Sittings · Document
Draft report (2025/2008(INI)) 2025-04-15
Future of the EU biotechnology and biomanufacturing sector: leveraging research, boosting innovation and enhancing competitiveness
Committee on Industry, Research and Energy
Amendment 1
Marcin Sypniewski
Motion for a resolution
Citation 1 a (new)
| Motion for a resolution | Amendment |
| – Having regard to Article 168(7) of the Treaty on the Functioning of the European Union, which establishes that the definition of health policy, including ethical considerations related to biology and medicine, remains within the exclusive competence of Member States; |
Or. en
Amendment 2
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Citation 1 a (new)
| Motion for a resolution | Amendment |
| – having regard to the Letta report on the Future of the Single Market. |
Or. en
Amendment 3
Morten Løkkegaard, Sigrid Friis, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Citation 1 b (new)
| Motion for a resolution | Amendment |
| – having regard to the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee And The Committee Of The Regions “A Vision For Agriculture And Food Shaping Together An Attractive Farming And Agri-Food Sector For Future Generations” (COM/2025/75 final) |
Or. en
Amendment 4
Marcin Sypniewski
Motion for a resolution
Citation 1 b (new)
| Motion for a resolution | Amendment |
| – Having regard to Articles 2 and 3 of the Charter of Fundamental Rights of the European Union, which guarantee the right to life and the right to respect for physical and mental integrity, including in the fields of biology and medicine, particularly the free and informed consent of the person concerned; |
Or. en
Amendment 5
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia, Pascale Piera
Motion for a resolution
Citation 2 a (new)
| Motion for a resolution | Amendment |
| – having regard to the UN Universal Declaration on the Human Genome and Human Rights; |
Or. en
Amendment 6
Margarita de la Pisa Carrión, Julie Rechagneux, Paolo Borchia
Motion for a resolution
Citation 4 b (new)
| Motion for a resolution | Amendment |
| – having regard to the report by Enrico Letta of 18 April 2024 entitled ‘Much More Than a Market’, |
Or. en
Amendment 7
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Citation 6 a (new)
| Motion for a resolution | Amendment |
| – having regard to Directive (EU) 2023/2413 of the European Parliament and of the Council of 18 October 2023 amending Directive (EU) 2018/2001, Regulation (EU) 2018/1999 and Directive 98/70/EC as regards the promotion of energy from renewable sources, and repealing Council Directive (EU) 2015/6525 (the Renewable Energy Directive), |
Or. en
Amendment 8
Sigrid Friis
Motion for a resolution
Citation 6 a (new)
| Motion for a resolution | Amendment |
| – - having regard to the Commission communication of 11 December 2019 on the European Green Deal (COM(2019)0640), |
Or. en
Amendment 9
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Citation 6 b (new)
| Motion for a resolution | Amendment |
| – having regard to Directive (EU) 2024/825 of the European Parliament and of the Council of 28 February 2024 amending Directives 2005/29/EC and 2011/83/EU as regards empowering consumers for the green transition through better protection against unfair practices and through better information, |
Or. en
Amendment 10
Sigrid Friis
Motion for a resolution
Citation 6 b (new)
| Motion for a resolution | Amendment |
| – - having regard to the report by the the Strategic Dialogue on the future of EU agriculture of 4 September 2024 entitled ‘Strategic Dialogue of the Future of EU Agriculture: A shared prospect for farming and food in Europe’, |
Or. en
Amendment 11
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Citation 8 a (new)
| Motion for a resolution | Amendment |
| – having regard to the Communication from the Commission to the European Parliament, the Council, the European Economic And Social Committee And The Committee Of The Regions “A Vision For Agriculture And Food: Shaping together an attractive farming and agri-food sector for future generations” COM(2025)75 final |
Or. en
Amendment 12
Anthony Smith
Motion for a resolution
Citation 8 a (new)
| Motion for a resolution | Amendment |
| – having regard to Occupational Safety and Health Convention, 1981 (No. 155) and the Promotional Framework for Occupational Safety and Health Convention, 2006 (No. 187) of the International Labour Organisation |
Or. en
Amendment 13
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Citation 8 b (new)
| Motion for a resolution | Amendment |
| – having regard to the Communication from the Commission to the European Parliament, the Council, the European Economic And Social Committee And The Committee Of The Regions "The Clean Industrial Deal: A joint roadmap for competitiveness and decarbonisation" COM(2025)85 final |
Or. en
Amendment 14
Anthony Smith
Motion for a resolution
Citation 8 b (new)
| Motion for a resolution | Amendment |
| – having regard to Freedom of Association and Protection of the Right to Organise Convention, 1948 (No. 87) and Right to Organise and Collective Bargaining Convention, 1949 (No. 98) of the International Labour Organisation |
Or. en
Amendment 15
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Citation 8 c (new)
| Motion for a resolution | Amendment |
| – having regard to the Communication from the Commission to the European Parliament, the Council, the European Economic And Social Committee And The Committee Of The Regions "A Competitiveness Compass for the EU" COM(2025)30 final |
Or. en
Amendment 16
Anthony Smith
Motion for a resolution
Recital -A (new)
| Motion for a resolution | Amendment |
| -A. whereas biotechnology and biomanufacturing, while offering potential major breakthrough in many industrial fields, could raise significant health and ethical concerns; whereas the precautionary principle must be respected; |
Or. en
Amendment 17
Anthony Smith
Motion for a resolution
Recital -A a (new)
| Motion for a resolution | Amendment |
| -A a. whereas biotechnology and biomanufacturing pose the risk of commodification and privatization of nature and living things; whereas innovation in the sector must serve the needs of society and not the maximization of profits; whereas the research, development, and marketing of techniques or products that may pose ethical concerns, as well as the privatization of living things, must be subject to democratic debate involving the entirety of European civil society, including trade unions; |
Or. en
Amendment 18
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital A
| Motion for a resolution | Amendment |
| 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; | 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 biotechnology, according the definition by the OECD means 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; whereas biomanufacturing is not clearly defined, but could be understood as the use of biotechnology or other technologies, such as, mechanical, chemical or thermal processes to manufacture bio-based products; whereas biotechnology and biomanufacturing are important enablers for the bioeconomy at large; whereas the sector is characterised by very high, employment and productivity rates and delivers globally competitive, cutting-edge solutions in healthcare, industrial transformation, sustainable biomanufacturing, and food security; whereas biotechnology can help enhance the EU’s strategic autonomy, resilience and circularity by reducing industry’s dependency on fossil-based input and other external dependencies, including in the agri-food sector and contribute to EU’s food sovereignty and the competitiveness of the agriculture sector; 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 and an updated Bioeconomy Strategy; |
Or. en
Amendment 19
Morten Løkkegaard, Olivier Chastel, Christophe Grudler, Oihane Agirregoitia Martínez, Yvan Verougstraete, Katri Kulmuni
Motion for a resolution
Recital A
| Motion for a resolution | Amendment |
| 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; | A. whereas the European Parliament welcomes the upcoming European Biotech Act because 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, life sciences, industrial production and transformation, sustainable biomanufacturing, energy and food security; whereas biotechnology and biosolutions can help reduce EU's external dependencies; whereas the biotech and biomanufacturing sector still faces regulatory and financial obstacles, unfair market terms and incomplete internal market; whereas the Commission is expected to present an EU Biotech Act; |
Or. en
Amendment 20
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Recital A
| Motion for a resolution | Amendment |
| 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; | 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; whereas such innovation best succeed in the market when aligned with circularity principles, resource efficiency, and planetary boundaries; |
Or. en
Amendment 21
Sigrid Friis
Motion for a resolution
Recital A
| Motion for a resolution | Amendment |
| 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; | 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 biotechnology can help reduce EU's external dependencies including in the agri-food sector and contribute to EU’s food sovereignty; 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; |
Or. en
Amendment 22
Anthony Smith
Motion for a resolution
Recital A
| Motion for a resolution | Amendment |
| 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; | 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 lacks a coherent and enabling regulatory framework for the development of its full potential while ensuring the precautionary principles and democratic control ; whereas the Commission is expected to present an EU biotech act; |
Or. en
Amendment 23
Letizia Moratti
Motion for a resolution
Recital A
| Motion for a resolution | Amendment |
| 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; | 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 growth, employment, and 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; |
Or. en
Amendment 24
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia
Motion for a resolution
Recital A
| Motion for a resolution | Amendment |
| 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; | 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 internal market that is in development; whereas the Commission is expected to present an EU biotech act; |
Or. en
Amendment 25
Carlo Ciccioli
Motion for a resolution
Recital A
| Motion for a resolution | Amendment |
| 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; | 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, agriculture 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; |
Or. en
Amendment 26
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera
Motion for a resolution
Recital A
| Motion for a resolution | Amendment |
| 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; | 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, whereas the current framework does not include a legal definition of biotechnology and biomanufacturing that reflects the entirety of the production chain, the diversity of techniques involved, as well as the new opportunities opened up by scientific and technological advances; |
Or. en
Amendment 27
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital A a (new)
| Motion for a resolution | Amendment |
| A a. whereas the biotech and biomanufacturing industries have led the development and deployment of breakthrough innovations in healthcare, such as, mRNA-based vaccines; whereas biotechnolgoy processes can be used to manufacture active pharmaceutical ingredients and key manufacturing inputs for medicines; whereas biotech is already applied throughout the agri-food supply chain into various aspects of animal and plant-based agriculture and indirectly through its role in activities such as waste management; 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; whereas biobased feedstocks, such as sustainable biomass, recycled waste and co2 captured from biogenic sources could be used as alternative feedstocks for the manufacturing of polymers, plastics, solvents, paints, detergents, cosmetics and pharmaceuticals, contributing to emission reduction, resource efficiency and strategic autonomy; whereas the EU could further incentivise market demand and market uptake for sustainable biobased products and materials, for example, through lead markets, public procurement or minimum content requirements; |
Or. en
Amendment 28
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Recital A a (new)
| Motion for a resolution | Amendment |
| A a. whereas biotechnology may be defined as the application of scientific and technical principles to living organisms or their components with the aim of developing useful products or processes; whereas it encompasses fields such as genetics, microbiology, biochemistry and engineering, and is applied across multiple sectors, including health, agriculture and industry; |
Or. en
