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Present socio-economic, demographic and environmental challenges are reinforcing the bio-economy’s industrial dimension and its closer links with the biotechnology and bio-manufacturing sectors. Corresponding Commission’s actions will contribute to stronger economy in the member states and stimulate the demand and market uptake for bio-manufactured products.
Background
Biotechnology and its application to manufacturing bio-based products and bio-manufacturing in general is part of the solution to address many societal and environmental challenges, such as climate mitigation and adaptation, access to and sustainable use of natural resources, restoration of vital nature systems, food supply and security, and human health.
Biotechnology and bio-manufacturing are key for the competitiveness and the modernisation of the EU member states’ economy providing for high growth potential and increased labour productivity: they also strongly enhance the EU’s open strategic autonomy and resilience by reducing industry’s dependency on fossil-based input and other sources of raw materials, and increase circularity. These sectors will help advance the European Health Union and achieve the European Green Deal objectives.
Thus, the Commission’s communication to the Parliament, the Council, the ECOSOC and CoR in March 2024, “Building the future with nature: Boosting Biotechnology and Bio-manufacturing in the EU”, underlined that “more integrated approach to the technology’s transfer process in the states can significantly benefit biotech and bio-manufacturing companies”.
The Commission signified actions in three interconnected spheres: a) technology transfer capacity building (including training, knowledge development and sharing), b) technology transfer financing, and c) design of innovation systems of research organisations, technology transfer offices and research and technology infrastructures. Therefore, technology centers will be vital points in accelerating technology transfer and reducing the time-to-market for innovative products: i.e. in the EU there are already about 130 mapped technology centers active in biotechnology and bio-manufacturing.
International cooperation can leverage the EU’s strengths in biotech through knowledge sharing and industrial collaboration. The EU institutions will explore the possibility of launching international biotech and bio-manufacturing partnerships with key international partners, such as the US, India, Japan, South Korea, etc. to collaborate on research and technology transfer, and to explore possibilities for a strategic cooperation on regulatory and market access-related topics.
Note. According to the OECD, biotechnology is defined as the application of science and technology to living organisms, as well as parts, products and models of them, to alter living or non-living materials for the production of knowledge, goods and services. Advanced bio-technologies are geared towards various application areas, being the main ones medical and pharmaceutical (“red” biotechnology), agro-food (“green” biotechnology), and industrial and environmental (“white” biotechnology), with the marine biotechnology (so-called “blue”) gaining increased attention.
EU-wide set of actions
= Leveraging research and boosting innovation: To help to identify drivers and bottlenecks of innovation and of technology adoption, the Commission has launched a study to investigate the EU’s position compared to other global leaders in emerging biotechnology generation and transfer to the bio-manufacturing industry. To facilitate a more productive use of Research Infrastructures, the EU will explore ways to accelerate the development and use of the Industrial Biotechnology Innovation and Synthetic Biology Accelerator as a trusted digital repository and service network for the sector.
= Stimulating market demand: To succeed on the market, bio-based products need to prove their lower environmental impact when compared, for instance, to petrochemical products. The EU will review the assessment of fossil-based and bio-based products to ensure equivalence of treatment and incorporate methodologies for carbon storage in construction materials. To accelerate the substitution of fossil feed-stock and to stimulate the demand and market uptake of bio-manufactured products, the Commission will conduct an in-depth impact assessment of the feasibility of bio-based content requirements in specific product categories and in public procurement. Furthermore, the Commission will explore how bio-manufactured non-food products could profile themselves better through labeling of bio-based products.
= Streamlining regulatory pathways: there is a need for assessment of the EU legislation and its implementation to further streamline and reduce any fragmentation, explore potential simplification, and shorten the time to market for biotech innovations. Besides, all regulatory obstacles that arise at national or other governance levels which impede an effective single market will be void and the foundations for a possible EU Biotech Act will be created. The Commission will also work towards establishing an EU Biotech Hub, an operational tool for biotech companies to navigate through the regulatory framework and identify support to scale up, by the end of 2024. The Commission will further promote the establishment of “regulatory sandboxes” to test novel solutions in a controlled environment for a limited amount of time as a way of bringing more of them quickly to the market.
