report parliamentary committee draft, 21 March 2025
On the future of the EU biotechnology and biomanufacturing sector: leveraging research, boosting innovation and enhancing competitiveness
Document ITRE-PR-768143 · (2025/2008(INI))
Committee on Industry, Research and Energy · Rapporteur: Hildegard Bentele
AI:In short
This draft report on the future of the EU biotechnology and biomanufacturing sector calls for an EU biotech act, streamlined authorisation, harmonised rules, and better funding and coordination to boost competitiveness. It stresses the need for regulatory sandboxes, IP protection, feedstock supply, lower energy prices, skilled workforce, and integration with digital and AI strategies.
Position. The rapporteur proposes a resolution calling for an EU biotech act, streamlined authorisation, better coordination, and increased funding to boost the sector's competitiveness.
Key points
- Asks that the EU biotech act be accompanied by impact and cost assessments and a Regulatory Scrutiny Board assessment, respecting 'one in, one out'.
- Recommends streamlining initiatives and creating a single coordination body, such as a 'Chief Biotechnology Officer', in the Commission.
- Calls for a report on implementation of current legislation, sharing study findings, and a biotechnology omnibus to simplify requirements.
- Calls for streamlined and simplified authorisation procedures, maintaining risk-proportionate and science-based approach, especially in agency reviews.
- Calls for harmonised IP rules, a common clinical trials framework using real-world evidence, and a Commission report on improvements.
- Recommends using next-generation regulatory sandboxes to trial emerging applications in a controlled but flexible environment.
- Underlines the need to account for bio-based product specificities in chemical and environmental legislation for petrochemical products.
- Asks the Commission to examine definitions so that bio-based projects are not denied funding by the European Investment Bank's Paris alignment interpretation.
- Underlines that bio-based products' CO2 reduction benefits must be reflected in life cycle assessments, consumer info, and public procurement.
- Points out early tastings are important for rapid commercialisation of food biotechnology.
- Underlines that biosecurity risks must be addressed with innovation, ensuring responsible access to synthetic biology tools and genetic editing.
- Calls for monitoring feedstock supply risks, improving knowledge transfer, lowering energy prices, developing skills, completing capital markets union, and strengthening investment instruments.
Who is affected
- EU biotechnology and biomanufacturing companies, especially start-ups and SMEs, would benefit from streamlined procedures and better funding.
- The European Commission would be tasked with presenting reports, assessments, and coordinating bodies.
- The European Investment Bank may need to adjust its funding criteria for bio-based projects.
Figures and deadlines
Legal basis. Articles 9, 151, 152, 153(1) and (2), 173 and 179 of the Treaty on the Functioning of the European Union
Written by AI from the full text · every figure comes from the text · ¶ opens the paragraph · 4 Sept 2026 · Report a problem
Full text
Motion for a european parliament resolution 41 paragraphs
(2025/2008(INI))
The European Parliament,
–having regard to the Treaty on the Functioning of the European Union, in particular Articles 9, 151, 152, 153(1) and (2) thereof, as well as Articles 173 and 179 thereof, which concern EU industrial policy and research and refer to, among other things, the competitiveness of the Union’s industry and the strengthening of the Union’s scientific and technological bases,
–having regard to the Treaty on European Union, in particular Article 5(3) thereof and Protocol No 2 thereof on the application of the principles of subsidiarity and proportionality,
–having regard to the Commission communication of 20 March 2024 entitled ‘Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU’ (COM(2024)0137),
–having regard to the report by Mario Draghi of 9 September 2024 entitled ‘The future of European competitiveness: A competitiveness strategy for Europe’,
–having regard to the Commission communication of 29 January 2025 entitled ‘A Competitiveness Compass for the EU’ (COM(2025)0030),
–having regard to the Commission communication of 26 February 2025 entitled ‘The Clean Industrial Deal: A joint roadmap for competitiveness and decarbonisation’ (COM(2025)0085),
–having regard to Rule 55 and Rule 148(2) of its Rules of Procedure,
–having regard to the report of the Committee on Industry, Research and Energy (A10-0000/2025),
