Biology, Regulation, and the pace of progress | Biosolutions

If biosolutions are ready, why are legacy regulatory systems still slowing their path into the real world?

In this second part of a three-part series, we examine the role regulation plays in the pace of biosolutions adoption. It explores how governance, risk perception, and regulatory systems influence innovation, while recognizing that the primary purpose of these systems — safeguarding people and the environment — must never be compromised. At the same time, it considers why identifying smarter ways to support innovation within these protective frameworks is becoming increasingly important.

Biosolutions hold immense potential. They are already deployed across multiple industries producing a wide range of everyday products. The scientific and policy literature on their promise is extensive, and rapid advances in biotechnology continue to expand that potential. Yet their widespread adoption continues to lag behind.

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The transition from an industrial-age production mindset to a biological one is happening more slowly than many people want. Why is progress not happening faster? 

In this episode of the Biosolutions Bulletin by Novonesis we examine why transformative technologies in biotechnology often face delayed adoption. We explore the role of governance, risk perception, and regulatory systems — and why balancing protection with innovation is becoming increasingly important.  
 
Biosolutions hold immense potential. They are already deployed across multiple industries producing a wide range of everyday products. The scientific and policy literature on their promise is extensive, and rapid advances in biotechnology continue to expand that potential. Yet their widespread adoption continues to lag behind.  

This is not a trivial delay. It significantly limits the potential of biosolutions, which at their core offer a more sustainable way of producing. Unlike conventional industrial systems that largely follow a linear path — extract, transform, and discard — biosolutions work in more circular ways, allowing materials to be reused, regenerated, and returned to the system. This shift can go a long way toward making industrial manufacturing less taxing on the environment and toward addressing some of the most pressing challenges we face today, including climate change, soil degradation, and growing pressure on natural resources. 

So what is holding back the full potential of biosolutions? 

There is no single answer. Several factors are in play — including the regulatory frameworks designed to protect society and consumers, varying levels of political will, and approval pathways that can be lengthy and administratively complex. There is also the question of societal acceptance, as well as limited awareness of the value biosolutions can deliver in key areas such as energy and food security. 

Among these factors, one stands out because it connects to all the others: the policy and regulatory frameworks that govern biotechnology. 

To understand why these frameworks look the way they do, it helps to trace their origins — back to a time when biotechnology itself was new and unfamiliar, and society was only beginning to work out how to approach it responsibly. 

New tools, new responsibilities 

For centuries, scientists worked to understand life by observing organisms, studying how they function, and gradually uncovering the structure of DNA. Progress was steady, but it followed a clear boundary: scientists could study and describe biological processes but had no way to work with them directly.  

That began to shift in the early 1970s. For the first time, researchers developed techniques that allowed them to work with genetic material directly, rather than simply observing it. This made it possible to work with genetic material in new, more precise ways — a capability that would, over time, open the door to applications few could have imagined at the time. 

Today, this is considered routine science, underpinning applications we now take for granted, including the production of insulin for people managing diabetes. However, in the early 1970s, none of these outcomes were yet visible. What existed was a new capability — and, naturally, a great deal of careful thought about how it should be used. 

In 1972, Stanford University biochemist Paul Berg conducted one of the earliest experiments using these new techniques, successfully combining genetic material from different sources. It was a significant scientific first — and, like many firsts, it prompted careful reflection within the scientific community about how the technology should be used moving forward. 

That reflection was not limited to a few voices. A number of respected scientists at the time called for careful consideration of how this technology should be applied before further progress. In 1974, they proposed a voluntary pause on certain types of experiments, allowing the field time to reflect on how best to proceed. 

This marked an early sign of something that would come to define the field: scientists choosing, of their own accord, to slow down and reflect before scaling up. That emerging culture of deliberate self-examination soon culminated in something unprecedented. 

The moment science chose caution 

In 1975, this mindset of careful reflection came to a head at the Asilomar Conference — a gathering that would go on to become one of the most defining moments in the history of biotechnology. 

At Asilomar, in California, around 150 scientists, mainly molecular biologists, came together not to accelerate discovery, but to think through its implications together. The discussions were thorough, and views varied. Some believed that scientific progress should continue without special restrictions, trusting that knowledge itself would provide answers along the way. Others felt the uncertainty around potential risks called for clear safeguards before moving further. 

The outcome of the conference was not a halt, but a framework. Research would continue, but under carefully defined conditions, with experiments categorized based on their level of risk and appropriate containment measures put in place. In effect, the scientific community chose to regulate itself, establishing principles that would go on to shape how governments later approached biotechnology. 

This was an extraordinary moment, not because science slowed down, but because it chose to move forward with caution. It set a precedent that other fields would later look to. 

Even as scientists were working to manage these risks from within, the conversation was already beginning to move beyond the laboratory — into the hands of the public, and soon after, into the realm of politics. 

When society stepped in 

By the mid-1970s, recombinant DNA (the combination of genetic material from different sources) had begun to attract attention far beyond scientific circles. The questions it raised were no longer confined to research institutions; they had entered public discourse. 

