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 Europes 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 Europes average, Gross Value Added grew 1.5 times as quickly, and productivity was 2.5 times higher. Europes 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:

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 Europes 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. Europes 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.

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Ambition and urgency: Biotechnology and Biomanufacturing in the EU - EURACTIV