Amendment 29
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Recital A b (new)
| Motion for a resolution | Amendment |
| A b. whereas the manufacturing of biological products, as a specialised field within biotechnology, refers to the use of biological systems to produce biologically functional materials and products intended for various applications, notably in the pharmaceutical, agricultural and industrial sectors; whereas it encompasses processes such as cell culture, microbial fermentation, enzymatic synthesis, or the assembly of biological components into complex structures; whereas the manufacturing of biological products stems from advances in biotechnology, including the direct manipulation of genetic material, thereby paving the way for innovative applications in multiple domains; |
Or. en
Amendment 30
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Recital A c (new)
| Motion for a resolution | Amendment |
| A c. whereas the manufacturing of biological products requires significant investment in highly specialised infrastructures, such as biobanks, cell culture laboratories, biocompatible 3D printing platforms, bioreactors, automated and robotic control systems, advanced imaging and characterisation technologies, biological containment and biosafety devices, as well as certified production units for clinical and industrial use; |
Or. en
Amendment 31
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Recital A d (new)
| Motion for a resolution | Amendment |
| A d. whereas the manufacturing of biological products encompasses a range of techniques and applications requiring rigorous bioethical oversight; whereas these techniques include practices with significant ethical implications, such as the creation of human-animal chimeras, the precautionary use of certain genetically modified organisms, genetic enhancement, the use of human embryonic or pluripotent stem cells, synthetic gametes, as well as germline genome editing; whereas Member States may reserve the right to adopt stricter measures based on their sovereign bioethical choices; whereas such national choices, rooted in bioethics, should not be regarded as obstacles to the Union’s industrial development, nor as infringements upon the European Research Area; |
Or. en
Amendment 32
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Recital B
| Motion for a resolution | Amendment |
| 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; | 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; whereas the communication 'Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU' sets out a series of proposed actions, including the promotion of research and innovation, improved access to finance, stimulation of demand, simplification of the regulatory framework, and the strengthening of specialised skills; whereas the transition from fundamental research to applied innovation in the field of biotechnology and the manufacturing of biological products requires close cooperation between academic research, industrial actors, and public decision-makers; |
Or. en
Amendment 33
Carlo Ciccioli
Motion for a resolution
Recital B
| Motion for a resolution | Amendment |
| 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; | B. 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, investment attraction, market penetration and uptake of new technologies; whereas fragmentation is compounded by regulatory uncertainties, including inappropriate classification, which distort regulatory treatment and access to market; whereas urgent, coherent, and consistent action needs to be taken over the next few years to make Europe a world leader in biotechnology and life sciences with bold level of change, backed up with due process supported by competitiveness checks and adequate funding; |
Or. en
Amendment 34
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital B
| Motion for a resolution | Amendment |
| 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; | 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 the European Parliament has called to double the EU’s research budget; whereas European private investments in research, development and innovation are lagging behind other major economies; whereas promoting investments into pioneering demo and commercial production plants can accelerate the commercialization of European innovations: whereas lengthy authorisation procedures drive project developers out of the EU and hinder industrial deployment and growth; |
Or. en
Amendment 35
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Recital B
| Motion for a resolution | Amendment |
| 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; | B. whereas the EU is a global leader in research and biomanufacturing capacity, whereas a more coordinated policy framework is needed to efficiently scale up innovation, attract investments and commercialise new technologies which respect the precautionary principles, ensures high environmental and ethical standard and delivers public value; whereas unjustifiably lengthy authorisation procedures, mainly caused by the lack of administrative capacity, may drive project developers out of the EU and hinder industrial deployment and growth and may be improved for clarity and efficiency without undermining essential safeguards for health, biodiversity and democratic accountability; |
Or. en
Amendment 36
Anthony Smith
Motion for a resolution
Recital B
| Motion for a resolution | Amendment |
| 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; | 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; |
Or. en
Amendment 37
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia, Pascale Piera
Motion for a resolution
Recital B
| Motion for a resolution | Amendment |
| 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; | B. whereas the EU is a global leader in research and biomanufacturing capacity, yet needs a sufficiently coordinated 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 which is jeopardising this leadership position; |
Or. en
Amendment 38
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Oihane Agirregoitia Martínez, Olivier Chastel, Christophe Grudler, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Recital B
| Motion for a resolution | Amendment |
| 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; | 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, particularly approval times, drive project developers out of the EU and hinder industrial deployment and growth; |
Or. en
Amendment 39
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Recital B a (new)
| Motion for a resolution | Amendment |
| B a. whereas the outermost regions (ORs) of the European Union possess vast and still underexploited maritime areas endowed with exceptional biodiversity and strong innovation potential; whereas marine biotechnologies offer unique opportunities for economic development, environmental sustainability and strategic autonomy, notably in the pharmaceutical sector, aquaculture, cosmetic applications, and algae-based value chains; whereas the development of a sovereign and place-based innovation strategy in the ORs is essential to create skilled employment and strengthen territorial cohesion; |
Or. en
Amendment 40
Carlo Ciccioli
Motion for a resolution
Recital B a (new)
| Motion for a resolution | Amendment |
| B a. whereas lengthy and complex authorisation for the development, commercialisation and import of biotech products represent a competitive disadvantage for EU operators, drive project developers outside the EU, and hinder industrial deployment and growth; whereas the existing regulatory authorisation processes for biotech products needs to be urgently addressed to ensure that Europe remains globally competitive; |
Or. en
Amendment 41
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital B a (new)
| Motion for a resolution | Amendment |
| B a. 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 in essential medicines; |
Or. en
Amendment 42
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Recital C
| Motion for a resolution | Amendment |
| 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; | C. whereas Europe’s biotechnology and biomanufacturing investment and venture capital ecosystem remains fragmented and mostly confined at national scale; whereas high energy costs and a lack of access to appropriate investment and markets may represent challenges for start-ups and other small and medium-sized enterprises (SMEs) to scale up; whereas biomanufacturing capacity and supply chain circularity, sustainability and resilience are essential to reduce dependence on non-EU actors, to modernise and decarbonise Europe's industry, to protect the environment and enhance ecosystems’ functions and biodiversity; |
Or. en
Amendment 43
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital C
| Motion for a resolution | Amendment |
| 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; | 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 and for large scale deployment; whereas biomanufacturing capacity and supply chain resilience, including availability of feedstocks, are essential to reduce dependence on non-EU actors; |
Or. en
Amendment 44
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Recital C
| Motion for a resolution | Amendment |
| 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; | C. whereas Europe’s biotechnology and biomanufacturing investment and venture capital ecosystem remains fragmented; whereas high energy prices, regulatory burdens and barriers to accessing key feedstocks, raw materials and components 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; |
Or. en
Amendment 45
Carlo Ciccioli
Motion for a resolution
Recital C
| Motion for a resolution | Amendment |
| 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; | C. whereas Europe’s biotechnology and biomanufacturing investment and venture capital ecosystem remains fragmented; whereas private equity is essential for the sector’s companies, with this reliance being particularly acute for SMEs and start-ups, yet it currently remains insufficient to fully meet their needs; |
Or. en
Amendment 46
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Recital C
| Motion for a resolution | Amendment |
| 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; | C. whereas Europe’s biotechnology and biomanufacturing investment and venture capital ecosystem remains less competitive than some third-countries; 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; |
Or. en
Amendment 47
Anthony Smith
Motion for a resolution
Recital C a (new)
| Motion for a resolution | Amendment |
| C a. whereas public authorities provide key infrastructure and support that are necessary for the sustainable development of biotechnology and biomanufacturing; whereas public research institutes and universities play a critical role in advancing the fundamental research required for the sector; whereas public regulatory authorities as well as environmental agencies are essential bodies in ensuring compliance with environmental and social standards; whereas public institutions must be provided with the necessary resources, including human and financial, to fulfil their mission within timelines that facilitate sector development; |
Or. en
Amendment 48
Carlo Ciccioli
Motion for a resolution
Recital C a (new)
| Motion for a resolution | Amendment |
| C a. whereas costly regulatory burdens, high energy prices as well as barriers to accessing 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; whereas, at the same time, effective global supply chains — including strategic partnerships with reliable global actors—are equally vital to secure stable access to critical resources, avoid supply disruptions, and foster continuous innovation in essential technologies; |
Or. en
Amendment 49
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Olivier Chastel, Sigrid Friis, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Recital C a (new)
| Motion for a resolution | Amendment |
| C a. highlights the importance to increase the use of sustainable biobased raw materials as a part of the solution to reach a net-zero chemicals and plastics industry in 2050; Stresses the potential of biotechnology to transform the refinery and chemical industry towards biomanufacturing to reduce greenhouse gas emissions to reach the EU climate objectives; |
Or. en
Amendment 50
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital C a (new)
| Motion for a resolution | Amendment |
| C a. whereas the Commission is expected to present an updated Bioeconomy strategy by end of 2025; whereas current EU regulatory frameworks do not cater specifically to the specificities of bio-based products; |
Or. en
Amendment 51
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital C b (new)
| Motion for a resolution | Amendment |
| C b. whereas the demand for biomass may increase in the future, highlighting the importance of ensuring that adequate and coherent sustainability criteria is in place to ensure the sustainable production and processing of biomass not already covered by existing EU sustainability criteria; |
