Changes from report parliamentary committee draft to plenary report

MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION

on the future of the EU biotechnology and biomanufacturing sector: leveraging research, boosting innovation and enhancing competitiveness

(2025/2008(INI))

The European Parliament,

Changed– having regard to the Treaty on the Functioning of the European Union,Union (TFEU), 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,

Changed– having regard to the Treaty on European Union, in particular Article 5(3) thereof and Protocol No 2 thereofthereto 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),

Changed– having regard to the report by Mario Draghi of 9 September 2024 entitled ‘The future of European competitiveness: A competitiveness strategy for Europe’,competitiveness’,

– 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),

Added– having regard to the Commission communication of 11 December 2019 entitled ‘The European Green Deal’ (COM(2019)0640),

Added– having regard to the report by Enrico Letta of 10 April 2024 entitled ‘Much more than a market’,

Added– having regard to the Commission communication of 19 February 2025 entitled ‘A Vision for Agriculture and Food – Shaping together an attractive farming and agri-food sector for future generations’ (COM(2025)0075),

– having regard to Rule 55 and Rule 148(2) of its Rules of Procedure,

Changed– having regard to the report of the Committee on Industry, Research and Energy (A10-0000/2025),(A10-0123/2025),

Change 1

ChangedA. whereas the EU biotechnology and biomanufacturing sector has been recognised as one of ten10 strategic technology sectors for Europe’s competitiveness, economic security,security and sustainability; whereas the sector is characterised by very high productivityproductivity, growth and employment, and delivers globally competitive, cutting-edge solutions in healthcare, life sciences, industrial production and transformation, sustainable biomanufacturing, energy and food security; whereas biotechnology and biomanufacturing are important enablers of the bioeconomy at large; whereas biotechnology and biomanufacturing can help enhance the EU’s strategic autonomy, resilience and circularity by reducing industry’s dependency on fossil-based input and other external dependencies in various sectors; 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, an updated EU bioeconomy strategy, an EU life sciences strategy, an EU innovation act and an EU circular economy act;

Change 2

RemovedB. 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;

AddedB. whereas according to the Organisation for Economic Co-operation and Development (OECD), biotechnology is defined as the application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services; whereas biomanufacturing is not clearly defined and the Commission should therefore propose such a definition; whereas a definition of biomanufacturing should be future-proof, open to scientific and technological developments, and technology neutral, so as to broadly encompass the use of biotechnology or other technologies for the production of bio-based material products and solutions including, but not limited to, chemical, mechanical or thermal processes;

RemovedC. 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;

AddedC. whereas the biotech and biomanufacturing industries have led the development and deployment of breakthrough innovations in healthcare, such as mRNA-based vaccines; whereas biotechnology processes can be used to manufacture active pharmaceutical ingredients and key manufacturing inputs for medicines;

RemovedD. 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;

AddedD. whereas the COVID-19 pandemic highlighted the importance of having robust raw material value chains and manufacturing capabilities within Europe, to ensure security of supply of critical products and to mitigate shortages, for example of essential medicines;

AddedE. whereas artificial intelligence (AI) can help drive biotechnology innovation – e.g. in personalised medicine and drug discovery – resulting in health and environmental benefits; whereas the use of AI in biotechnology can also present ethical challenges and risks, related to the protection of private data, which need to be addressed in order to maintain public trust and acceptance;

AddedF. whereas biotechnology is applied in various aspects of animal and plant-based agriculture and also indirectly, through its use in activities such as waste management;

AddedG. whereas biotechnology can strengthen the resilience of forests and, in the case of biomanufacturing, the forest sector can offer sustainably produced, renewable and recyclable raw materials that can be used in high-value innovative products, materials and applications;

AddedH. whereas the EU is a global leader in research and biomanufacturing capacity, yet its potential remains unexploited due to the lack of a sufficiently coordinated policy framework that enables the efficient scaling up of innovation, the attraction of investment and the commercialisation of new technologies; whereas the ‘one in, one out’ approach ensures that all burdens introduced by Commission initiatives are considered, and administrative burdens are offset by removing burdens of equivalent value in the same policy area at EU or Member State level; whereas Parliament has called for the EU’s research budget to be doubled; whereas EU private investment in research, development and innovation is lagging behind other major economies; whereas promoting investment in pioneering demo and commercial production plants can accelerate the commercialisation of EU innovation in the bio-based industries;

AddedI. whereas urgent, coherent and consistent action needs to be taken during the next few years to make the EU a world leader in biotechnology, biomanufacturing and life sciences effecting a bold level of change, in accordance with due process and supported by competitiveness checks and adequate funding;

AddedJ. whereas lengthy and complex authorisation procedures, particularly concerning approval times, represent a competitive disadvantage for EU operators and drive project developers out of the EU, and hinder industrial deployment and growth;

