Brussels, 20 March 2024 - EuropaBio welcomes the Biotechnology and Biomanufacturing Initiative, whilst calling for ambition and urgency in its implementation. The Initiative recognises that biotechnology is one of the major global technologies shaping our health, food, and industrial footprint with sustainability and resilience, whilst also significantly outperforming EU averages for economic and employment growth. If Europe is to succeed, this Initiative has to rapidly transform ‘rhetoric’ into policy and legislation action for competitiveness, enabling innovators to thrive and grow, and creating long term investment into infrastructures, employment and skills in Europe.

Whilst EuropaBio welcomes the positive start, it calls for immediate action to address many of the bottlenecks that already create a drag on investment, scale up and market access, which in turn limit citizen and economic benefits. Studies and reports tomorrow are not a replacement for action today, especially when we can improve implementation of current regulations right now across EU and Member States. The Initiative must also 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.

Dr Claire Skentelbery, Director General of EuropaBio added “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.”

The Initiative potentially foresees a Biotech Act, which we also welcome, and rightly identifies the vital components for success of such a cross-cutting frontier technology. Complex and opaque regulatory pathways create a market pathway too slow, costly, and uncertain for investment, whilst the capital market for scale up or clinical trials in Europe is weak.

It is positive that the multi-Directorate Initiative recognises Europe’s need for a future-looking and cross-cutting legislative framework built for biotechnology to streamline and remove obstacles in existing regulations. EuropaBio welcomes the introduction of regulatory sandboxes and simplified, accelerated pathways to market. Regulation must mature alongside innovation and is core to successful industrial growth from Europe’s strong research base. In addition, an EU Biotech Hub will provide welcome additional support for companies in navigating the complex and often overwhelming regulatory framework.

Within industrial biotechnology, 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; the recognition of the existing value across sectors and the fundamental need for sustainable biomass, including primary biomass. This creates a pathway for action throughout the value chain, from innovation to market and consumer.

Within health biotech, the transformative nature of biotechnology and positive impact on health systems are recognised. Many initiatives have already been adopted or proposed, and it is critical they contribute towards the ambitious objective of European leadership for health biotech.  Legislation should focus on accelerating the translation of science into therapies, extending innovation capacity for faster and wider patient access in the EU.

EuropaBio is committed to work in partnership with policymakers and all interested parties to ensure the EU can deliver on the objectives of this new Initiative.