This shift became particularly visible in 1976, in Cambridge, Massachusetts. A proposal to build a research facility at Harvard University prompted local residents to ask questions about oversight and safety.  

The debate that followed went beyond technical detail. It reflected a broader, reasonable expectation: that decisions about new science should involve the communities affected by it.  

In 1977, the Cambridge City Council passed an ordinance regulating recombinant DNA research, allowing it to proceed but under stricter local oversight. This became one of the earliest examples of a local government working alongside its community to set ground rules for biotechnology. 

The significance of this moment lies not just in the ordinance itself, but in what it represented: Biotechnology moved beyond the laboratory and into the public sphere. It was no longer only a scientific question. It had become a societal one. Decisions about how far the technology should go, and under what conditions, were now being shaped not just by scientists, but by citizens and policymakers working together. 

A world already shaped by chemical consequences 

To understand why this new technology was met with such caution, it is worth remembering what the world had just experienced. 

The 1970s and 1980s were decades during which the environmental and human costs of industrialization were becoming increasingly visible. For the first time, societies were confronting the unintended consequences of large-scale chemical use across ecosystems and populations. 

Issues such as air and water pollution had gained global prominence. Acid rain was damaging forests and lakes across regions. The widespread use of pesticides like DDT had raised serious concerns about long-term environmental and health impacts. By the mid 1980s, the discovery of the ozone hole showed that everyday chemicals – used in products like refrigerators and air conditioners – could affect the planet’s atmospheric systems in ways no one had anticipated. 

Alongside these developments were major industrial accidents — including Love Canal in the United States, where toxic waste contaminated a residential area, and the Bhopal and Seveso disasters, both major chemical plant accidents in India and Italy, respectively, with severe human and environmental impacts — that made it clear how serious the consequences of poorly managed chemical use could be. 

Taken together, these events revealed a clear pattern. Technologies that were introduced with confidence and clear benefits could, over time, produce consequences that were neither anticipated nor fully understood. 

This was the backdrop against which biotechnology began to take shape in public consciousness. 

So when a new technology emerged, it wasn't viewed in isolation — it was viewed through the lens of recent experience with chemicals.  

And that experience had taught the world a useful lesson: innovation can sometimes move faster than our understanding of its risks — which is exactly why building careful oversight in from the start matters. 

Fun facts: 

1. Is there really a crisis of trust in science? We often hear that trust in science is fading. Well, that might not be true, at least according to a study in which researchers surveyed over 70,000 people across 68 countries. They found something surprising: most people still trust scientists. Not just that, but many actually want scientists to have more influence on society and policymaking.  
    
2. More science around us… yet we feel less informed: If trust in science is not the problem, then what is? A study from the UK offers an interesting clue. Today, people are more exposed to science than ever before through news, social media, and everyday conversations. And yet, only around 43% say they feel genuinely informed about it. At the same time, nearly half of respondents neither agree nor disagree that the information they hear about science is “generally true.” More science is reaching people than ever before. But not always in a way that makes it easier to understand. 
    
    
    
3. One of the most debated food technologies is not universally known: Genetically modified ingredients have been at the center of public debate for decades. And yet, across Europe, only 56% of people say they have even heard of them. Awareness drops further for newer developments — just 29% are familiar with genome editing, and only 25% have heard of nanotechnology in food production.  
    
    

 From breakthrough to framework 

In just over a decade, from 1972, when Paul Berg first demonstrated the new technology to the mid-1980s, the field evolved rapidly. What began as a laboratory breakthrough did not remain confined to research settings for long. The new technology began moving into industrial use, becoming part of manufacturing processes in sectors such as pharmaceuticals and food production. 

Some of the earliest applications emerged during this period, including the production of human insulin in 1982, followed by enzymes used in products like detergents and bread. Over time, its use expanded across industries —from healthcare and agriculture to food processing and consumer goods — laying the foundation for many of the applications we see today. 

As the technology matured and moved from controlled experiments into real-world use, it understandably drew attention. Across countries and regions, regulatory agencies began to step in. The question was no longer whether biotechnology could work, but how it should be regulated and governed. 

By the mid-1980s, this shift had begun to take shape. In 1986, Denmark enacted the Gene Technology Act, the world’s first national law specifically regulating biotechnology. Just weeks later, the United States introduced its Coordinated Framework for the Regulation of Biotechnology, outlining how existing regulatory agencies would oversee the field. Soon after, the European Union followed through with directives that set the conditions under which biotechnology could move beyond the laboratory and into wider use.  

Different countries took different routes. Some chose to adapt existing regulatory systems, while others developed new frameworks tailored to the emerging technology. And yet, despite these differences, there was a common thread. Their primary aim was to ensure safety, manage risk, and prevent unintended consequences. 

This emphasis is understandable: These laws did not emerge in isolation, but in a world that had recently learned, through hard experience, the importance of getting oversight right — particularly around chemicals. 

