directive.
The bloc’s Farm to Fork Strategy, meanwhile — part of the aforementioned European Green Deal which is focused on driving sustainability of agriculture and food production — recognizes biotech as having potential to contribute to the fight against climate change. “New innovative techniques, including biotechnology and the development of bio-based products, may play a role in increasing sustainability, provided they are safe for consumers and the environment while bringing benefits for society as a whole. They can also accelerate the process of reducing dependency on pesticides,” the Commission wrote in the May 2020 strategy document.
Although, subsequent to that, a 2021 study the EU undertook of new genomic techniques noted the “rapid” development of NGTs and their products over the past two decades — finding “considerable interest” in conducting research on NGTs in the EU. But it also identified that “most” development is taking place outside the EU. Which does support the contention the bloc is lagging when it comes to biotech research, despite “considerable” homegrown appetite to do this cutting-edge work.
“Following the [2018 GMO] ruling of the [CJEU], there have been reports of negative impacts on public and private research on new genomic techniques in the EU due to the current regulatory framework,” the EU’s executive also noted in the study. “Regulatory barriers would particularly affect small and medium-sized enterprises (SMEs) and smallscale operators seeking to gain market access with new genomic techniques, even though many Member States and stakeholders see opportunities for them in this sector.”
“The use of NGTs raises ethical concerns but so does missing opportunities as a result of not using them,” it went on, essentially echoing van Grieken’s point. “Based on the findings of the study, most of the ethical concerns raised relate to how these techniques are used, rather than the techniques themselves.”
At that time, the Commission concluded that any further policy action in the area should be “aimed at reaping benefits from innovation while addressing concerns”, further stipulating that a “purely safety-based risk assessment may not be enough to promote sustainability and contribute to the objectives of the European Green Deal and in particular the ‘Farm to Fork’ and biodiversity strategies”. The document also explicitly recognized that risk assessment alone could lead to a flawed evaluation process — in which “benefits contributing to sustainability” are not properly considered.
Asked about the critique it’s over-indexing on risk, when it comes to biotech, and not properly weighting potential sustainability (or, indeed, other) benefits, a Commission spokesperson declined to provide comment. But they pointed us to an EU webpage on R&D and the “bioeconomy” — where the EU’s executive also talks up the transformative potential of homegrown biotech developments, writing for example that: “Stronger development of the bioeconomy will help the EU accelerate progress towards a circular and low-carbon economy. It will help modernise and strengthen the EU industrial base, creating new value chains and greener, more cost-effective industrial processes, while protecting biodiversity and the environment.”
The page also links to the bloc’s long-standing bioeconomy strategy — which features an action plan that lists carrying out an analysis of “enablers and bottlenecks for the deployment of biobased innovations” as one of 14 “concrete actions” regional lawmakers are committed to (on paper at least).
The EU bioeconomy strategy was originally set out back in 2012, and reviewed in 2018, with the aim of supporting 2030 Sustainable Development Goals; the Paris Agreement climate objectives; and new EU policy priorities — with the Commission writing then that reaping the “economic, social and environmental benefits of the bioeconomy, dedicated bioeconomy strategies, investments and innovation are required at all levels in the EU”. Hence the updated strategy emphasizing the need for the development of national and regional bioeconomy strategies.
Five years on from that, the Commission lists just nine Member States that have set out a national bioeconomy strategy (Austria, Finland, France, Germany, Ireland, Italy, Latvia, the Netherlands and Spain) — meaning a substantial majority of EU members still lack this piece of the biotech ecosystem support puzzle. So, clearly, there’s more work for regional lawmakers to do to match the bloc’s ambition to build up Europe’s biotech base with actions that deliver results.
Looking ahead, Cradle’s van Grieken sees two big ares of promise for biotech: Human health being the first one; and what he refers to as “planetary health” as the second. “The reason why I left Google is because those are two of the major problems that my generation faces in the world,” he tells TechCrunch. “In human health, increasingly I think we’ll be a lot better at targeting disease with these types of [bioengineered] molecules and curing people.
“On the planetary health side, I think what will increasingly see is that bio-based products will come out that are cheaper than the petrochemical or animal alternatives. Because, ultimately, biology can do a lot of these things in a much lower energy way and also environmental footprint. I think we’re going to see a breadth of products that is going to be super exciting.”
He’s also bullish on cost — suggesting developments in generative AI can be the flywheel that speeds up biotech R&D — and that acceleration of developments in the lab will draw down the costs entailed in unlocking the big, transformative biotech benefits.
“It’s also why we started Cradle — to really accelerate R&D and make R&D a lot cheaper,” he says, arguing: “There is no fundamental reason why this cannot be done… Biology is ultimately capable of doing very complicated things at very low energy — like, look around you right now. There’s probably a plant somewhere there and try to realise that it’s just like water and ambient carbon that created that, right? It’s just wild, if you think about it.”
French startup Bon Vivant, meanwhile, is working to build a European business that can help tackle the planetary health challenge head on. As noted above, it’s reprogramming yeast microorganisms to produce milk proteins to offer the food industry an alternative so they can sell non-animal-based dairy products — which could have a massive impact on shrinking CO2 emissions if taken up at scale.
Foods derived from animals, including dairy, are generally associated with the highest greenhouse gas emissions (see, for e.g., this UN data on kilograms of emissions per kg of food) — owing to factors including land use, methane emissions from livestock and nitrous oxide emissions from the waste produced by animals. So biotechnologies applied to food production which can replace the need for us to get so much protein from animal sources have the potential for radical reductions in emissions if we integrate these new processes into our food systems.
Asked about the regulatory challenge of building an alternative protein business in Europe, Bon Vivant’s co-founder, Stéphane MacMillan, offers two thoughts. On the one hand he sounds sanguine — suggesting high food safety standards in the EU could create a competitive advantage for local startups over time, as a sort of ‘gold standard’ mark (i.e. once regulatory clearance to sell locally is obtained, which he estimates in their case may take two to three years vs a quicker anticipated time-to-market over in the US).
“Everyone is saying, well, it takes too long in Europe to get approval. Okay, it’s taking longer than any other countries but at the same time we have to be proud of standards that we have in Europe,” he tells TechCrunch. “These standards are also the reason why European food is really seen as the best class in most parts of the world. So we have to comply with it. It takes a bit more time. But, at the same time, I think… that guarantee for the consumer that our products are absolutely non-GMO — that’s really important and [builds trust] with customers.”
But he also suggests the bloc’s policymakers need to find “the right balance” — between having such high homegrown standards and risking a future where European consumers are forced to buy foreign bio products “because we were not able to build the champions”.
“It’s not black or white,” he suggests. “It’s a balance that we need all to find collectively. Both are right. But we just to find the right balance.”
Offering an investor perspective on the same point, Sofinnova’s Bobanović sees even less upside for EU biotech startups trying to turn increasingly strict regional food safety standards into a competitive advantage. So — at the least — the suggestion is the bloc shouldn’t be looking to pile more rules on the sector if it’s serious about growing the bioeconomy.
“While Europe’s stringent rules might enhance consumer trust in certain sectors, it’s unlikely the case for biotech,” he argues. “Unlike the luxury industry where ‘made in Europe’ is an advantage most food products are destined for local consumption and consumers already trust regulations. Increased regulation is not likely to influence product adoption.”