Questions and answers on the Communication on Biotechnology and Biomanufacturing

How are biotechnologies and biomanufacturing currently used in industrial sectors?

Biotechnology and biomanufacturing, i.e., the use and conversion of biotechnology and biological resources into chemicals, products and energy, are transforming diverse industrial sectors including chemicals, textiles, cosmetics and agri-food, and bringing new, sustainable consumer products to the markets. 

Biorefineries, facilities used to convert biomass into a range of bio-based materials, can also transform wood into innovative high value-added products: biochemicals, insulation foams, bio composites, engineered foams etc. One European company is developing batteries made from hard carbon powder (refined lignin) with a scalable model for commercial production.

In textiles, biotechnology presents an environmentally sustainable alternative, particularly in dyeing, printing, and finishing processes. Enzymatic processing reduces water and energy consumption, contributing to lower environmental impact.

In the health domain, mRNA therapeutics allowed the discovery of mRNA-based vaccines for COVID-19, saving millions of lives. In addition to vaccines against infectious diseases, RNA therapeutics are being developed to treat cancer as well as rare and cardiovascular diseases.

In the agri-food sector, biotechnology enhances crop yields, provides resistance to pests and diseases, reduces environmental impact and improves food quality and nutritional content.

What is the role of biotechnology in the EU economy?

Biotechnology is one of the fastest growing innovative industries in the EU with a high labour productivity. Biotechnology contributed directly EUR 31 billion to its overall GDP, created 210,700 direct jobs in healthcare, industry and agriculture, as well as supported 625,700 jobs (indirect and induced) in the overall economy.

What are the advantages of products made of bio-based materials or clothes made of recycled, bio-based fibres?

Products crafted from sustainable bio-based feedstock can carry numerous benefits for the economy, society, and the environment. Such choices not only encourage businesses and consumers to adopt sustainable practices but also foster innovation. 

For example, opting for a children's toy made from bio-based materials or clothes fashioned from recycled, bio-based fibres can bring advantages in terms of environmental impact, biodegradability, resource conservation, energy efficiency, circularity, and littering minimisation. Bio-based materials are derived from renewable resources reducing reliance on fossil fuels and possibly lowering carbon emissions. Likewise, clothing made from recycled, bio-based fibres can help decreasing the environmental footprint associated with traditional textile production. Using recycled materials in clothing conserves natural resources by reducing the need for virgin raw materials. This supports sustainability by decreasing the environmental impact of resource extraction and processing. 

Beyond environmental benefits, bio-based products can enhance the competitiveness and modernisation of our economy. With their substantial growth potential and high labour productivity, these products contribute to the economic growth of the EU, fostering job creation.

Bio-based materials and products tend to be more expensive than fossil-based equivalents. Does the Communication include any measures to address this issue?

The Communication proposes several measures to tackle the problem.

To succeed on the market, bio-based products need to prove their sustainability and lower environmental impact when compared, for instance to petrochemical products. The Life Cycle Assessment (LCA) is the key methodology for assessing the environmental impacts of products. While different LCA approaches have been developed, the Commission recommends the Product Environmental Footprint (PEF) approach which was last reviewed in 2021. In its next periodical revision (in 2025-2026), in light of recent scientific developments, the Commission 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 feedstock 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. Such requirements could be established, in line with the EU's international commitments, through delegated acts under the new Ecodesign for Sustainable Products Regulation.

On the consumer front, the Commission will explore how bio-manufactured non-food products could profile themselves better through labelling of bio-based products. This would inform consumers about the bio-based content of a product, creating awareness and allowing consumers to make informed choices. When consumer demand for bio-based products increases, manufacturers may respond by scaling up production, leading to economies of scale and potentially lowering production costs. Several markets pull measures can boost the commercialisation of innovative biotechnology and biomanufacturing solutions. Simplifications to regulatory frameworks and streamlining approval processes, aim to foster innovation, provide clarity, and reduce costs for consumers thus accelerating the entry of products into the market.

Why is intellectual property important for the biotechnology and biomanufacturing sector and what will the Commission do in this context?