A.whereas the EU biotechnology and biomanufacturing sector has been recognised as one of ten strategic technology sectors for Europe’s competitiveness, economic security, and sustainability; whereas the sector is characterised by very high productivity and delivers globally competitive, cutting-edge solutions in healthcare, industrial transformation, sustainable biomanufacturing, and food security; whereas the biotechnology and biomanufacturing sector still faces regulatory and financial obstacles and an incomplete internal market; whereas the Commission is expected to present an EU biotech act;
B.whereas the EU is a global leader in research and biomanufacturing capacity, yet lacks a sufficiently coordinated policy framework to efficiently scale up innovation, attract investments and commercialise new technologies; whereas lengthy authorisation procedures drive project developers out of the EU and hinder industrial deployment and growth;
Read the rest (29 paragraphs)
C.whereas Europe’s biotechnology and biomanufacturing investment and venture capital ecosystem remains fragmented; whereas high energy prices and a lack of available key feedstock are limiting the ability of start-ups and other small and medium-sized enterprises (SMEs) to scale up; whereas biomanufacturing capacity and supply chain resilience are essential to reduce dependence on non-EU actors;
D.whereas current EU regulatory frameworks for biotechnology and biomanufacturing are inconsistent across sectors, creating legal uncertainty and slowing market access for innovative solutions; whereas regulatory sandboxes should be expanded to ensure that emerging technologies have a clear development pathway; whereas new EU-wide regulation in the form of an EU biotech act should be duly justified using examples of concrete gaps and shortcomings in current legislation and implementation, focusing on the specificities of the industry;
Criteria for a comprehensive EU biotech act
1.Underlines Parliament’s commitment to the ‘one in, one out’ and simplification principles; asks that the EU biotech act be accompanied by an impact and cost assessment, as well as a comprehensive assessment by the Regulatory Scrutiny Board;
2.Recommends streamlining and harmonising upcoming and current initiatives relating to biotechnology and biomanufacturing, such as the review of the EU’s bioeconomy strategy and the forthcoming life sciences strategy, with the objective of strengthening the industry through a clear industrial and research and development (R&D) competence; calls for the creation of a single coordination body, such as a ‘Chief Biotechnology Officer’, in the Commission;
3.Calls on the Commission to present a report on the implementation of current legislation in the field of biotechnology and biomanufacturing, including identifying potential gaps and regulatory barriers hampering the growth of the industry; urges the Commission to share with Parliament the preliminary findings of its study on regulatory burden and the potential need to change legislation related to biotechnology and biomanufacturing; calls for a biotechnology omnibus that simplifies current requirements for the sector across regulatory frameworks;
4.Calls on the Commission to streamline and simplify authorisation procedures for biotechnology materials and manufacturing, while maintaining a risk proportionate and science-based approach, in particular in the context of the upcoming review of EU agencies such as the European Food Safety Authority and the European Chemicals Agency;
5.Recalls that harmonised and internationally competitive intellectual property protection rules for biotechnology and biomanufacturing patents are essential for the development of the industry; calls for a common clinical trials framework that allows for the use of real-world evidence for biotechnology therapies; asks the Commission to present the current situation in this regard, as well as potential improvements;
6.Recommends using the next generation of regulatory sandboxes to assess the specific impact and possibilities of emerging biotechnology and biomanufacturing applications, ensuring that new technologies can be trialled in a controlled but flexible regulatory environment;
The need to promote the advantages and specificities of the biotechnology and biomanufacturing industry
7.Underlines the need to account for the specificities of bio-based products and processes in the context of chemical and environmental legislation for petrochemical products;
8.Is concerned that the European Investment Bank’s interpretation of the sustainability criteria under the Paris alignment framework may result in access to funding for bio-based materials and projects being denied; asks the Commission to examine definitions accordingly and enforce biotechnology- and biomanufacturing-friendly interpretations;
9.Underlines the benefit and contribution of bio-based products and processes to the EU’s CO2 reduction objectives, which need to be reflected in respective life cycle assessments, information for consumers and public procurement;
10.Points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite;