Or. en
Amendment 52
Carlo Ciccioli
Motion for a resolution
Recital C b (new)
| Motion for a resolution | Amendment |
| C b. whereas mobilising private and public investments in first of its kind demo and commercial production plants is of crucial importance to accelerate the commercialization of European innovations in the bio-based industries; |
Or. en
Amendment 53
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Recital D
| Motion for a resolution | Amendment |
| 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; | D. whereas current EU regulatory frameworks for biotechnology and biomanufacturing must be tailored to sector specific needs, while maintaining enough similarities to allow for legal certainty and consistent enforcement across the internal market, thus enabling access for innovative solutions; whereas regulatory sandboxes could be expanded to ensure that emerging technologies have adequate testing environments before fully investing into specific development pathways; 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; whereas any legislation must include strong environmental and sustainability safeguards to ensure biotech developments do not compromise ecological integrity or human health; |
Or. en
Amendment 54
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital D
| Motion for a resolution | Amendment |
| 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; | D. 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 application of Union law, such as the mutual recognition procedure remains inconsistent across Member States; 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 industries; |
Or. en
Amendment 55
Sigrid Friis
Motion for a resolution
Recital D
| Motion for a resolution | Amendment |
| 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; | 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 administrative optimisations to EU authorisation processes of new innovations should be considered, including in the Novel Foods Regulation (2015/2283); 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; |
Or. en
Amendment 56
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Recital D
| Motion for a resolution | Amendment |
| 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; | 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 the lengthy authorisation processes, particularly approval times, needs to be urgently addressed and improved to compete with timelines outside the EU; 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; |
Or. en
Amendment 57
Anthony Smith
Motion for a resolution
Recital D
| Motion for a resolution | Amendment |
| 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; | D. whereas current EU regulatory frameworks for biotechnology and biomanufacturing are inconsistent across sectors, creating legal uncertainty; 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; |
Or. en
Amendment 58
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia, Pascale Piera
Motion for a resolution
Recital D
| Motion for a resolution | Amendment |
| 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; | 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 designed 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; |
Or. en
Amendment 59
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Recital D a (new)
| Motion for a resolution | Amendment |
| D a. whereas the forthcoming legislative proposal on biotechnology must not be based solely on industrial policy and competitiveness considerations, but must also fully take into account the body of bioethical regulations and principles in force within the Union and its Member States; whereas such a framework must include, inter alia, strict compliance with the rules governing genetically modified organisms (GMOs), the prohibition of certain biotechnological practices deemed incompatible with human dignity, safeguards concerning the manipulation of human embryos and germ cells, regulations on the use of stem cells and synthetic gametes, prior authorisation procedures for clinical and medical applications, transparency obligations, requirements regarding the protection of genetic data, as well as overall respect for fundamental rights as enshrined in the Charter of Fundamental Rights of the European Union; whereas Member States must retain the right to adopt more restrictive measures in the field of bioethics, without such measures being considered as obstacles to the functioning of the internal market or to the development of the Union’s industrial strategy; |
Or. en
Amendment 60
Adam Jarubas
Motion for a resolution
Recital D a (new)
| Motion for a resolution | Amendment |
| D a. whereas, in the context of incresaing AMR, the EU Biotech Act should recognize alternative and innovative tretaments and support legal clarity as well as harmonized innovation and market access pathways e.g. in case of bacteriophages, which represent a key class of biological agents with high potential to address antimicrobial resistance (AMR), support microbiome-targeted precision therapies, enable green biocontrol in food and agriculture, and contribute to EU biosecurity and sustainability strategies. |
Or. en
Amendment 61
Carlo Ciccioli
Motion for a resolution
Recital D a (new)
| Motion for a resolution | Amendment |
| D a. whereas an effective regulatory framework for conducting clinical research is essential for the competitiveness of the most innovation-intensive aspects of the EU’s pharmaceuticals and biotechnology sector; whereas lack of harmonisation and streamlining of divergent standards applied by competent authorities across Member States slows down the assessment of applications for multi-country clinical studies and makes the process more costly and burdensome; |
Or. en
Amendment 62
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital D a (new)
| Motion for a resolution | Amendment |
| D a. whereas public awareness and public acceptance in the EU of biotechnology and biomanufactured products should be further strengthened; |
Or. en
Amendment 63
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital D b (new)
| Motion for a resolution | Amendment |
| D b. whereas the ethical aspects of biotechnology should be monitored carefully; whereas civil society plays a crucial role in shaping responsible and ethical biotechnology policies, and can act as a bridge between technical communities, relevant stakeholders, and the general public; whereas civil society’s role is essential in ensuring public trust, promoting ethical considerations, and safeguarding human and environmental health; whereas regular dialogue and inclusive stakeholder consultations are important in ensuring ethical aspects are included in biotechnology-related policies; |
Or. en
Amendment 64
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Recital D b (new)
| Motion for a resolution | Amendment |
| D b. whereas the ethical foundation of the European Union should be based on core values such as the inviolability of human dignity, the integrity of the person, the primacy of the human being over the sole interest of science or society, the prohibition of reproductive cloning and eugenic practices, the requirement of free and informed consent for any medical intervention, the prohibition of financial gain from the human body and its parts, the non-patentability of living matter, and the rejection of discrimination based on genetic characteristics; |
Or. en
Amendment 65
Anthony Smith
Motion for a resolution
Recital D b (new)
| Motion for a resolution | Amendment |
| D b. whereas new EU-wide regulation in the form of an EU biotech act should must include an ambitious social chapter to take into account the challenges that workers will face; whereas quality jobs, good working conditions and decent wages will be essential to support workers through the transition in this emerging sector; whereas trade unions and collective bargaining instruments shall play a critical role in ensuring the sustainable development of the sector in a fiercely competitive environment; |
Or. en
Amendment 66
Anthony Smith
Motion for a resolution
Recital D b (new)
| Motion for a resolution | Amendment |
| D b. whereas any public support to biotechnology and biomanufacturing companies should be made conditional to the respect of strict social and environmental conditionality as well as the prohibitions of layoffs and the distribution of excessive dividends to shareholders; |
Or. en
Amendment 67
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Recital D c (new)
| Motion for a resolution | Amendment |
| D c. whereas Member States have significant discretion in the application and interpretation of bioethical principles; whereas any future regulation in the field of biotechnology must fully respect these fundamental principles while allowing for scientific progress and industrial development; |
Or. en
Amendment 68
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital D c (new)
| Motion for a resolution | Amendment |
| D c. whereas 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; |
Or. en
Amendment 69
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital D d (new)
| Motion for a resolution | Amendment |
| D d. whereas, seamless data integration of disparate data sources including genomic, proteomic and clinical data and interoperability is needed to enable Artificial Intelligence (AI) systems to deliver meaningful insights; |
Or. en
Amendment 70
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital D e (new)
| Motion for a resolution | Amendment |
| D e. whereas the intersection AI and health biotechnology can drive innovation into personalised medicine and drug discovery, bringing health and environmental benefits; whereas the integration of AI in biotechnology also presents ethical challenges, which must be addressed to ensure responsible innovation and societal benefit; whereas key concerns include data privacy and security, as AI systems often handle sensitive genetic and health data, necessitating a robust ethical framework to protect individuals’ rights and maintain public trust; whereas any use of personal and non-personal data needs to be done under stringent measures of pseudonomisation and anonymization respectively; |
Or. en
Amendment 71
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital D f (new)
| Motion for a resolution | Amendment |
| D f. whereas the current EU regulatory framework does not adequately address the evolving risks, opportunities, and responsibilities associated with the handling, trade, and synthesis of biological material, particularly in the context of synthetic biology and AI-enabled biotechnology; whereas mandatory universal regulations requiring nucleic acid synthesis companies to screen their orders do not currently exists; whereas this security gap must be addressed by the EU and through international cooperation; whereas the lack of enforceable standards puts society at risk and security-conscious companies at a competitive disadvantage; |
Or. en
Amendment 72
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Recital D g (new)
| Motion for a resolution | Amendment |
| D g. whereas to ensure a level playing field and responsible innovation, EU research funding should be tied to compliance with clearly defined and externally verified biosecurity standards; |
Or. en
Amendment 73
Carlo Ciccioli
Motion for a resolution
Subheading 1 a (new)
| Motion for a resolution | Amendment |
| Underlines the importance to ensure coherence and complementarity across all legislations which can impact the growth of European biotechnology and bionamufacturing companies, avoiding duplications of efforts already made under existing frameworks; calls on the Commission to provide the future Biotech Act with an explanation of its interaction with other relevant legislative and non-legislative initiatives; |
Or. en
Amendment 74
Morten Løkkegaard, Yvan Verougstraete, Olivier Chastel, Christophe Grudler
Motion for a resolution
Subheading 1 a (new)
| Motion for a resolution | Amendment |
| Calls on the Commission to define biotech and biomanufacturing, in line with the OECD definition of biotechnology: biotechnology applies science and technology to living organisms, as well as parts, products and models of them, to alter living or non-living materials to produce knowledge, goods and services; |
Or. en
Amendment 75
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 1
| Motion for a resolution | Amendment |
| 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; | 1. Welcomes the new EU-wide regulation in form of an EU Biotech Act to address concrete gaps and short-comings in existing legislation and implementation, focusing on the specificities of the industry; |
| Underlines Parliament’s commitment to the ‘one in, one out’ and simplification principles; asks that the EU Biotech Act is accompanied by competitiveness checks, including proposals currently undergoing the co-legislative procedure, as well as impact and cost assessment, and comprehensive assessment by the Regulatory Scrutiny Board; calls that the checks and assessments take into consideration the impact on SME’s, start-ups and scale-ups. |
