Annexes to COM(2024)137 -

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dossier COM(2024)137 - .
document COM(2024)137
date March 20, 2024
agreements.

Furthermore, the EU and the US will step up the work in the EU-US Trade and Technology Council and under the Science and Technology agreement to explore the opportunities of innovative and sustainable biotechnology and biomanufacturing solutions to address global challenges, such as climate change mitigation and adaptation, protecting biodiversity, improving health outcomes, and to partner up in addressing economic security risks on biotechnology.

The EU will continue working with its partners in the global UN policy frameworks such as the World Health Organisation, the Convention on Biological Diversity and its Cartagena Protocol on Biosafety, as well as the Kunming-Montreal Global Biodiversity Framework to ensure safe and sustainable use of biotechnology globally.

5. Conclusions

The extraordinary advances in life sciences, supported by digitalisation and AI, and the potential of solutions based on biology for solving societal issues make biotechnology and biomanufacturing one of the most promising technological areas of this century. They can help the EU to modernise its primary sector and industry, boost circularity and be more competitive and resilient, provide better healthcare to our citizens and succeed in its green transition.

A more coordinated approach for biotechnology and biomanufacturing policies will help realise their full potential. Strengthening our biotechnology and biomanufacturing competitiveness requires measures in the regulatory, industrial, economic and social dimensions. This includes significant investment in infrastructure and know-how and ensuring that it can reap the benefits of the EU single market.


The Commission will continue to follow-up and strengthen the EU level framework along the main actions:

- Action 1: Simplified regulatory framework and faster access to market: to prepare for this the Commission will launch a study analysing how the legislation that applies to biotech and biomanufacturing could be further streamlined across EU policies, exploring targeted simplifications to the regulatory framework, including for faster approval and bringing to the market. The study will be finalised by mid-2025 and could lay the foundations for a possible EU Biotech Act.

- Action 2: Better support for scale-up and ease of navigating regulations: the Commission will 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 end of 2024.

- Action 3: Use of AI and generative AI: the Commission will support structured exchanges with stakeholders to accelerate the uptake of AI, and in particular Generative AI, in biotech and biomanufacturing (in the context of GenAI4EU). The Commission will also raise awareness of facilitated access to the EuroHPC supercomputers for AI startups and the science and innovation community, in the course of 2024.

- Action 4: Encourage more private investments: in order to remove obstacles to investments, the Commission will complete a study to identify barriers and ways to support the consolidation of investment funds, stock exchanges and post-trading infrastructure, by mid-2025.

- Action 5: More public investments to encourage private investments in the sector: 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.

- Action 6: Enable fair comparison with fossil-based products: the Commission will further develop methodologies to ensure a fair comparison between fossil-based and bio-based products, in 2025. This will include reviewing the Product Environmental Footprint (PEF) to assess the environmental impact of products.

- Action 7: Bigger market for biotechnology and biomanufacturing: the Commission will deepen cooperation with international partners, such as the US, on biotechnology research, under the Science and Technology Agreements, by end 2024.

- Action 8: The Commission will review the EU Bioeconomy Strategy by end 2025. The review will take into account the current societal, demographic and environmental challenges, reinforcing the bioeconomy’s industrial dimension and its links to biotechnology and biomanufacturing to contribute to a stronger EU economy.


1 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 biotechnologies are geared towards various application areas, being the main ones medical and pharmaceutical (“red” biotechnology), agri-food (“green” biotechnology), and industrial and environmental (“white” biotechnology), with the marine biotechnology (so-called “blue”) gaining increased attention.

2 The use and conversion of biotechnology and biological resources into chemicals, products and energy.

3 Commission Recommendation (EU) 2023/2113 of 3 October 2023 on critical technology areas for the EU’s economic security for further risk assessment with Member States.

4 Proposal for a Regulation of the European Parliament and the Council establishing the Strategic Technologies for Europe Platform (‘STEP’) and amending Directive 2003/87/EC, Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/24, COM/2023/335 final.