Intellectual property (IP) plays a key role in the biotechnology and biomanufacturing sector, as it allows biotech innovators to protect research results and thus to recover the large upfront capital investments needed. It is also frequently a critical asset which emerging biotech start-ups can offer to secure financing. Providing a stable, predictable, and balanced IP framework for protecting and valorising biotech innovation and facilitating access to it is thus crucial for ensuring a vibrant biotech ecosystem in the EU.

The Commission will continue encouraging the remaining Member States to join the unitary patent system and will support a swift completion of the negotiation on the proposed reform of the legislation on supplementary protection certificates (SPCs) by the co-legislators, to cut costs and administrative burden, while enhancing legal certainty and transparency in the biotech ecosystem for patents and SPCs.

What could the EU do to attract biotech and biomanufacturing investments?

To attract investments in Europe, the EU can leverage a broad range of financing instruments to support biotechnology and biomanufacturing (e.g., Horizon Europe also through the  Circular Bio-based Europe Joint Undertaking (CBE JU); Innovation Fund; InvestEU). Furthermore, HERA Invest provides a financing mechanism to attract private investment targeting SMEs to promote advanced research and development of medical countermeasures and related technologies. For European high-growth tech companies in their late-stage growth phase, the European Investment Bank (EIB) European Tech Champion Initiative (ETCI) can be used to provide growth financing.

Moreover, biotechnology will benefit from the Strategic Technologies for Europe Platform (STEP), which aims to boost investments in critical technologies across the digital, clean and biotech sectors, using existing funding instruments, such as the Horizon Europe Programme, the European Defence Fund, InvestEU or cohesion policy funds and the Recovery and Resilience Plans.

The Commission will advocate for the inclusion of biotech and biomanufacturing as part of the European Innovation Council (EIC) accelerator Work Programme 2025 to develop and scale-up innovations.

Finally, the Commission will launch a study to identify barriers and ways to support the consolidation of investment funds, stock exchanges and post-trading infrastructure in order to better fund later-stage growth of EU high-tech scale-up businesses, including in biotech.

What is the link between this Communication on biotechnology and biomanufacturing and the EU's Bioeconomy policy framework?

Biotechnology and biomanufacturing are important technologies to reach the objectives of the EU Bioeconomy Strategy. The upcoming review of the EU Bioeconomy Strategy will consider how biotechnology and biomanufacturing can be supported and developed.

The bioeconomy covers all sectors and systems that rely on biological resources, their functions, and principles. It includes and interlinks land and marine ecosystems and the services they provide; all primary production sectors that use and produce biological resources and all economic and industrial sectors that use biological resources and processes to produce food, feed, bio-based products, energy, and services. To be successful, the European bioeconomy needs to have sustainability and circularity at its heart. This will drive the renewal of our industries, the modernisation of our primary production systems, the protection of the environment and will enhance biodiversity.

How will the Commission boost Artificial Intelligence (AI) on biotechnology?

The Commission invests in AI-powered advancements in all fields of science, including biotechnology, through its funding programmes for research and innovation and digital technology.

The application of AI in science is one of its most promising and exciting uses. In a policy brief published in December 2023, AI in Science, the Commission explores ways to leverage AI to advance and accelerate scientific discovery for the benefit of society. These include assessing the appropriateness of new foundation models for science and other AI research assisting tools, specialised for scientific work. One of the most groundbreaking examples of AI applications in biotechnology is the collaboration between the European Molecular Biology Laboratory  and DeepMind's AlphaFold to map and publish over 200 million protein structure predictions, including the entire human proteome.

To further facilitate such scientific breakthroughs, Horizon Europe, the largest multilateral research and innovation programme in the world, invests in AI-powered advancements in all fields of science, including biotechnology. The EU-funded company AMADIX, leveraging AI for colorectal cancer detection, the DrugComb project for personalised cancer treatment, the AIDD project for drug research and the AI4LIFE project, enhancing access to AI-powered image analysis for life scientists, exemplify the EU's commitment to integrating AI in biotech research and development.

Furthermore, the Commission's “GenAI4EU” initiative aims to stimulate the uptake of generative AI across the EU, an investment of €500 million by 2027 from Horizon Europe and Digital Europe programmes; and biotechnology is one of the priority sectors.