By the time biotechnology entered the scene, societies had developed a structured way of thinking about risk: how to test new substances, control their use, limit exposure, and respond when something went wrong. In this context, caution was not merely a preference, but a learned response. 

So when faced with biotechnology, policymakers drew on this experience, applying the same rigor - risk assessment, control, and careful oversight – that had come to define responsible regulation more broadly. It was a sign of how seriously the field was being taken from the outset.  

Why this matters now for biosolutions 

The story we have traced so far does not end in the past. It continues to shape what happens to biotechnology today, how it is regulated, the steps it must go through from discovery to application, and how quickly its benefits reach society. 

Over the past few decades, biotechnology has steadily moved beyond laboratories and into industrial settings, finding applications across sectors ranging from pharmaceuticals and agriculture to materials and manufacturing. 

What we now describe as biosolutions is a continuation of the biotechnology journey. In many cases, they work through biological processes that enable a more circular use of resources, reducing waste, and making better use of what already exists. Here, biology is not just studied, but used deliberately to produce everyday products, improve processes, and reduce our reliance on resource-intensive and fossil fuel-based materials. 

In simple terms, biosolutions are just biotechnology applied at large scale in real-world settings. It's often at this exact stage — when a technology is ready to be deployed widely — that progress can slow. This is usually driven less by the robustness of regulatory systems and more by how well they are coordinated with one another. 

Bringing a new biosolution from the laboratory to the real world is rarely a straightforward journey. It involves navigating multiple layers of assessment, different regulatory authorities, and requirements that vary across sectors and countries. Even when the underlying science is well understood, the pathway itself can be long, complex, and, at times, difficult to predict. 

The European Biosolutions Coalition, for instance, points to regulatory complexity, limited coordination, and differing rules across member states — creating what it describes as a patchwork of regulations. Approval processes can be lengthy, and administrative procedures are not always easy to navigate. What is often missing isn't safeguards but simplification and coordination across the system. 

In practice, this means that the journey from idea to application is not a single, coordinated pathway. A solution may move through multiple stages, each governed by different requirements and authorities. Processes do not always align seamlessly, and scientific breakthroughs can take considerably longer to reach people than the underlying science alone would suggest. The result is that valuable innovations — including biosolutions that play a key role in sectors like manufacturing, energy security, and food production — can take longer than necessary to reach those who would benefit from them. 

This broader pattern becomes even clearer when you look at how specific technologies move through the system. An analysis by the OECD highlights similar structural challenges — overlapping frameworks, regulatory fragmentation, limited flexibility, and lengthy approval timelines. 

In some cases, these challenges have very visible consequences for access to innovations that have the potential to address some of the most pressing political and societal priorities.  

For instance, in the case of animal feed enzymes and probiotics, estimates suggest that approval in South Korea can take around two months, compared to the EU where the process may take up to 15 times longer (2.5 years). For dietary supplements, estimates indicate that regulatory approval takes approximately 11 months in Brazil, whereas in China the process can take up to around 42 months (3.5 years).  

What this reveals, isn’t that some systems are too cautious and others too lax – it’s that different parts of the global system move at different speeds, with limited coordination between them. A product may be considered acceptable in one context, yet face a much longer pathway in another. So, the challenge is not just whether a solution works. It is how easily it can move through a system that wasn't always designed with today's pace of biological innovation in mind. 

 When familiar biology meets a system built for caution 

Many biosolutions today are built on biological processes that are not new. Fermentation, enzymatic reactions, and microbial activity have been used safely for decades, in some cases for much longer. What is new is not always the biology itself, but how it is applied, scaled, and integrated into modern industrial systems. 

The regulatory pathways they must navigate do not always reflect that track record yet – which is why the conversation around regulation is beginning to shift. 

Across Europe, there is growing recognition that existing frameworks, while built on sound principles, may need to evolve to better support the role biotechnology is now expected to play. The European Biosolutions Coalition, together with counterpart organizations in Brazil and North America, calls for faster and more coordinated approval pathways, clearer and time-bound processes, and a move towards evaluating technologies based not only on their risks, but also on their potential benefits. It also highlights the need for improved incentives for scaling and infrastructure, along with greater investment in research, innovation, and public awareness. 

These are not calls to weaken regulation. They are calls to make it more responsive to how biotechnology, and biosolutions in particular, are developing today. 

Seen in this light, the underlying question becomes clearer: Not whether protection is needed — it clearly is and should remain non-negotiable — but whether the systems delivering that protection have kept pace with how the technology itself has developed. 

If biosolutions are to move from promise to practice, the systems that govern them can evolve to become more coordinated and efficient, without compromising their protective purpose. Businesses have an opportunity to help shape that evolution, working together with policymakers and regulators to build regulation that is fit-for-future and not based on the past. 

But regulation is only part of the story. Because even the most forward-looking policy cannot, by itself, create public trust, shift old habits, or make a new way of producing feel natural and desirable. For that, something deeper must also change: How society understands biology, how innovation is communicated, and how unfamiliar ideas become accepted over time. We’ll dive more into that in our third article in this series.