5 With the publication of their “Bold goals for US biotechnology and biomanufacturing” report, the US has defined an industrial strategy for biotechnology and biomanufacturing, setting goals in five fields: climate, food and agriculture, supply chains, health and cross-cutting. China has also identified biotechnology as a key sector in its Made in China 2025 strategy. India, which is growing robustly in biotechnology, has unveiled a Biotechnology strategy as part of its own “Make in India” campaign, and the UK, with its “Life Science Strategy”, intends to give a new push to its biotechnology sector.

6 In the EU, the latest strategy focusing exclusively on biotechnology dates back to 2002: Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions, Life sciences and biotechnology - A Strategy for Europe, 2002/C 55/03.

7 Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions, Long-term competitiveness of the EU: looking beyond 2030, COM(2023) 168 final.

8 https://www.biospace.com/article/biotechnology-market-size-to-worth-around-us-3-44-trillion-by-2030/

9 https://www.statista.com/statistics/1246614/top-countries-share-of-global-biotech-value/

10 https://www.oecd.org/innovation/inno/keybiotechnologyindicators.htm

11 Such as gene editing, synthetic biology, bioprinting and bioinformatics.

12 EU27 adjusted values, EuropaBio study: “Measuring the economic footprint of the biotechnology industry in Europe”, December, 2020, https://www.europabio.org/wp-content/uploads/2021/02/201208_WifOR_EuropaBIO_Economic_Impact_Biotech_FINAL.pdf

13 Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions: “Advanced Materials for Industrial Leadership”, COM(2024) 98 final.

14 Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions “Addressing medicines shortages in the EU”, COM(2023) 672 final.

15 Examples of biotechnologies used in the forestry sector more commonly involve genomic tools to identify networks of genes that produce the most robust phenotypes for specific environmental conditions, with proposed benefits including increased fire resistance in trees and assisting trees to better adapt to changing climates.

16 Towards a Strong and Sustainable EU Algae Sector, COM(2022) 592 final.

17 PFS has been developed by Pharem Biotech, with the support of Horizon 2020.

18 Stora Enso: from trees to batteries: https://www.storaenso.com/en/products/lignin/lignode

19 Lignin is a type of polymer found in the cell of terrestrial plants, from 20% to 30% of a tree composition and it can be a component for a broad range of innovative products.

20 https://renewable-carbon.eu/publications/product/the-renewable-carbon-initiatives-carbon-flows-report-pdf/

21 World University Rankings 2022 by subject: life sciences | Times Higher Education (THE)

22 “CWTS Leiden Ranking 2022,” CWTS Leiden Ranking, accessed October 2022.

23 EU Industrial R&D Investment Scoreboard (2023), p. 50, Table 17 as well as Section 3.2.2 Health industries. A similar, albeit less pronounced US dominance is observed for the (non-biotech) pharmaceutical sector.

24 See https://www.nature.com/nature-index/institution-outputs/generate/all/global/all (key words: region: “global”, sector: “all”; subject or journal group: biological sciences).

25 Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Europe’s net-zero technology products manufacturing ecosystem (Net Zero Industry Act), COM(2023) 161 final.

26 This is one of the three EU headline targets for 2030 of the European Pillar of Social Rights Action Plan. https://op.europa.eu/webpub/empl/european-pillar-of-social-rights/en/

27 depending on the projected demand scenarios

28 “The European biomass puzzle – Challenges, opportunities and trade-offs around biomass production and use in the EU”: https://www.eea.europa.eu/en/newsroom/news/biomass-in-europe

29 IP5 includes: the European Patent Office (EPO), the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the US Patent and Trademark Office (USPTO) and the National Intellectual Property Administration of People’s Republic of China (NIPA).

30 Grassano, N., Napolitano, N., et al. (2024). Exploring the global landscape of biotech Innovation: preliminary insights from patent analysis. Luxembourg: Publications Office of the European Union (forthcoming).

31 Research Infrastructures are facilities that provide resources and services for research communities to conduct research and foster innovation. They include major scientific equipment or sets of instruments, collections, archives or scientific data, computing systems and communication networks.