Or. en
Amendment 76
Anthony Smith
Motion for a resolution
Paragraph 1
| Motion for a resolution | Amendment |
| 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; | 1. 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; asks that an ambitious social chapter be included in the EU biotech act to take into account the many challenges workers will face in this sector, such as the necessary upskilling in cutting-edge sectors, potential hazardous workplaces in which occupational health and safety highest standards must be guaranteed as well as good working conditions and decent wages to ensure the attractiveness of the sector; |
Or. en
Amendment 77
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 1
| Motion for a resolution | Amendment |
| 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; | 1. Calls on the Commission to consider proposing a EU Biotech Act with a broad scope that covers a comprehensive range of sectors using biotechnology applications and biomanufacturing technologies, to capture the full potential; calls on the Commission for coherent EU legislation in the field of biotechnology and biomanufacturing; emphasizes that new legislative proposals must be aligned with better regulation principles, ensuring that any new measures are accompanied by an impact assessment; |
Or. en
Amendment 78
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 1
| Motion for a resolution | Amendment |
| 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; | 1. Underlines that the biotechnology and biomanufacturing are new industrial areas and the regulatory regime must be flexible enough to allow for development while providing enough safety and security safeguards; asks that the EU biotech act be based on simple and clear rules and accompanied by an impact and cost assessment, as well as a comprehensive assessment by the Regulatory Scrutiny Board and an opinion of the European Scientific Advisory Board on Climate Change; |
Or. en
Amendment 79
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 1
| Motion for a resolution | Amendment |
| 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; | 1. Underlines Parliament’s commitment to the ‘one in, one out’ and simplification principles; asks therefore, if a EU Biotech Act is proposed as announced by the Commission, to present legislation which can be abolished, simplified, streamlined or where bureaucratic burden can be reduced; 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; |
Or. en
Amendment 80
Dimitris Tsiodras
Motion for a resolution
Paragraph 1
| Motion for a resolution | Amendment |
| 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; | 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, covering the entire biotech ecosystem and life-cycle, as well as a comprehensive assessment by the Regulatory Scrutiny Board; |
Or. en
Amendment 81
Katri Kulmuni
Motion for a resolution
Paragraph 1 a (new)
| Motion for a resolution | Amendment |
| 1 a. Calls on the Commission to define biotech and biomanufacturing, biotech in line with the OECD definition of biotechnology: biotechnology applies science and technology to living organisms, as well as parts, products and models of them, to alter living or non-living materials to produce knowledge, goods and services and biomanufacturing in a technology-neutral manner, so as to broadly encompass the production of bio-based materials and products, including, but not limited to, through chemical, mechanical, or thermal processes. |
Or. en
Amendment 82
Carlo Ciccioli
Motion for a resolution
Paragraph 1 a (new)
| Motion for a resolution | Amendment |
| 1 a. Underlines that mapping key industrial bio-based value chains is essential for identifying bottlenecks and systemic inefficiencies hindering biotechnology and biomanufacturing; recalls that such an assessment should serve as a robust foundation for the Biotech Act, enabling it to effectively address these constraints and streamline regulatory processes; |
Or. en
Amendment 83
Carlo Ciccioli
Motion for a resolution
Paragraph 2
| Motion for a resolution | Amendment |
| 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; | 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 and Biomanufacturing Officer’, in the Commission to ensure alignment and coordination across all policy domains that impact the sector; recommends securing framework conditions ensuring a fast and efficient uptake of biotechnology and biomanufacturing, particularly in those areas that lead to direct and positive effects for citizens and patients across the EU; |
Or. en
Amendment 84
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 2
| Motion for a resolution | Amendment |
| 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; | 2. Recommends streamlining and harmonising upcoming and current initiatives relating to biotechnology and biomanufacturing, such as the forthcoming review of the EU’s bioeconomy strategy and the life sciences strategy, the Circular Economy Act, the Innovation Act, and the recently adopted Clean Industrial Deal and the Communication on the Vision For Agriculture And Food, 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 and Biomanufacturing Officer’, in the Commission to foster greater coherence across legislation and enable more efficient scale-up and commercialisation of RDI results; |
Or. en
Amendment 85
Diana Iovanovici Şoşoacă
Motion for a resolution
Paragraph 2
| Motion for a resolution | Amendment |
| 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; | 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; recommends implementing a stable, predictable and balanced intellectual property framework to safeguard and harness biotechnology innovation and facilitate access to finance to ensure a dynamic biotech ecosystem in the EU; calls for the creation of a single coordination body, such as a ‘Chief Biotechnology Officer’, in the Commission; |
Or. ro
Amendment 86
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin
Motion for a resolution
Paragraph 2
| Motion for a resolution | Amendment |
| 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; | 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; in order to ensure coordination, coherence, and complementarity across relevant Directorate-Generals such as DG GROW, DG RTD and DG SANTE; highlights the importance of efforts to improve policy coherence and coordination on national level; |
Or. en
Amendment 87
Sigrid Friis
Motion for a resolution
Paragraph 2
| Motion for a resolution | Amendment |
| 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; | 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, the Commission’s Communication on the Vision For Agriculture And Food, the review of the Common Agricultural Policy (CAP), the Startup and Scaleup Strategy, and the Innovation Act, 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; |
Or. en
Amendment 88
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 2
| Motion for a resolution | Amendment |
| 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; | 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; urges the Commission to ensure coherence and consistency across all initiatives and legislative measures that may affect biotechnology innovations, start-ups and companies; calls for the creation of a single coordination body, such as a “Chief Biotechnology Officer, in the Commission; |
Or. en
Amendment 89
Anthony Smith
Motion for a resolution
Paragraph 2
| Motion for a resolution | Amendment |
| 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; | 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; who should, as part of its portfolio, cover ethical, social and democratic issues related to the deployment of biotechnologies; |
Or. en
Amendment 90
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 2
| Motion for a resolution | Amendment |
| 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; | 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 and with clear environmental and circularity benchmarks embedded across all strategies; calls for the creation of a single coordination body, such as a ‘Chief Biotechnology Officer’, in the Commission; |
Or. en
Amendment 91
Marcin Sypniewski
Motion for a resolution
Paragraph 2
| Motion for a resolution | Amendment |
| 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; | 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; |
Or. en
Amendment 92
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 2
| Motion for a resolution | Amendment |
| 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; | 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; |
Or. en
Amendment 93
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera
Motion for a resolution
Paragraph 2 – subparagraph 1 (new)
| Motion for a resolution | Amendment |
| calls on the Commission to integrate the blue bioeconomy dimension into the forthcoming legislative proposal on biotechnology, and to develop a dedicated roadmap for marine biotechnologies in the outermost regions (ORs); supports the establishment of regional centres of excellence in marine biotechnology within the ORs, in close coordination with local universities, research institutes and small and medium-sized enterprises (SMEs); urges, accordingly, the simplification and long-term stabilisation of EU funding instruments for research and innovation in marine biotechnology, notably under Horizon Europe, InvestEU and the European Regional Development Fund; underlines, in this regard, the need to adapt European regulatory frameworks to the specific socio-economic and ecological realities of the outermost regions, in full respect of the principle of subsidiarity and the maritime sovereignty of the Member States; |
Or. en
Amendment 94
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 2 a (new)
| Motion for a resolution | Amendment |
| 2 a. Calls on the Commission to ensure that upcoming legislative initiatives have a broad enough scope to capture the width of the sectors included, and underlines especially that the upcoming Biotech Act should comprehend the full range of biotechnology and biomanufacturing applications; |
Or. en
Amendment 95
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 2 a (new)
| Motion for a resolution | Amendment |
| 2 a. Welcomes the recently launched Biotech and Biomanufacturing hub to guide and advise companies to navigate through the regulatory framework; |
Or. en
Amendment 96
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 3
| Motion for a resolution | Amendment |
| 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; | 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 industries applying these technologies and manufacturing processes; urges the Commission to share with Parliament the preliminary findings of its study on regulatory frameworks in the EU and Member States and the potential need to improve implementation or update legislation related to biotechnology and biomanufacturing; considers that some requirements could be simplified across regulatory frameworks to enable faster approval procedures and market access, while maintaining a risk-based and science-based approach; underlines that the simplification of EU legislation must not endanger any of the fundamental rights or create regulatory uncertainty; considers that oversimplification could negatively affect environmental and social standards; |
Or. en
Amendment 97
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Paragraph 3
| Motion for a resolution | Amendment |
| 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; | 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; stresses nevertheless that such regulatory simplification must under no circumstances come at the expense of the Member States’ bioethical rules; |
Or. en
Amendment 98
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 3
| Motion for a resolution | Amendment |
| 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; | 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, including the barriers to improving the EU’s self-sufficiency in key feedstocks, raw materials and components; 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; |
Or. en
Amendment 99
Diana Iovanovici Şoşoacă
Motion for a resolution
Paragraph 3
| Motion for a resolution | Amendment |
| 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; | 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 in the medium- and long-term; 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 as soon as possible; calls for a biotechnology omnibus that simplifies current requirements for the sector across regulatory frameworks; |
Or. ro
Amendment 100
Marcin Sypniewski
Motion for a resolution
Paragraph 3
| Motion for a resolution | Amendment |
| 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; | 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 in biotechnology and biomanufacturing; recalls that there is no dedicated EU legislation governing biotechnology and biomanufacturing and stresses the importance of respecting Member States' competences in this area, including their ethical and legal frameworks; |