= Fostering public and private investments: The EU has a broad range of financing instruments to support biotechnology and bio-manufacturing such as Horizon Europe, including the Circular Bio-based Europe Joint Undertaking and the Innovative Health Initiative Joint Undertaking; the EU4Health program; the Innovation Fund; and the Strategic Technologies for Europe Platform, as well. To develop and scale up innovations with the potential to create new markets, the Commission will advocate the inclusion of specific challenges on biotech and bio-manufacturing in the European Innovation Council’s accelerator Work Program-2025. In line with the recent Eurogroup statement on Capital Markets Union, the Commission will launch a study by the end of 2024 to identify barriers and ways to support the consolidation of investment funds, stock exchanges and post-trading infrastructure in order to enable the development of the necessary scale, enhance the knowledge base, create deeper pools of liquidity and help lower the cost of financing for high-growth companies.
= Strengthening biotech-related skills: the “Large-Scale and Regional Skills Partnerships” can play a significant role in providing upskilling and reskilling opportunities on biotech and bio-manufacturing. A specific large-scale partnership for the biotech and bio-manufacturing could be explored, which can be co-financed through the Blueprint Alliance’s activity of the Erasmus+ program. The expanding number of dynamic European Universities alliances and Erasmus+ partnerships and alliances for innovation can also strengthen the development of skills required by the biotech sector.
= Elaborating and updating standards: The Commission will continue to encourage the elaboration and updating of European standards for biotechnology and bio-manufacturing to facilitate market access and innovation.
= Supporting collaboration and synergies: The Commission will encourage the deployment of technologies related to biotechnological processes and bio-manufacturing across EU regions through relevant Regional Innovation Valleys.
= Fostering engagement and international cooperation: the Commission will explore the possibility of launching international biotech and bio-manufacturing partnerships with key international partners to collaborate on research and technology transfer, and to explore possibilities for strategic cooperation in market-related topics. Through the Global Gateway and in line with its Global Health Strategy, the Commission will advance existing partnerships with Africa, Latin America and the Caribbean on manufacturing health products aiming to diversify global supply chains, overcome shortages of critical health products and reduce the global burden of disease.
= Using AI and generative AI: the EU will support structured exchanges with all interested partners to accelerate the uptake of AI, e.g. in particular Generative AI in biotech and bio-manufacturing (in the context of GenAI4EU). The Commission will raise awareness of facilitated access to the EuroHPC supercomputers for AI startups and the science and innovation community, in the course of 2024.
= Reviewing the Bio-economy strategy: The Commission will review the EU Bio-economy Strategy by the end of 2025 in order to take into account the current socio-demographic and environmental challenges, reinforcing the bio-economy’s industrial dimension and its links to biotechnology and bio-manufacturing to contribute to a stronger EU-wide economy.
Citation and references to: https://ec.europa.eu/commission/presscorner/detail/en/IP_24_1570.
Commission’s opinion
The EU member states are facing numerous challenges: e.g. climate change and resource scarcity, to name a few; biotechnology can contribute to solving these challenges. Biotech also largely supports Europe’s economy and contributes to the EU-wide competitiveness, with high growth potential and labor productivity. By reducing European dependency on fossil-based input and other sources of raw materials, biotech also increases circularity and strengthens states’ path towards independence from fossil fuels. Present proposal intends to create the right environment for this sector to grow and deliver global solutions to societal and environmental problems. Margrethe Vestager, Executive Vice-President for the Digital Age
More information in the following Commission’s websites: = Communication on Building the future with nature: Boosting biotechnology and bio-manufacturing in the EU; = Questions and answers; = Fact sheet; and = Biotechnology-European Commission.