AddedK. whereas current EU regulatory frameworks do not cater precisely to the specificities of bio-based products; whereas the existing regulatory authorisation processes for biotech products needs to be urgently addressed to ensure that the EU remains globally competitive; whereas an effective regulatory framework for conducting clinical research is essential for the competitiveness of the most innovation-intensive aspects of the EU’s pharmaceutical and biotechnology sectors; whereas the Commission should take account of the regulatory frameworks of non-EU countries leading in the biotechnology and biomanufacturing sector, in the context of existing and future EU legislation covering the industry, to ensure compatibility without lowering existing EU safety and environmental standards;

AddedL. whereas the EU’s biotechnology and biomanufacturing investment and venture capital ecosystem remains fragmented; whereas high energy prices, regulatory burdens, barriers, and a lack of available key feedstock, raw materials and components are limiting the ability of start-ups and other small and medium-sized enterprises (SMEs) to scale up, and limit large-scale deployment; whereas EU biomanufacturing capacity and supply chain resilience, including the availability of feedstock, are essential to reduce dependence on non-EU actors; whereas effective global supply chains – including strategic partnerships with reliable global actors – are also important to secure stable access to critical resources, avoid supply disruptions and foster continuous innovation in essential technologies;

AddedM. whereas bio-based feedstocks, such as sustainably sourced biomass, recycled waste and CO2 captured from biogenic sources, could be used as alternative feedstocks for the manufacturing of, for example, polymers, plastics, solvents, paints, detergents, cosmetics and pharmaceuticals, thereby contributing to EU emission reduction, resource efficiency and strategic autonomy; whereas the EU could further incentivise market demand and market uptake for sustainable bio-based products and materials;

AddedN. whereas it is vital to increase the use of sustainable bio-based raw materials as part of the means of reaching the EU’s 2050 climate targets; whereas biotechnology has the potential to transform the refinery and chemical industry towards biomanufacturing, thereby reducing greenhouse gas emissions, in line with the EU’s climate objectives;

AddedO. whereas biotechnology and biomanufacturing are regulated across many different regulatory frameworks; whereas current EU regulatory frameworks for biotechnology and biomanufacturing are inconsistent across sectors, creating legal uncertainty and slowing market access for innovative solutions; whereas the lengthy authorisation processes, particularly concerning approval times, need to be urgently addressed and improved, while maintaining a risk- and science-based approach, to compete with corresponding time frames outside the EU; whereas the use of 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 based on examples of concrete gaps and shortcomings in current legislation and implementation, focusing on the specificities of the industry;

AddedP. whereas a coherent, robust and future-proof intellectual property (IP) framework is essential, ideally resulting in economic, environmental and societal benefits;

AddedQ. whereas public awareness in the EU of biotechnology and biomanufactured products should be further strengthened, in order to boost public acceptance; whereas the ethical aspects of biotechnology should be considered; whereas stakeholder consultation plays a crucial role in shaping responsible and ethical biotechnology policies; whereas civil society can play an essential role in ensuring public trust;

AddedR. whereas the engineering of DNA and organisms is increasingly carried out in automated biofoundries, which produce a wealth of data and improved designs and knowledge of biological functions;

AddedS. whereas the EU’s regulatory framework needs to adequately address evolving risks, opportunities and responsibilities associated with the handling, trade and synthesis of biological material, particularly in the context of synthetic biology; whereas existing biosecurity gaps need to be addressed by the EU and through international cooperation;

Criteria for a comprehensive EU biotech act

Change 3

Removed1. 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;

Added1. Emphasises the growth potential of the European biotechnology and biomanufacturing sector and the need for the EU to remain world-leading in this field; underlines the commitment to the principles of better regulation and lawmaking, simplification and administrative burden reduction; underlines that the simplification of EU legislation must not endanger any of the fundamental rights of citizens, workers and businesses or risk regulatory uncertainty; believes that any simplification proposal should not be rushed and proposed without proper consideration, consultation and impact assessments; therefore asks the Commission, if it proposes a new EU-wide regulation in the form of an EU biotech act, to address concrete gaps and shortcomings in current legislation and implementation, and to present legislation that can be revised, simplified, streamlined, repealed and which reduces bureaucratic burdens, focusing on the specificities of the industry and maintaining relevant safety and security standards; asks that an EU biotech act adopt a comprehensive cross-sectoral scope and that it be accompanied by an impact and cost assessment, competitiveness checks as well as a comprehensive assessment by the Regulatory Scrutiny Board, taking due consideration of the impact on SMEs, start-ups and scale-ups, as well as the interaction with other relevant legislative and non-legislative initiatives, including proposals currently undergoing the co-legislative procedure;

Removed2. 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;