32 Technology infrastructures are facilities, equipment, capabilities and support services where industrial players can find support to commercialise new products, processes and services, in full compliance with EU regulations.

33 Technology Centres are public or private organisations carrying out applied research and close-to-market innovation. Technology Centres typically provide the following services to SMEs: access to technology expertise and facilities for validation, demonstration, proof of concept / lab testing, prototype development and testing, pilot production and demonstration/ pilot lines / pre-series, product validation / certification.

34 Technology Centre Mapping tool launched by the Commission through the European Monitor of Industrial Ecosystems (EMI) project: https://monitor-industrial-ecosystems.ec.europa.eu/technology-centre/mapping.

35 S3 CoP Observatory (europa.eu): https://ec.europa.eu/regional_policy/assets/s3-observatory/index_en.html

36 IBISBA provides a single access point to researchers from academia and industry to integrated services for end-to-end bioprocess development (e.g., process optimization, data services, analytics or protein discovery and engineering).

37 This is a result of a collaboration between the European Molecular Biology Laboratory and Deep Mind.

38 Commission launches AI innovation package: https://ec.europa.eu/commission/presscorner/detail/en/ip_24_383

39 European '1+ Million Genomes' Initiative: https://digital-strategy.ec.europa.eu/en/policies/1-million-genomes

40 European Virtual Human Twins Initiative: https://digital-strategy.ec.europa.eu/en/policies/virtual-human-twins

41 Such as 1+ Million Genomes Initiative; European Cancer Imaging Initiative: https://digital-strategy.ec.europa.eu/en/policies/cancer-imaging

42 Any future sustainability criteria for bio-based feedstock beyond energy should be consistent with the sustainability criteria for energy products included in the recast Renewable Energy Directive 2018/2001.

43 Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions, Towards an ambitious Industrial Carbon Management for the EU, COM(2024) 62 final.

44 Intellectual property: harmonised EU patent rules: https://ec.europa.eu/commission/presscorner/detail/en/ip_23_2454

45 One possible question would be the possible generalisation to non-medical biotech of approaches under the Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment, OJ L 458, 22.12.2021, p. 1.

46 WiFOR Institute (2020), Measuring the Economic Footprint of Biotechnology in Europe: https://www.wifor.com/uploads/2021/03/201215_WifOR_EuropaBIO_Economic_Impact_Biotech_FINAL.pdf

47https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en

48 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 provides the overall framework on ATMPs.

49 The hospital exemption allows for the use of an ATMP without a central marketing authorization. The ATMP should be prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient.

50 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC 2

51 Actions include methodology guidance, improving data analytics and the creation of a Union level group of ethics committees enabling cooperation to work towards alignment of national requirements.

52 Projects co-funded by the EU (europa.eu): https://kohesio.ec.europa.eu/en/projects

53 Under State aid rules, the Risk Finance Guidelines, the General Block Exemption Regulation (Article 21 on risk finance aid) and the research and development and innovation (R&D&I) framework provide ample opportunities for financial support to biotechnology and biomanufacturing.

54 https://pact-for-skills.ec.europa.eu/about/industrial-ecosystems-and-partnerships/health_en, https://pact-for-skills.ec.europa.eu/about/industrial-ecosystems-and-partnerships/agri-food_en

55 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and The Committee of the Regions: Labour and skills shortages in the EU: an action plan, COM(2024) 131 final.

56 Proposal for a Regulation of the European Parliament and of the Council establishing an EU Talent Pool, COM(2023) 716 final.

57 Microbiomes are defined as complex microbial communities from various environments and ecosystems such as soils, marine, gut etc.

58 EU Mission: A Soil Deal for Europe: https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/eu-missions-horizon-europe/soil-deal-europe_en

59 One of the five flagship of the European Commission Communication “New European Innovation Agenda” (NEIA), COM(2022) 332 final

60 These cluster organisations are mapped on the European Cluster Collaboration Platform: https://reporting.clustercollaboration.eu/industry .

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