How can the Circular Bio-based Europe (CBE) Joint Undertaking and the Innovative Health Initiative (IHI) partnership contribute to innovative biotechnologies and biomanufacturing in Europe?

The Circular Bio-based Joint Undertaking (CBE JU) is a strategic public and private partnership instrument for Europe's biotech and biomanufacturing sector, scaling up production capacity of innovative bio-based chemicals and materials to commercial scaled.

Some projects managed by CBE JU are:   

• The PEFerence project is contributing to tackling the impacts of plastic waste on the environment and our health by bringing to the market 100% bio-based polyesters which are environmentally more sustainable than fossil-based equivalents and completely recyclable. The goal is to replace a significant share of fossil-based plastics with 100% bio-based polyesters based on FDCA for use in bottles, films and fibres. This innovative industrial scale, cost-effective biorefinery, located in Delfzijl (the Netherlands) is producing the bio-based chemical, Furan DiCarboxylic Acid (FDCA). It will be inaugurated and will be fully operational in September 2024.  

• The AFTERBIOCHEM flagship project in Saint-Avold (France) takes what is traditionally considered waste and through the use of a cutting-edge fermentation process is creating high-value products and solutions. This “first-of-its-kind” biorefinery is developing the first all-in-one chemical platform for transforming the sugar beet industry's side streams into bio-sourced chemicals for industry, with uses in food preservatives, cosmetics, and fertilisers. It is supporting local sugar beet famers in the region through the creation of new business models, diversifying revenue streams and creating new high-skilled green jobs. The plant will be inaugurated in early 2025.

The Innovative Health Initiative (IHI) funds many research projects that encompass biotechnology, as a critical and enabling technology for the development of numerous disease treatments and prevention strategies. IHI launches projects in disease areas with a high burden on patients and society, such as cancer or cardiovascular diseases.

Projects funded under IHI lay the grounds for developing new, safe and effective innovations such as diagnostics and treatments. In doing so, IHI also helps make the EU health industry stay globally competitive. IHI contributes to reaching the objectives of major EU policy initiatives such as Europe's Beating Cancer Plan, the new Industrial Strategy for Europe and the Pharmaceutical Strategy for Europe.  For example, the project ARDAT will deliver new knowledge, tools and standards needed to speed up the development of advanced therapy medicinal products, while the project IMMUCAN analyses the tumour microenvironment in 3000 patients to identify the biological markers that show which patients are most likely to respond well to immune therapies. The project PRIMAVERA is focused on predicting the impact of monoclonal antibodies and vaccines on antimicrobial resistance.

How can Industrial Biotechnology Innovation and Synthetic Biology Accelerator (EU-IBISBA) contribute to boost biotechnologies in the EU?  

The Industrial Biotechnology Innovation and Synthetic Biology Accelerator (EU-IBISBA) is a distributed research infrastructure that  aims to accelerate the movement of knowledge and early-stage research results in the areas of biotechnology and synthetic biology towards maturity and uptake for further development by industrial R&I. EU-IBISBA's expertise is within the field of industrial biotechnology and focuses on the integrated development of bioprocesses, making them operational for businesses.

EU-IBISBA supports research in industrial biotechnology by providing access to first-class facilities for all industrial biotechnology professionals. One of its main strengths is to offer a one-stop-shop of integrated R&D services across all the stage of bioprocess development. Other key strengths are promoting standardisation, interoperability and best data practices (Data are stored on the IBISBA Knowledge Hub ensuring integrity, security and privacy).

EU-IBISBA also helps developing smart solutions for biomanufacturing by integrating biotechnology with AI, digital twins and cloud technologies.

What is Horizon Europe doing to improve public knowledge and trust on biotechnologies?

Public trust is the key to accept biotechnology solutions in many areas of application.  Scientific based communication gives opportunities to ensure a balanced public risk perception and acceptance.

