Ambition and urgency: Biotechnology and Biomanufacturing in the EU [Promoted content]

The Initiative ‘Boosting Biotechnology and Biomanufacturing in the EU’ offers the promise, although not yet the commitment, for biotechnology in the EU at the scale and vision needed for global significance. EuropaBio looks inside and to the future.

Dr Claire Skentelbery is the Director General of EuropaBio.

“Ambition, vision and urgency are the calls from EuropaBio for this promising initiative. The next  Commission must combine long-term vision and bold ambitions with immediate and urgent attention to resolve existing barriers to growth. The world is accelerating industrial outputs from biotechnology, and we need to move with it. EuropaBio will be a partner and champion every step of the way to deliver Europe’s biotech future”. Dr Claire Skentelbery, Director General of EuropaBio.

Europe welcomed the Biotechnology and Biomanufacturing Initiative on March 20. It brought  recognition from the EU that biotechnology is one of the major global technologies shaping our health, food, and providing an industrial footprint with innovation, sustainability and resilience. The Initiative also recognizes the main bottlenecks, regulatory fragmentation, access to finance, value chain  obstacles and informed public recognition. 

Finally, it recognised the economic footprint of biotechnology and its vital role within a globally  competitive region. Between 2008 – 2021, employment growth from biotech was seven times higher than Europe’s average, Gross Value Added grew 1.5 times as quickly, and productivity was 2.5 times higher. Europe’s research has thrived within biotechnology, creating thousands of start-ups, and  enabling companies of all sizes to mature economic and societal value. 

Let us not be modest about what biotech achieves. Healthcare biotechnology is becoming the primary source of new therapies, bringing previously untreatable diseases within reach, and transitioning from  ‘manage’ to ‘cure’ with increasing frequency, freeing patients, families and healthcare systems. 

Industrial Biotechnology holds the key to sustainable and innovative manufacturing, delivering novel products and more sustainable replacements, reducing reliance on fossil resources including energy,  relieving pressure on ecosystems and strengthening supply chains, including food production, which are essential as the world aims to both ameliorate and adapt to climate change. 

From Initiative to implementation 

This is not the first policy roadshow for biotechnology in Europe. Way back in 2007, the Lead Market  Initiative opened with the statement “Developing an innovation-driven economy is crucial for competitiveness” and in 2024, whilst biotech is showing its commercial speed, the EU lags other global  regions for biotech performance. 

This Initiative, released in the closing days of the current Commission has to take root, grow and flower quickly. It must rapidly transform rhetoric into policy and legislation action for competitiveness, enabling innovators to thrive, and creating long-term investment into infrastructures, employment, and skills in Europe. The ambition for a Biotech Act is laudable, but there is urgency for action now.  Reports tomorrow are not a substitute for progress today. 

A global game – is Europe a player? 

Europe is late to the game in recognizing and utilising biotechnology and biomanufacturing. EuropaBio has watched global regions publish comprehensive, funded, time and target-driven strategies, with  the US, China, Japan, India and the UK building from their strong science foundations. The winners of  this global race for biotechnology will hold primary market positions for novel medicines, resilient local manufacturing, and global supply chains, all underpinned by high value, high employment and high  skills technology. It is essential that the EU is in this race to be a player rather than a customer. 

The Initiative acknowledges the importance of global dialogue, shaping biotechnology above Europe. The WHO, WTO, Convention on Biological Diversity and its Cartagena Protocol on Biosafety, as well as  the Kunming-Montreal Global Biodiversity Framework are all part of a harmonised global framework  for biotechnology where the EC must have a clear voice. 

Call it by its name 

The Initiative directly references important applications and components of biotechnology; food and feed, environmental remediation, novel and alternative molecules for application across processes and sectors, advanced healthcare, with terminology including microorganisms, enzymes, mRNA, ATMPs, biorefineries, and bio-based products. This needs to continue and expand (fermentation is notable by  its absence) as part of the visibility and recognition of biotechnology for all stakeholders, including  policymakers at national and European level and the citizens whom benefits already reach. 

Legislation for biotechnology innovation today 

Recognising biotechnology innovation should be integral to our own legislative DNA, and yet at EU and  Member State levels, we are already tying our own shoelaces together: 

• The General Pharmaceutical Legislation has a dampening effect on biotech innovation.  EuropaBio’s study on the impact of the GPL on innovation showed that over 50% of novel  therapies between 2018 – 22 with Orphan Designation originated from emerging and small companies, yet reduced Orphan Market Exclusivity will hit these smaller innovators hardest, whilst  reduced Regulatory Data Protection erodes the essential baseline for investment into novel  medicines. 
• New Genome Techniques are the scientific foundation from which biotechnology innovation  grows, and yet legislation for plants is stalled and innovation protection is under threat. The  consequences of failing to progress such fundamental legislation carry a heavy price for Europe’s ambitions for innovation and competitiveness across sectors. 

Built for biotechnology, built for Europe 

The Initiative rightly identifies regulation as a critical component for economic and societal success of such a cross-cutting frontier technology. Complex, uncertain and opaque regulatory pathways create  a market pathway too slow, costly and vague for investment.  

Europe needs a future-looking and cross-cutting framework built for biotechnology, recognising its  unique requirements and not retrofitting its systems built for chemistry, and streamlining and  removing obstacles in existing regulations. 

The introduction of regulatory sandboxes and simplified, accelerated pathways to market recognising the parameters of biotechnology are core to this. Regulation must mature alongside innovation and is part of successful industrial growth from Europe’s strong research base. An EU Biotech Hub will also provide welcome additional support for companies in navigating the complex and often overwhelming  regulatory framework in all sectors. 

The Initiative importantly identifies “regulatory obstacles that arise at national or other governance  levels which impede an effective single market” which is urgent to address now. As the Enrico Letta  report comes closer to publication, there is a risk of single market fragmentation for biotechnology  products and processes through lack of coherence across the EC and MS. This represents an  opportunity for Europe to lead global coherence for biotechnology.

Beyond regulations, the proposed Product Environmental Footprint (PEF) review brings a much needed focus on the sustainability benefits from products through the assessment of fossil-based and  bio-based products to ensure equivalence. Biomass is another vital conversation for Europe as part of  the initiative, with a fundamental need for sustainable, including primary, biomass. This creates a pathway for delivery for biotechnology throughout the value chain, from innovation to market and  consumer. 

A framework for finance 

The Initiative addresses finance but must be more ambitious for investment growth, particularly for  scale up and technology maturation to market, and it must also be explicit and vocal on technologies  that it seeks to champion if the EU is to lead informed and engaged public narrative. Europe’s investment landscape is more fragmented and conservative than other regions. 

Improving the investment landscape to enable the creation, financing, and maturation of European biotech companies will contribute to the restoration of the innovation ecosystem but also other  industries. The easier emerging and small biotech will find it to secure investment and partners in  Europe, the more likely they will be to stay and grow in Europe. 

EuropaBio will be a travelling partner for the Initiative, from its promising early days to its delivery through legislation and implementation, with success measure in ambitions achieved and benefits  measured for people and planet.