Added2. Recalls that according to the OECD, biotechnology is defined as the application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services; notes, however, that biomanufacturing is not clearly defined and calls on the Commission to propose such a definition;

Removed3. 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;

Added3. Recommends streamlining and harmonising existing and upcoming initiatives relating to biotechnology and biomanufacturing, with the objective of strengthening the biotechnology and biomanufacturing industry through clear industrial and research and development (R & D) competences;

Removed4. 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;

Added4. Urges the Commission to ensure coherence and consistency across all initiatives and legislative measures that may affect biotechnology and biomanufacturing innovations and companies, especially start-ups and scale-ups;

Removed5. 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;

Added5. Calls on the Commission to ensure that any future relevant legislative initiatives have a broad enough scope to capture the width of the biotechnology and biomanufacturing industry and its full range of applications; recommends facilitating a fast and efficient uptake of biotechnology and biomanufacturing through clear regulatory frameworks;

Removed6. 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;

Added6. Calls on the Commission to implement measures within its structures in order to ensure coordination, coherence and complementarity across its relevant directorates-general, and to enable more efficient scale-up and commercialisation of research, development and innovation results; highlights the importance of efforts to improve policy coherence and coordination at national level;

Added7. Calls on the Commission to take account of regulatory frameworks of non-EU countries leading in the biotechnology and biomanufacturing sector, in the context of existing and future EU legislation covering the industry, to ensure compatibility, where possible and without compromising consumer safety, and a level playing field for EU biotech companies competing internationally, and to learn from best practices from outside the EU without lowering existing EU standards;

Added8. 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 industries applying these technologies and manufacturing processes, including barriers to improving the EU’s self-sufficiency in key feedstocks, raw materials and components; recalls the precautionary principle laid down in Article 191 TFEU; urges the Commission to share with Parliament the preliminary findings of its study on regulatory burden, in this regard, and the potential need to review legislation related to biotechnology and biomanufacturing; calls for a simplification of current requirements for the sector across regulatory frameworks to enable faster approval procedures and market access, while maintaining a risk- and science-based approach and avoiding regulatory uncertainty;

Added9. Welcomes the recently launched Biotech and Biomanufacturing Hub; requests that the Commission provide further guidance to EU biotechnology and biomanufacturing companies and the Member States with regard to the Net-Zero Industry Act and the new Clean Industrial Deal in terms of permitting and financing, and to consider the creation of supporting hubs, in order to improve guidance and advice to companies navigating through the regulatory framework;

Added10. Calls on the Commission to urgently streamline, simplify and shorten the time required for authorisation procedures, particularly approval time frames, for biotechnology materials and products throughout their manufacturing- and life-cycles, and to facilitate the market uptake of bio-based solutions, including the provision of pre-authorisation guidance, while maintaining a risk- and science-based approach, particularly in the context of its regular review of EU agencies such as the European Food Safety Authority, the European Medicines Agency and the European Chemicals Agency; calls on the Commission to ensure that the relevant EU agencies are adequately resourced, to enhance their capacity for conducting authorisation procedures in a timely manner;

Added11. Calls on the Commission to consider the possibility of a simplified approvals procedure for biotechnology products that have already been approved by trusted regulatory bodies in like-minded countries with EU-equivalent standards;

Added12. Calls on the Commission to consider simplifying labelling practices, such as the use of QR codes, and ensure fair market conditions between biotechnology and other products, such as marketing and advertising, without compromising consumer safety or access to relevant consumer information;

Added13. Recalls that harmonised, predictable, future-proof and internationally competitive IP and data protection rules for biotechnology and biomanufacturing patents are essential for the development of the industry, resilient supply chains and sustainable economic growth; underlines the importance of improving IP protection rules by longer terms for patented technologies to strengthen the EU’s competitiveness, foster innovation and the EU’s strategic autonomy, protect cutting-edge technologies, reward long-term investments, and support high-risk research; considers that a coherent, robust and future-proof IP framework is essential; welcomes, in this regard, the EU’s recently established unitary patent system;

Added14. Calls for a common clinical trials framework with streamlined approval procedures across the Member States to minimise administrative burdens and delays, and which 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; calls for the swift implementation of the Clinical Trials Regulation and the use of the EU’s Clinical Trials Information System;

Added15. Underlines the strategic importance for the EU of a strong biotechnology ecosystem to support R & D, manufacturing, and patient access to innovative medicines; points out that biotechnology processes can be used to manufacture active pharmaceutical ingredients and key manufacturing inputs for both off-patent and innovative medicines;

Added16. Recommends using the next generation of regulatory sandboxes to assess the specific impacts and possibilities of emerging biotechnology and biomanufacturing applications, ensuring that new technologies can be trialled in a controlled but flexible and future-proof regulatory environment; stresses the importance of ensuring that EU policy takes account of technological and scientific developments to safeguard the EU’s global competitiveness;