Introduction: A point of reflection and renewal for biotechnology in Europe
As the EU looks ahead to the European elections in 2024, with a new EU Commission mandate and Work Programme, EuropaBio reviews European strategies and ambitions where biotechnology plays a key role. Ursula von der Leyen’s State of the European Union address of 13 September announced an ‘EU Biotech and Biomanufacturing Initiative’ under the heading of ‘An Economy that Works for People’. Europe needs to be ambitious for this, particularly when considering the ongoing changes in global perspective on biotechnology which were highlighted in the 2022 Vilnius Statement.

The announced EU initiative is the latest indication of a greater point of recognition and acceleration for biotechnology: the 2023 announcement of the STEP (Strategic Technologies for Europe Platform) regulation prioritises biotechnology alongside clean tech and deep and digital tech whilst the EU Commission listed biotechnology as one of four critical technologies for Europe2. Earlier in 2023, the Swedish Council Presidency adopted conclusions on the bioeconomy3, and the Spanish Council Presidency has made the New Genomic Techniques for plants file a priority.

Building on this momentum, the EFIB Rotterdam Statement of 2023 provides a priority pathway for biotechnology to support Europe’s global leadership, resilience and competitiveness.

Industrial biotechnology for a sustainable and resilient global Europe
Industrial biotechnology uses enzymes, microorganisms and living cells to make biobased products from renewable raw materials. This is a key enabler of the EU’s transition from a fossil-based economy to a green and competitive bioeconomy in multiple sectors, including chemicals, pharmaceuticals, food and feed, fragrances, detergents, paper and pulp, textiles and bioenergy.

A global technology race is underway in the industrial biotechnology sector. The winners will lead global manufacturing and trade in several sectors. Their economies will be more competitive, sustainable and resilient. By reducing their dependency on non-renewable resources and harnessing a broader range of food and feed production technologies, they will strengthen their strategic autonomy and food security.

Despite its strong science and research base, and the EU Commission’s recent announcements on its ambition for European leadership in new technologies, Europe now needs urgent and immediate actions to create impact from these good intentions and to reinforce its competitiveness.

The EU must start with a bioproduction scale-up coupled with a regulatory environment that encourages investments in research and development and which fosters innovation. The EU must also provide
incentives that attract the best in class for skills, in both business and biomanufacturing.

EFIB Rotterdam Statement – a renewed direction for Europe
The inaugural 2021 EFIB Vienna Statement set the stage with three long term asks: 1) Modernising regulation and policy; 2) Education and awareness and 3) Financing innovation. The 2022 EFIB Vilnius Statement built on these asks, with specific priorities. The 2023 EFIB Rotterdam Statement focuses on Europe’s global position in the context of the 2024 EU elections.

Ask 1: Modernising regulation and policy: enabling impact
Political awareness of new genomic techniques (NGTs) has been steadily increasing over recent years. However, current discussions on NGTs for plants and the modernisation of the EU GM framework must be extended to microorganisms in the next mandate, as there is a critical and urgent need for a science-based, pragmatic, future-proof and regulatory framework covering the use of microorganisms across all sectors.

Biotechnology and biomanufacturing, by their very nature, offer products and processes that can be implemented across sectors. Enabling regulation must therefore be underpinned by coherent over-arching policy frameworks across industrial applications. This requires re-positioning and connectedness across EU institutions.

Following the proposed new regulatory framework for NGT plants, the EU Commission should publish a proposal for additional policy actions for microorganisms by Q4 2024.

Ask 2: Education and awareness: enabling a global perspective for Europe
Resilience and strategic autonomy are global buzz words. This is achieved through multiple pathways, beyond the essential local foundation of capacity and skills. Europe must ensure that it plays a vital role within global supply chains and value-added networks at strategic locations to remain a global decision maker. This will enable Europe to be competitive and resilient whilst strengthening global supply chains to the expected standards and equitability.

Europe should be an active player in global value chains and value-added networks by establishing strategic priorities for European biomanufacturing.

Ask 3: Financing innovation: enabling technologies
The European biotechnology sector has a strong focus on research, innovation, and sustainable economic growth. This is manifested by the Circular Bio-Based Europe Joint Undertaking (CBE JU) which accelerates the development and up-take at scale of bio-based innovative solutions. The European Innovation Council also recognises the challenges for growth in small companies, with a combination of grant and equity mechanisms. Both programmes highlight the critical need for sustainable and long-term biotechnology sectoral growth: a clear investment pathway from R&D to market access is required to scale up upcoming companies in Europe.

Sustainable financing needs to be aligned with overall sustainability and industrial ambitions. It needs to foster innovation, and be bold and farsighted in supporting investment into implementation at industrial scale, with resulting benefits manifested from Europe’s ambitions in biotechnology.

A clear investment pathway from R&D to scaled market access is needed to advance technologies to maturity whilst supporting activities within Europe.