Two excellent examples of projects funded under Horizon Europe are:

• The B-TRUST project brings together partners from Member States to develop a transparent and inclusive governance model enabling the application of biotechnology to the bio-based and agri-food sector. More specifically, to (1) inform and create transparency related to consumer and environmental safety, (2) leverage engagement from citizens and other stakeholders, and (3) develop and exchange best practices.
• The European Consortium for Communicating Gene and Cell Therapy (EuroGCT) brings together 47 partner organisations and institutions across Europe with a goal of providing reliable and accessible information about the use of cells and genetic material to treat disease. EuroGCT provides (1) patients, people affected by conditions, healthcare professionals, and citizens with accurate scientific, legal, ethical, and societal information related to cell and gene-based therapies, (2) the research community with an information source on the practical steps needed for cell and gene therapy development.

How does the European Innovation Council (EIC), under Horizon Europe, contribute to supporting start-ups in the area of Biotechnology?

Through Horizon Europe, the EIC has provided around EUR 350 million support and investments to Biotechnology and Biomanufacturing from early-stage research to investments in individual startups and SMEs in areas such as   industrial biotechnology, healthcare biotech to novel foods (e.g., foods from cellular agriculture involving bacteria, yeasts, algae, and fungi).

The current EIC Work Programme includes a targeted call focused on “Food from Precision Fermentation and Algae” (global market forecasts point to a more than x20 increase in investment in proteins from precision fermentation by 2030) and a further new area of activity, albeit more focused on earlier stage research, that provides opportunities for biotechnology-driven solar energy conversion to fuels and chemicals: Solar cell factories are unicellular microorganisms (cyanobacteria, microalgae) which convert sunlight, water and CO2 directly into a fuel or chemical with a broad range of possible products, ranging from hydrogen to synthetic fuels or pharmaceuticals.

Examples of Biotech companies funded by EIC are:

• Infinite Roots, formally Mushlabs, is a biotech company from Hamburg, in Germany, which has developed a fermentation technology to produce edible mushroom roots called mycelium. The biological process technology creates mushroom biomass rich in protein, dietary fibre and micronutrients with a savoury flavour from pieces of mycelium cultivated in a controlled and optimal environment.

• Hoba Therapeutics, is an early-stage biotech company based in Denmark, which developed innovative treatments for chronic neuropathic pain and sensorineural hearing loss through the discovery of a novel family of endogenous human proteins: meteorin and cometin. 

In addition, the Commission will advocate the inclusion of biotech and biomanufacturing as part of the European Innovation Council (EIC) accelerator Work Programme 2025 to develop and scale-up innovations.

How will the Commission continue to support the research and development of biotechnology and biomanufacturing for health?

Horizon Europe funds health biotechnology and biomanufacturing through R&I projects driven by scientific opportunities, e.g., European Research Council (ERC) and Marie-Sklodowska-Curie-Actions programme (MSCA), as well as R&I collaborations, networks, infrastructures, and partnerships, which provide European added value or call for a global approach. Consequently, biotechnology and biomanufacturing innovation is integrated in many health-related EU-funded actions with nearly 600 projects and €1.5 billion from Horizon Europe funding so far.

The Communication sets out a series of concrete actions that strive to cultivate an enabling environment for conducting R&I in the EU. This aims to boost the transfer of research results into medicinal products, preventions and diagnostics, by:

• Exploring the possibility to fund specific support to SMEs for the clinical development of biotechnology-based medicinal products, stimulating the technology transfer from “lab to fab”.
• Working on further improving and streamlining the clinical trial processes in the EU under the Accelerating Clinical Trials in Europe (ACT EU) initiative.
• Launching a study on the implementation of the Clinical Trial Regulation (CTR) to assess its impact on European clinical research and to prepare a report on the CTR's functioning.
• Introducing simplifications to the regulatory framework and regulatory sandboxes to test novel solutions, as proposed for breakthrough therapies under the reform of the pharmaceutical legislation.
• Exploring the possibility under IHI for regulatory sandboxes pilots for health products, laying the ground for supporting the most innovative products on their pathway towards reaching the markets and end-users, including most importantly, patients.
• Launching a study to assess the current landscape to identify how best to leverage existing assets and infrastructures for health biotechnology, including those developed under Joint Undertakings, to boost biomanufacturing capacity within the EU.