11.Underlines that biosecurity risks must be addressed in conjunction with biotechnology and biomanufacturing innovation, ensuring responsible access to and use of synthetic biology tools, genetic editing technologies and biological materials;
Horizontal issues
12.Underlines the importance for supply chain security of having a sufficient feedstock supply for biotechnology and biomanufacturing companies; calls for potential risks to be monitored while safeguarding company-sensitive data and the functioning of the internal market;
13.Stresses the need to improve the transfer of knowledge and technology between academia and industry to ensure that EU-funded biotechnology and biomanufacturing research leads to commercial applications and industrial deployment;
14.Stresses the need to decrease energy prices and facilitate the process of validating large-scale industrial plants with large bioreactors;
15.Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills;
16.Calls for the urgent completion of the capital markets union to attract institutional investors to the biotechnology and biomanufacturing industry, including venture capital, pension funds and private equity; highlights that cross-border investment barriers need to be reduced to facilitate investment in biotechnology and biomanufacturing scale-ups;
17.Notes that public-private partnerships and mission-driven EU investment strategies, such as the Circular Bio-based Europe Joint Undertaking, are essential for de-risking biotechnology and biomanufacturing innovation; urges that EU investment instruments such as the InvestEU programme be strengthened to support high-risk biotechnology and biomanufacturing projects; calls for a dedicated SME funding initiative to support biotechnology and biomanufacturing start-ups and scale-ups;
Future-proof research and innovation
18.Highlights the fact that European public systems for R&D funding remain complex and insufficiently coordinated, resulting in duplications and inefficiencies; calls for an EU-wide approach to coordinate public investment in R&D for biotechnology and biomanufacturing in order to close the excellence gap;
19.Reiterates the call to double the EU’s research budget and to reach the target of 3 % of European gross domestic product being devoted to R&D by 2030; calls for the mainstreaming of the ‘innovation principle’ as a cross-sectorial principle for all EU funding;
20.Notes the growing role of synthetic biology, bioinformatics and game-changing AI-driven biotechnology research; calls on the Commission to integrate biotechnology and biomanufacturing innovation into the EU digital and AI strategies;
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21.Instructs its President to forward this resolution to the Council and the Commission.
Explanatory statement 2 paragraphs
To keep our high standard of living, our safety and future viability, Europe needs to be at the forefront of technological innovation and the EU must become world leading in research and innovation. These are the guiding principles to this report. Europe cannot succeed with its ambitions on competitiveness, decarbonisation and economic resilience without acknowledging the crucial role played by the EU’s biotechnology and biomanufacturing sector. This fascinating new science and technology transcends different industrial sectors and is based on the use of and work with living organisms, of the force of nature. It does not only enable ground-breaking innovations and manufacturing processes, it is of strategic importance in several different areas such as sustainability, economic security, food security and public health.
The growth potential of the biotechnology and biomanufacturing industry is immense and the productivity of the sector very high. The aim of this report is to shed light on the existing bottlenecks and to provide recommendations to support the industry to reach its full potential. As European lawmakers, we insist on the fact new regulation needs to be duly justified and globally connectable. The biotechnology and biomanufacturing sector encounters the general problems of other new sectors like the lack of transfer of academic knowledge to the market, insufficient access to capital and incoherent, outdated or inappropriate regulation and feedstock security. The biggest hurdle is the length of authorisation procedures in the EU giving away early-adapter advantages to competitors. There is high need to take into account the specificities of the sector also with regard to security and citizen involvement, biotechnology in terms of regulation presents a showcase for further testing regulatory sandboxes. To ensure full focus, better coordination and detectable improvements for European biotechnology and biomanufacturing companies, the creation of a Chief Biotechnology Officer in the European Commission is recommended.