The "Supporting Biotechnology and Bioproduction in the EU" initiative offers promise, though not yet commitment, for biotechnology in the EU at the scale and vision necessary for global significance, states Euractiv.

Ambition and Vision

"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 addressing existing barriers to growth.

The world is accelerating industrial biotechnology production, and we must go along with it. EuropaBio will be a partner and champion every step of the way to deliver Europe's biotechnological future." Dr. Claire Skentelbery, Director General of EuropaBio.

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

Ultimately, it recognized the economic footprint of biotechnology and its vital role in a globally competitive region.

Between 2008 - 2021, biotechnology employment growth was seven times higher than the European average, gross value added increased 1.5 times faster, and productivity was 2.5 times higher. European research has thrived in biotechnology, creating thousands of startups and enabling companies of all sizes to mature economic and societal value.

Let's not be modest about what biotechnology achieves. Health biotechnology is becoming the primary source of new therapies, making previously untreatable diseases manageable and transitioning from "management" to "cure" with increasing frequency, freeing patients, families, and health systems.

Industrial biotechnology holds the key to sustainable and innovative production, offering new and more sustainable substitutes, reducing dependence on fossil resources, including energy, alleviating pressure on ecosystems, and strengthening supply chains, including food production, which are essential as the world seeks to improve both resilience and adaptation to climate change.

From Initiative to Implementation

This is not Europe's first political roadshow for biotechnology. In 2007, the Mainstream Market Initiative began with the statement "Developing an innovation-based economy is crucial for competitiveness," and in 2024, as biotechnology demonstrates its commercial speed, the EU lags behind other global regions in biotechnology performance.

This Initiative, launched in the final days of the current Commission, must take root, grow, and flourish rapidly. It must quickly turn rhetoric into political and legislative action for competitiveness, enabling innovators to thrive and creating long-term investments in infrastructure, jobs, and skills in Europe.

The ambition for a Biotechnology Act is commendable, but action is urgently needed now. Tomorrow's reports do not replace today's progress.

A global game - Is Europe a player?

Europe lags behind in recognizing and utilizing biotechnology and bioproduction. EuropaBio has watched as global regions publish comprehensive, funded, time-bound and goal-based strategies, the US, China, Japan, India, and the UK building from their strong scientific foundations.

Winners of this global biotechnology race will hold primary market positions for new drugs, resilient local production, and global supply chains, all supported by high-value technology, workforce participation, and high skills. It is essential for the EU to be in this race to be more of a player than a customer.

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

Call it by its real name

The Initiative directly refers to important applications and components of biotechnology; food and animal feed, environmental remediation, new and alternative molecules for application in processes and sectors, advanced healthcare, with terminology that includes microorganisms, enzymes, mRNA, ATMPs, biorefineries, and bio-based products.

This must continue and expand (fermentation notably stands out by its absence) as part of biotechnology's visibility and recognition for all stakeholders, including decision-makers at national and European levels and citizens already benefiting from its advancements.

Legislation for innovation in biotechnology

Recognition of innovation in biotechnology should be an integral part of our legislative DNA, and yet, at the EU and Member State levels, we are already tying our own shoelaces:

General pharmaceutical legislation has a dampening effect on biotechnological innovation. EuropaBio's study on the impact of GPL on innovation showed that over 50% of new therapies between 2018 and 2022 with orphan designation came from emerging and small companies, yet reduced orphan market exclusivity will hit these smaller innovators hardest, while reduced regulatory data protection erodes the essential investment benchmark for new medicines.

Genome editing techniques are the scientific foundation from which biotechnology innovation grows, yet plant legislation is stalled and innovation protection is threatened. The consequences of failure to progress such fundamental legislation come at a high price for Europe's innovation and competitiveness ambitions across all sectors.

Built for biotechnology, built for Europe

The Initiative rightly identifies regulation as a critical component for the economic and societal success of such a transversal frontier technology. Complex, uncertain, and opaque regulatory pathways create a market path that is too slow, costly, and vague for investment.

Europe needs a future-proof, transversal framework built for biotechnology that recognizes its unique requirements and does not retrofit its systems built for chemistry and simplifies and removes obstacles from existing regulations.

Introducing regulatory sandboxes and simplified and accelerated market recognition pathways for biotechnology parameters are essential in this regard. Regulation must mature alongside innovation and is part of Europe's successful industrial growth from Europe's strong research base. A EU biotechnology hub will also provide welcome additional support for companies to navigate the complex and often overwhelming regulatory framework across all sectors.

The Initiative importantly identifies "regulatory obstacles arising at national or other governance levels hindering an efficient single market," which must be addressed urgently now.

As the Enrico Letta report nears publication, there is a risk of fragmenting the single market for biotechnological products and processes due to lack of coherence in the EC and Member States. This represents an opportunity for Europe to lead global coherence for biotechnology.

Beyond regulations, the proposed review of the Product Environmental Footprint (PEF) brings much-needed focus on sustainability benefits of products through assessing fossil and bio-based products for equivalence.

Biomass is another vital conversation for Europe, as part of the initiative, with a fundamental need for sustainable biomass, including primary. This creates a delivery path for biotechnology along the value chain, from innovation to market and consumer.

A framework for financing

The Initiative addresses finance but must be more ambitious for investment growth, particularly for expanding and maturing technology to market and must also be explicit and vocal about the technologies it is trying to support if the EU wants to lead an informed and engaged public narrative. Europe's investment landscape is more fragmented and conservative than in other regions.

Improving the investment landscape to enable the creation, financing, and maturation of European biotechnology companies will contribute to rebuilding the innovation ecosystem, but also other industries. The easier small and emerging biotechnologies find investment and partners in Europe, the more likely they are to remain and grow in Europe.

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