Or. en
Amendment 101
Anthony Smith
Motion for a resolution
Paragraph 3
| Motion for a resolution | Amendment |
| 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; | 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 as well as the strengthening of the precautionary principle in this context ; 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 while respecting and enforcing social and environmental standards; |
Or. en
Amendment 102
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 3
| Motion for a resolution | Amendment |
| 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; | 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 that are unjustifiably hampering the growth of the industry, with full compliance with the Treaty obligations for a high level of safety for citizens and environment; 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; |
Or. en
Amendment 103
Hildegard Bentele, Christian Ehler, Matej Tonin, Niels Flemming Hansen, Andrea Wechsler
Motion for a resolution
Paragraph 3 a (new)
| Motion for a resolution | Amendment |
| 3 a. Asks the Commission to provide guidance to European biotechnology and biomanufacturing companies and the Member States with regard to the new possibilities and unintended limitations under the Net-Zero- Industry Act (NZIA) as well as the new Clean Industrial Deal in terms of permitting, financing and creating respective hubs, for example via an up-date of the recently established EU Biotech and biomanufacturing Hub; |
Or. en
Amendment 104
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 3 a (new)
| Motion for a resolution | Amendment |
| 3 a. Calls on the Commission to carry out a study of Horizon Europe, as well as previous, but still ongoing, R&I programmes such as Horizon 2020 and the 7th Framework Programme, in order to gather best practices in project funding and to analyse cases where investments have not delivered results, with a view to preparing future initiatives on biotechnology and biomanufacturing ; |
Or. en
Amendment 105
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 3 b (new)
| Motion for a resolution | Amendment |
| 3 b. Stresses that an approach disproportionately focused on environmental impact, without taking into account economic and social factors, has already caused harm in other industrial sectors; calls on the Commission to carry out a well-designed impact assessment to ensure that the new biotechnology strategy is a driver of growth and innovation, rather than creating unnecessary obstacles; |
Or. en
Amendment 106
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 4
| Motion for a resolution | Amendment |
| 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; | 4. Calls on the Commission to streamline, harmonise and simplify authorisation procedures for biotechnology materials and manufacturing, while maintaining a risk proportionate and peer-reviewed science-based approach to keep authorisation timeline below the target year set; calls for introducing pre-notification process in agencies, enhancing advisory and support services and re-enforcing staff where timelines are not met; stresses that the insufficient staff or capacities of public administrations to process authorisations remains a key issue, and urges the Member States to reinforce such capacities; stresses the importance of robust EU-wide harmonisation of market authorisation procedures to enable companies to launch their bio-based products seamlessly across all Member States and offer companies access to a true Single market; underlines that the Draghi report concludes that innovation hubs across the EU do not reach critical mass compared to rival US hubs due to EU’s fragmented approach and Member’s State national interest to support local champions in a dispersed landscape; |
Or. en
Amendment 107
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 4
| Motion for a resolution | Amendment |
| 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; | 4. Calls on the Commission to streamline and simplify authorisation procedures for biotechnology products, materials and manufacturing, while maintaining a risk proportionate and science-based approach, focusing on requirements which genuinely reduce the risk for health and environment, and where applicable, taking into account the contribution to the EU climate and circularity objectives, in particular in the context of the upcoming review of EU agencies such as the European Food Safety Authority and the European Chemicals Agency; calls on the Commission to ensure adequate staffing of the relevant EU agencies, to enhance their capacity, also in regards to conducting authorisation procedures in a timely manner; |
Or. en
Amendment 108
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Paragraph 4
| Motion for a resolution | Amendment |
| 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; | 4. Calls on the Commission to reassess 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; stresses that such simplification must not be carried out unilaterally, but rather in close coordination with national biomedical agencies or any other institutional body competent under the legal frameworks specific to each Member State, in full respect of the principles of subsidiarity and proportionality; |
Or. en
Amendment 109
Anthony Smith
Motion for a resolution
Paragraph 4
| Motion for a resolution | Amendment |
| 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; | 4. Calls on the Commission to make authorisation procedures more efficient, while respecting social and environmental standards, 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; calls on the Commission to provide EU agencies in the field of biotechnology with adequate resources, including human and financial resources, to fulfil their tasks and control the respect of social and environmental standards; |
Or. en
Amendment 110
Carlo Ciccioli
Motion for a resolution
Paragraph 4
| Motion for a resolution | Amendment |
| 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; | 4. Calls on the Commission to streamline and simplify authorisation procedures for biotechnology products, 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 and in addition to consider the cumulative impact on the EU biomanufacturing sector and medicines supply of interlinked chemical, environmental and food legislation; |
Or. en
Amendment 111
Katri Kulmuni
Motion for a resolution
Paragraph 4
| Motion for a resolution | Amendment |
| 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; | 4. Calls on the Commission to streamline and simplify authorisation procedures for companies for biotechnology materials and manufacturing, while maintaining a risk proportionate and science-based approach where the actions are limited to those that genuinely reduce the risk for health and environment, in particular in the context of the upcoming review of REACH and European agencies such as the European Food Safety Authority and the European Chemicals Agency; |
Or. en
Amendment 112
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 4
| Motion for a resolution | Amendment |
| 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; | 4. Calls on the Commission to urgently streamline, simplify and shorten the time for authorisation procedures, particularly approval times for biotechnology materials and manufacturing, as well as the market uptake of bio-based solutions, while maintaining a risk proportionate and science-based approach, in particular in the context of the upcoming review of European agencies such as the European Food Safety Authority and the European Chemicals Agency; |
Or. en
Amendment 113
Eszter Lakos, Letizia Moratti
Motion for a resolution
Paragraph 4
| Motion for a resolution | Amendment |
| 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; | 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, the European Medicines Agency, and the European Chemicals Agency; |
Or. en
Amendment 114
Dimitris Tsiodras
Motion for a resolution
Paragraph 4
| Motion for a resolution | Amendment |
| 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; | 4. Calls on the Commission to streamline and simplify authorisation procedures for biotechnology materials and manufacturing, throughout their life-cycle, 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; |
Or. en
Amendment 115
Adam Jarubas
Motion for a resolution
Paragraph 4
| Motion for a resolution | Amendment |
| 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; | 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, European Medicines Agency and the European Chemicals Agency; |
Or. en
Amendment 116
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 4
| Motion for a resolution | Amendment |
| 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; | 4. Calls on the Commission to streamline and simplify authorisation procedures for biotechnology materials, products 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; |
Or. en
Amendment 117
Diana Iovanovici Şoşoacă
Motion for a resolution
Paragraph 4 a (new)
| Motion for a resolution | Amendment |
| 4a. Highlights the need to implement a labelling system for non-food biotechnological products in order to correctly inform consumers on the bio-based content of a product, to increase public awareness and facilitate the choice of those products; stresses that a rapid increase in demand for bio-based products will boost the commercialisation of innovative solutions in the field of biotechnology and biotechnological production, while also potentially reducing production costs and accelerating the entry of new products onto the market; |
Or. ro
Amendment 118
Carlo Ciccioli
Motion for a resolution
Paragraph 4 a (new)
| Motion for a resolution | Amendment |
| 4 a. Calls on the Commission to ensure simplification of the European Medicines Agency’s (EMA) committee structure for faster regulatory assessments together with shorter centralized procedure timelines; highlights, in this context, to follow best practices from other leading regulatory agencies to ensure faster and more seamless approval procedures without compromising patient safety; |
Or. en
Amendment 119
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 4 a (new)
| Motion for a resolution | Amendment |
| 4 a. Calls on the Commission to assess the introduction of a risk-based approach in the drafting of the new EU Biotech Act in order to allow the necessary flexibility according to the sector and type of biotechnology industry, while maintaining the highest standards of quality and safety and coherent with the bioethics and human dignity; |
Or. en
Amendment 120
Diana Iovanovici Şoşoacă
Motion for a resolution
Paragraph 4 b (new)
| Motion for a resolution | Amendment |
| 4b. Draws attention to the fact that in order to succeed on the market, bio-based products must prove their sustainability and lower environmental impact compared, for example, to petrochemical products; at the same time stresses the need to assess the life cycle of bio-based products on the basis of common criteria at European level in order to analyse the environmental impact of such products; |
Or. ro
Amendment 121
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 5
| Motion for a resolution | Amendment |
| 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; | 5. Recalls that harmonised and internationally competitive intellectual property protection rules for biotechnology and biomanufacturing patents are essential for the development of the industry, with due regard to the need for public interest exceptions and the need to avoid lock-in effects; recognises the need to ensure transparency, public return on investment, and safeguards against monopolisation in biotechnology and bio manufacturing patents; calls the Commission to explore options to facilitate cross-border clinical trials; calls for the establishment of a common clinical trials framework that enables the use of real-world evidence, when complementary to clinical trial data and subject to strict scientific reliability standard, for biotechnology therapies; asks the Commission to present the current situation in this regard, including challenges related to access, transparency, and the responsible use of data, and to propose improvements accordingly; |
Or. en
Amendment 122
Anthony Smith
Motion for a resolution
Paragraph 5
| Motion for a resolution | Amendment |
| 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; | 5. Recalls that harmonised and internationally competitive intellectual property protection rules for biotechnology and biomanufacturing patents are essential for the development of the industry; stresses that patenting and respect for intellectual property must be limited to what is strictly necessary for the sustainable development of the sector in order, in particular, to guarantee public control over technologies of public interest; 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; |
Or. en
Amendment 123
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 5
| Motion for a resolution | Amendment |
| 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; | 5. Recalls that harmonised and internationally competitive intellectual property (IP) protection rules for biotechnology and biomanufacturing patents are essential for the development of the industry; considers that a robust, future-proof IP framework is essential to ensure that scientific breakthroughs translate into tangible societal and environmental benefits, resilient supply chains, and sustainable economic growth; 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; |
Or. en
Amendment 124
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Paragraph 5
| Motion for a resolution | Amendment |
| 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; | 5. Recalls that harmonised and internationally competitive intellectual property protection rules for biotechnology and biomanufacturing patents are essential for the development of the industry; |
Or. en
Amendment 125
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Christian Ehler, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 5
| Motion for a resolution | Amendment |
| 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; | 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; underlines the importance of improving intellectual property protection rules to strengthen the EU's competitiveness and autonomy; |
Or. en
Amendment 126
Letizia Moratti
Motion for a resolution
Paragraph 5
| Motion for a resolution | Amendment |
| 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; | 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 to design streamlined approval procedures across Member States to minimize administrative burden and delays and 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; |
Or. en
Amendment 127
Carlo Ciccioli
Motion for a resolution
Paragraph 5
| Motion for a resolution | Amendment |
| 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; | 5. Recalls that harmonised, predictable and internationally competitive intellectual property protection rules for biotechnology, biomanufacturing and life sciences patents are essential for the development of innovative products in industrial, pharmaceutical, and agricultural sectors in the EU and underlines that data sharing requirements must not compromise the protection of such innovation; underlines the importance for EU competitiveness and autonomy to improving patenting rates for biotech and biomanufacturing; |
Or. en
Amendment 128
Adam Jarubas
Motion for a resolution
Paragraph 5
| Motion for a resolution | Amendment |
| 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; | 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 i.a. novel antimicrobials like bacteriophages; asks the Commission to present the current situation in this regard, as well as potential improvements; |
Or. en
Amendment 129
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 5 a (new)
| Motion for a resolution | Amendment |
| 5 a. Underlines that a coherent and predictable IP system can foster innovation and Europe’s strategic autonomy, protect cutting-edge technologies, reward long-term investment, and support high-risk research; notes that supplementary Protection Certificates (SPCs) play a crucial role in this landscape by compensating for lengthy regulatory approval processes in life sciences; considers that the ongoing SPC reform must deliver a centralized, efficient, and transparent procedure, especially in aligning with the unitary patent system, to reduce fragmentation and ensure legal certainty for innovators across Member States; notes that open-source biotechnology initiatives are creating new opportunities for accessible, community-driven innovation; |
Or. en
Amendment 130
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 5 a (new)
| Motion for a resolution | Amendment |
| 5 a. Takes note of the high level of personal data protection in the Union through legislation such as the General Data Protection Regulation (GDPR); nevertheless, calls on the European Commission to carry out an analysis to identify any gaps or loopholes that could pose a risk to Europeans' medical and genomic data, in order to prevent such data from ending up in third countries; at the same time, calls on the Commission to assess whether the current legislation may act as a barrier to innovation in the internal market, with a view to finding appropriate solutions; |
Or. en
Amendment 131
Carlo Ciccioli
Motion for a resolution
Paragraph 5 a (new)
| Motion for a resolution | Amendment |
| 5 a. Underlines the strategic importance for the EU of a strong health biotech ecosystem to support the 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-patents and innovative medicines; calls for a common clinical trials framework that allows for the use of real-world evidence for biotech therapies and asks the Commission to present the current state in this regard as well as potential improvements; |
Or. en
Amendment 132
Carlo Ciccioli
Motion for a resolution
Paragraph 5 b (new)
| Motion for a resolution | Amendment |
| 5 b. Recalls the need for periodic assessments of trends in investment in R&D and manufacturing compared to other major markets and ensure key drivers of investments are sufficiently attractive to keep EU globally competitive; |
Or. en
Amendment 133
Anthony Smith
Motion for a resolution
Paragraph 6
| Motion for a resolution | Amendment |
| 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; | deleted |
Or. en
Amendment 134
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin
Motion for a resolution
Paragraph 6
| Motion for a resolution | Amendment |
| 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; | 6. Recommends using the next generation of regulatory sandboxes to assess the specific impact and possibilities of emerging biotechnology and biomanufacturing applications, such as those using genetically modified microorganisms, ensuring that new technologies can be trialled in a controlled but flexible regulatory environment; stresses the importance of ensuring EU policy takes account of technological and scientific developments to safeguard the EU’s global competitiveness; |
Or. en
Amendment 135
Carlo Ciccioli
Motion for a resolution
Paragraph 6
| Motion for a resolution | Amendment |
| 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; | 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; underlines the importance of ensuring EU regulatory frameworks are aligned with scientific and technological progress; |
Or. en
Amendment 136
Letizia Moratti
Motion for a resolution
Paragraph 6
| Motion for a resolution | Amendment |
| 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; | 6. Underline the importance of attracting R&D of novel technologies in the EU; 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 and future-proof regulatory environment; |
Or. en
Amendment 137
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 6
| Motion for a resolution | Amendment |
| 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; | 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 environment and benefiting from a flexible regulatory environment that facilitate ethical and safe innovation and development; |
Or. en
Amendment 138
Adam Jarubas
Motion for a resolution
Paragraph 6
| Motion for a resolution | Amendment |
| 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; | 6. Recommends using the next generation of regulatory sandboxes to assess the specific impact and possibilities of emerging biotechnology and biomanufacturing applications, i.a. clinical and industrial-scale bacteriophage applications, ensuring that new technologies can be trialled in a controlled but flexible regulatory environment; |
Or. en
Amendment 139
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 6
| Motion for a resolution | Amendment |
| 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; | 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, respecting the bioethics principle and human dignity; |
Or. en
Amendment 140
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 6 a (new)
| Motion for a resolution | Amendment |
| 6 a. Calls on the Commission to take immediate and decisive action to accelerate the approval processes for biotech products and biomanufacturing. |
Or. en
Amendment 141
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 6 a (new)
| Motion for a resolution | Amendment |
| 6 a. Suggestions for a new Bioeconomy Strategy |
Or. en
Amendment 142
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 6 b (new)
| Motion for a resolution | Amendment |
| 6 b. Calls on the Commission to present an updated bioeconomy strategy, which takes into account current challenges, and reinforces the bioeconomy's industrial dimension and its links to biotechnology and biomanufacturing, incentivising the development and production of sustainable, innovative, high-value added biobased materials, products and solutions, to contribute EU competitiveness and strategic autonomy; |
Or. en
Amendment 143
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 6 b (new)
| Motion for a resolution | Amendment |
| 6 b. Calls for the establishment of a dedicated fast track regarding approvals for biotech products that have already been approved by trusted regulatory bodies in like-minded countries, including but not limited to Norway, UK, Canada, Japan, Australia, and Switzerland. |
Or. en
Amendment 144
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 6 c (new)
| Motion for a resolution | Amendment |
| 6 c. Recommends developing a strategy to support biotechnology companies transitioning from the regulatory sandbox regime to full market access; requests that the strategy include, but not be limited to, financial support mechanisms, regulatory assistance, and guidance on compliance with EU legislation. |
Or. en
Amendment 145
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 6 d (new)
| Motion for a resolution | Amendment |
| 6 d. Calls on the Commission to simplify the labeling requirements and ensure fair market conditions between biotech and other products, including but not limited to marketing and advertising, without compromising consumer safety; |
Or. en
Amendment 146
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 7
| Motion for a resolution | Amendment |
| 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; | 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, calls on the Commission to review EU legislation that may affect the sector in order to identify potential barriers to the industry and to carry out the necessary amendments or repeals, including those stemming from the European Green Deal ; |
Or. en
Amendment 147
Diana Iovanovici Şoşoacă
Motion for a resolution
Paragraph 7
| Motion for a resolution | Amendment |
| 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; | 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; stresses the need to apply adequate safeguard measures in the production process for bio-based products so as to avoid accidents of any kind with adverse effects on the population and the environment in the medium and long term; |
Or. ro
Amendment 148
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 7
| Motion for a resolution | Amendment |
| 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; | 7. Underlines the need to account for the specificities of bio-based products and processes and welcomes the proposal of a Biotech Act to account for them, while ensuring that the specific regulation does not lead to unintended environmental externalities, such as impact on carbon and water cycling, deforestation, biodiversity loss or soil degradation due to intensive biomass production; |
Or. en
Amendment 149
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 7
| Motion for a resolution | Amendment |
| 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; | 7. Calls for EU regulatory frameworks to be adapted to differentiate between fossil-based products and the specificities of sustainable bio-based products; underlines the need to account for the specificities of biogenic carbon, bio-based products and processes in the context of chemical, materials and environmental legislation for petrochemical products; |
Or. en
Amendment 150
Carlo Ciccioli
Motion for a resolution
Paragraph 7 a (new)
| Motion for a resolution | Amendment |
| 7 a. Underlines that effectively scaling up biotechnology and biomanufacturing in Europe hinges on a robust and competitive bioeconomy; highlights that, in the upcoming revision of the Bioeconomy Strategy, it will be important to identify key sectors and products, setting out clear pathways to support their scale-up and strengthen the businesses operating in these areas; |
Or. en
Amendment 151
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 7 a (new)
| Motion for a resolution | Amendment |
| 7 a. Points out that essential components like enzymes or lactic acid bacteria and other microorganisms cannot run the risk of being prohibited or unduly disincentivised by European regulation primarily designed for petrochemical and synthetic substances, such as the REACH Regulation; |
Or. en
Amendment 152
Carlo Ciccioli
Motion for a resolution
Paragraph 7 b (new)
| Motion for a resolution | Amendment |
| 7 b. Acknowledges the important role primary biomass plays in biomanufacturing; recalls, in this regard, the importance of adopting a technology-neutral approach to biomass availability, grounded in robust analysis, with the aim of enhancing feedstock access and use as well as harnessing international supply chains; |
Or. en
Amendment 153
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 8
| Motion for a resolution | Amendment |
| 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; | 8. Welcomes the European Investment Bank’s interpretation of the sustainability criteria under the Paris alignment framework as a key way to ensure access to funding for the most sustainable bio-based materials and projects with lower environmental impact when compared, for instance, to petrochemical products hence ensuring they succeed on the market and do not result in stranded asset or inefficient spending; asks the Commission to monitor definitions accordingly and make clear sustainable and circular biotechnology and biomanufacturing-friendly interpretations; underlines that the Letta report calls for the specificities of deep-tech to be recognised; calls therefore for the EIB to propose de-risking instruments for deep-tech, and biotech specifically, to raise patient capital; |
Or. en
Amendment 154
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 8
| Motion for a resolution | Amendment |
| 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; | 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; moreover, calls on the EIB to improve outreach, advisory support and information on financing instruments and opportunities to eligible biotech and biomanufacturing projects, in particular SMEs and startups; |
Or. en
Amendment 155
Dimitris Tsiodras
Motion for a resolution
Paragraph 8
| Motion for a resolution | Amendment |
| 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; | 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; equally, the restrictive interpretation of ''innovation'' may deny access to state aid funding for off-patent-led innovation; asks the Commission to examine definitions accordingly and enforce biotechnology-and biomanufacturing-friendly interpretations; |
Or. en
Amendment 156
Anthony Smith
Motion for a resolution
Paragraph 8
| Motion for a resolution | Amendment |
| 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; | 8. Stresses that access to public financing, including facilities from the European Investment Bank, should be granted exclusively to projects and companies that align with the objectives of the Paris Agreement; asks the Commission to examine definitions accordingly and enforce biotechnology- and biomanufacturing-friendly interpretations in line with the Paris agreement; |
Or. en
Amendment 157
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 9
| Motion for a resolution | Amendment |
| 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; | 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; considers that to accelerate the substitution of fossil-based feedstocks the market demand and market uptake of sustainable bio-based products could further be incentivised in Europe; considers that biobased feedstocks, such as sustainable biomass, recycled waste and co2 captured from biogenic sources could be used as alternative feedstocks for the manufacturing of polymers, plastics, solvents, paints, detergents, cosmetics and pharmaceuticals, contributing to emission reduction, resource efficiency and strategic autonomy; in this context, recalls the commitment in the Competitiveness Compass to develop policies to reward early movers; furthermore, looks forward to the Commission impact assessment of the feasibility of bio-based content requirements in specific product categories and in public procurement; considers that coherent and adequate sustainability criteria should be ensured for biomass; |
Or. en
Amendment 158
Katri Kulmuni, Christophe Grudler
Motion for a resolution
Paragraph 9
| Motion for a resolution | Amendment |
| 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; | 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, where bio-based products should be prioritized; Underlies also the Product Environmental footprint (PEF) -methodology to be applied correctly (applying the -1/+1 accounting method consistently), to provide a clear understanding of the actual difference in CO2footprints between biomass-derived and fossil-based products over every life cycle, incentivizing reuse, recycling and extending the product lifetime; |
Or. en
Amendment 159
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 9
| Motion for a resolution | Amendment |
| 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; | 9. Underlines that bio-based products and processes could support the achievement of the EU’s climate objectives, when savings over their entire life cycle, including raw material sourcing, production, distribution, and end-of-life treatment are reflected in respective life cycle assessments, information for consumers and public procurement calls on the Commission to discourage greenwashing practices through improved environmental labelling and consumer information; |
Or. en
Amendment 160
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Paragraph 9
| Motion for a resolution | Amendment |
| 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; | 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; calls to exploit tbe full potential of industrial, energy, environmental and urban biotechnologies, as well as carbon capture and valorisation technologies, in order to promote a decarbonisation pathway based on innovation and efficiency; |
Or. en
Amendment 161
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 9
| Motion for a resolution | Amendment |
| 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; | 9. Underlines the benefit and contribution of bio-based products and processes to the EU’s CO2 reduction objectives, which with their potential to increase sustainability and lower the environmental footprint need to be reflected in respective life cycle assessments, information for consumers and public procurement which has been experienced already at regional level; |
Or. en
Amendment 162
Anthony Smith
Motion for a resolution
Paragraph 9
| Motion for a resolution | Amendment |
| 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; | 9. Underlines the potential 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; |
Or. en
Amendment 163
Diana Iovanovici Şoşoacă
Motion for a resolution
Paragraph 9 a (new)
| Motion for a resolution | Amendment |
| 9a. Stresses that the European bioeconomy must focus on sustainability and circularity, as these factors will result in a renewal of European industries in the medium and long term, modernisation of European primary production systems, protection of the environment and the improvement of biodiversity; |
Or. ro
Amendment 164
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 10
| Motion for a resolution | Amendment |
| 10. Points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite; | 10. Points out that society and economy can benefit from accelerated research and commercialisation of biotechnology, therefore calls on the Commission to identify fast and secure pathways to the market for products that can contribute to achieving EU policy goals; calls the Commission to consider best practices from Member States having introduced regulatory sandboxes looking into pre-market authorisation procedures, and to always ensure traceability and labelling; |
Or. en
Amendment 165
Paolo Borchia, Raffaele Stancanelli, Silvia Sardone, Isabella Tovaglieri, Auke Zijlstra, Pascale Piera, Margarita de la Pisa Carrión, Barbara Bonte
Motion for a resolution
Paragraph 10
| Motion for a resolution | Amendment |
| 10. Points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite; | 10. Points out that, with regard to the rapid commercialisation of food biotechnology, clinical and pre-clinical studies are fundamental prerequisite, as well as a proper assessment of social, ethical, economic, environmental and cultural aspects of food innovation; inical and pre-clinical studies are fundamental prerequisite, as well as a proper assessment of social, ethical, economic, environmental and cultural aspects of food innovation; |
Or. en
Amendment 166
Sigrid Friis
Motion for a resolution
Paragraph 10
| Motion for a resolution | Amendment |
| 10. Points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite; | 10. Points out that, to better streamline regulatory pathways and allow for a more efficient time to market of food biotech, regulatory sandboxes looking into pre-market authorisation procedures, such as early tastings and confidential and dossier specific pre-submission consultations with food safety authorities, are an important prerequisite; |
Or. en
Amendment 167
Morten Løkkegaard, Sigrid Friis, Christophe Grudler, Jeannette Baljeu, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 10
| Motion for a resolution | Amendment |
| 10. Points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite; | 10. Underlines the need to maximise the potential of the food biotech system, whilst maintaining high levels of environmental, food and consumer safety; Points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite; |
Or. en
Amendment 168
Anthony Smith
Motion for a resolution
Paragraph 10
| Motion for a resolution | Amendment |
| 10. Points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite; | 10. Points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite; recalls the necessary respect of the precautionary principle in the context of the production and commercialisation of food biotechnology; |
Or. en
Amendment 169
Carlo Ciccioli
Motion for a resolution
Paragraph 10
| Motion for a resolution | Amendment |
| 10. Points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite; | 10. Points out that, with regard to the commercialisation of food biotechnology, clinical and pre-clinical studies are a fundamental prerequisite, as well as a proper assessment of social, ethical, economic, environmental and cultural aspects of food innovation; |
Or. en
Amendment 170
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 10
| Motion for a resolution | Amendment |
| 10. Points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite; | 10. Stresses the importance of appropriate regulatory procedures for food biotechnology; points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite; |
Or. en
Amendment 171
Letizia Moratti
Motion for a resolution
Paragraph 10
| Motion for a resolution | Amendment |
| 10. Points out that, with regard to the rapid commercialisation of food biotechnology, early tastings are an important prerequisite; | 10. Points out that comprehensive clinical and pre-clinical studies are an essential prerequisite for the rapid commercialisation of food biotechnology; |
Or. en
Amendment 172
Carlo Ciccioli
Motion for a resolution
Paragraph 10 a (new)
| Motion for a resolution | Amendment |
| 10 a. Underlines that an enabling, science-based framework for plants obtained through certain New Genomic Techniques is a valuable step for the development and adoption of this technology to support EU agriculture; |
Or. en
Amendment 173
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 11
| Motion for a resolution | Amendment |
| 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; | 11. Underlines that biosecurity risks must be addressed in conjunction with biotechnology and biomanufacturing innovation, ensuring framing responsible access to and use of synthetic biology tools, genetic editing technologies and biological materials; therefore calls for a robust ethical governance framework including the establishment of mandatory EU screening standards for the purchase of synthetic nucleic acids and benchtop synthesis equipment, including systems to verify the identity of the buyer and to assess the purpose and safety of the order; calls for the Commission to engage with industry and civil society to develop such screening standards; considers that screening should be mandatory and a pre-requisite for recipients of EU funding; calls for increased international cooperation with the goal of urgently supporting the development of international screening standards; |
Or. en
Amendment 174
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin
Motion for a resolution
Paragraph 11
| Motion for a resolution | Amendment |
| 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; | 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; calls for the establishment of an EU biosecurity registry for synthetic DNA and genetic engineering tools, improving transparency and risk assessment mechanisms; stresses the importance of EU strategic autonomy in biotech supply chains, ensuring that critical biomanufacturing inputs and expertise remain within Europe; urges stronger international cooperation on biosecurity standards, ensuring that EU-based biotech companies comply with global best practices while maintaining competitiveness; |
Or. en
Amendment 175
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Paragraph 11
| Motion for a resolution | Amendment |
| 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; | 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; recalls that biosafety considerations must also encompass the bioethical risks associated with human intervention in living systems, notably those related to the manipulation of genetic material, research on embryos, and germline modification; calls for an objective, evidence-based assessment of the potential benefits associated with new genomic techniques (NGTs); |
Or. en
Amendment 176
Marcin Sypniewski
Motion for a resolution
Paragraph 11
| Motion for a resolution | Amendment |
| 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; | 11. Underlines that biosecurity and public health risks must be addressed in parallel with innovation in biotechnology and biomanufacturing. Emphasises the need for ethical treatment of biological materials, especially those of human origin. Human gametes and embryos must never be treated as industrial inputs and must be protected by strong legal safeguards. Calls for clear EU-level guidance to ensure respect for dignity, informed consent and individual rights, while fully upholding the principles of subsidiarity and precaution in bioethical matters; |
Or. en
Amendment 177
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 11
| Motion for a resolution | Amendment |
| 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; | 11. Underlines that biosecurity risks are a reality that must be addressed in biotechnology and biomanufacturing innovation; Calls on the Comission to ensure responsible and ethical access to and use of synthetic biology tools, genetic editing technologies and biological materials, while fully applying the precautionary principle; Stresses that proper assessments are needed before authorising the access to the market, with particular care given to the potential releases into the environment; |
Or. en
Amendment 178
Adam Jarubas
Motion for a resolution
Paragraph 11
| Motion for a resolution | Amendment |
| 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; | 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; stresses that bacteriophage technologies, especially engineered or synthetic variants, must be integrated into EU dual-use frameworks, biosafety oversight, and pandemic/biothreat preparedness infrastructure; |
Or. en
Amendment 179
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 11
| Motion for a resolution | Amendment |
| 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; | 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; calls on the Commission to ensure that sensitive data is adequately protected and aligned with the EU’s data protection laws; |
Or. en
Amendment 180
Anthony Smith
Motion for a resolution
Paragraph 11
| Motion for a resolution | Amendment |
| 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; | 11. Underlines that biosecurity risks, including ethical concerns, 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; stresses the need to fully respect the precautionary principle in this context; |
Or. en
Amendment 181
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 11
| Motion for a resolution | Amendment |
| 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; | 11. Underlines that biosecurity risks must be addressed in conjunction with biotechnology and biomanufacturing innovation, ensuring responsible and bioethical access to and use of synthetic biology tools, genetic editing technologies and biological materials, taking into account the need for monitoring to assess their medium and long-term impact ; |
Or. en
Amendment 182
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Paragraph 11 – subparagraph 1 (new)
| Motion for a resolution | Amendment |
| calls on the Commission to ensure that the legislative proposal on biotechnology is in line with the principles enshrined in the Charter of Fundamental Rights, such as the respect for life and the protection of human dignity, and to guarantee that all efforts in the fields of innovation and regulatory simplification remain compatible with the highest standards of human dignity and public health; stresses that any restrictive measure adopted by a Member State on bioethical grounds — whether concerning the use of genetic engineering, synthetic biology, or the manipulation of sensitive biological material — must not be regarded as an obstacle to the integration of the internal market or to industrial development, but rather as the legitimate expression of a national constitutional identity, public order, and sovereign ethical choices, in accordance with Union law and the principle of subsidiarity; supports a regulatory approach based on the precautionary principle and a commitment to high ethical standards, in contrast with the product-based, innovation-driven frameworks observed in the United States, and the state-led and evolving regulatory environment in China; |
Or. en
Amendment 183
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 11 a (new)
| Motion for a resolution | Amendment |
| 11 a. Asks the Commission to prepare a study on a biological materials regulation; urges the Commission to present an updated Communication and an Action Plan on CBRN risks, in particular regarding bioterrorism and bio-risks; |
Or. en
Amendment 184
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 12
| Motion for a resolution | Amendment |
| 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; | 12. Underlines the importance for supply chain security of having a sufficient supply of raw materials, feedstock, such as sustainable biomass, and crucial components, such as enzymes, for biotechnology and biomanufacturing companies; calls for potential risks to be monitored while safeguarding company-sensitive data and the functioning of the internal market; considers that attention should be paid to self-sufficiency and the development of EU raw material value chains and manufacturing; furthermore, considers that strategic partnerships and cooperation with third countries is important for securing access to essential raw materials and sustainable feedstock; |
Or. en
Amendment 185
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 12
| Motion for a resolution | Amendment |
| 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; | 12. Underlines the importance for supply chain security of having a sufficient sustainably sourced feedstock supply for biotechnology and biomanufacturing companies while maintaining the high security safety and ethical standards, within the planetary boundaries; underlines that the best feedstock is waste, specifically bio-based biodegradable and compostable products, as it has minimal impact on biodiversity and promotes circularity; calls for a proper assessment of the impact of the use of feedstock on climate, biodiversity and food security, with due regard to low ILUC solutions; calls for potential risks to be monitored while safeguarding company-sensitive data and the functioning of the internal market; |
Or. en
Amendment 186
Carlo Ciccioli
Motion for a resolution
Paragraph 12
| Motion for a resolution | Amendment |
| 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; | 12. Underlines the importance for supply chain security of having a competitive, stable and reliable supply of feedstock and raw materials for biotechnology and biomanufacturing companies; calls for potential risks to be monitored while safeguarding company-sensitive data and the functioning of the internal market; underlines the importance of strategic partnerships with like-minded countries to secure access to essential raw materials and sustainable feedstock necessary to the growth of the biotech and biomanufacturing industries in the EU; |
Or. en
Amendment 187
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 12
| Motion for a resolution | Amendment |
| 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; | 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; underlines the importance of strategic partnerships with like-minded countries to secure access to feedstocks, raw materials and components to the growth of the biotech and biomanufacturing industries in the EU; |
Or. en
Amendment 188
Dimitris Tsiodras
Motion for a resolution
Paragraph 12
| Motion for a resolution | Amendment |
| 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; | 12. Underlines the importance for supply chain security of having a sufficient feedstock supply for biotechnology and biomanufacturing companies as well as with a thorough understanding of dependencies, starting materials and technological platforms; calls for these gaps and potential risks to be monitored while safeguarding company-sensitive data and the functioning of the internal market; |
Or. en
Amendment 189
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 12
| Motion for a resolution | Amendment |
| 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; | 12. Underlines the importance for supply chain security of having a sufficient feedstock, components, equipment, and hardware 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; |
Or. en
Amendment 190
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 12
| Motion for a resolution | Amendment |
| 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; | 12. Underlines the importance for supply chain security of having a sufficient feedstock and raw material 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; |
Or. en
Amendment 191
Niels Flemming Hansen
Motion for a resolution
Paragraph 12 a (new)
| Motion for a resolution | Amendment |
| 12 a. Stresses that, in an increasingly tense geopolitical context, the EU must fully leverage biotechnology and biomanufacturing to strengthen its strategic autonomy, reduce dependence on non-EU countries, and enhance food security; underlines that bio-based food systems can contribute to more resilient local economies by diversifying income sources, while typically requiring fewer natural resources, generating less pollution, and being less vulnerable to climate-related disruptions; |
Or. en
Amendment 192
Sigrid Friis
Motion for a resolution
Paragraph 12 a (new)
| Motion for a resolution | Amendment |
| 12 a. Underlines that the EU should maximise the benefits of biotech and biomanufacturing to ensure food security and decrease dependence from non-EU. Further underlines that bio-based food, especially plant-based food, typically requires fewer resources (e.g. land and water), is more environmentally and climate friendly, and less susceptible to climate change. |
Or. en
Amendment 193
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 12 a (new)
| Motion for a resolution | Amendment |
| 12 a. Calls on the Commission to include the principle of neighbour checks in existing and future legislation covering the biotechnology sector in order to ensure level playing for European biotech companies competing internationally and to learn from best practices from outside the EU; |
Or. en
Amendment 194
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 12 a (new)
| Motion for a resolution | Amendment |
| 12 a. Underlines the need to stimulate market demand and market uptake of bio-based products in Europe in order to increase the growth and competitiveness of the EU biotechnology and biomanufacturing sector; |
Or. en
Amendment 195
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 13
| Motion for a resolution | Amendment |
| 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; | 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; emphasizes that a well-articulated industrial strategy needs state support to incentivise R&D development calls for the need to develop a network of pre-commercial bioindustrial manufacturing facilities in Europe to provide researchers and founders access to infrastructure; asks to prioritise initiatives that follow theCERN modelof building start-up studios within research institutions, similar as well to the Berkeley-based Cyclotron Road programme; |
Or. en
Amendment 196
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 13
| Motion for a resolution | Amendment |
| 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; | 13. Notes that the scale-up and commercialisation of research results remains a big challenge in Europe; 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; calls for a common EU policy and strategic investments in technology infrastructures to facilitate the scaling up of prototypes and market uptake of innovative technology solutions; in this context, asks for a technology infrastructure pilot for biotechnology and biomanufacturing, essential for scaling up innovations; |
Or. en
Amendment 197
Anthony Smith
Motion for a resolution
Paragraph 13
| Motion for a resolution | Amendment |
| 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; | 13. Recalls the key role played by public research institutes and universities in developing the knowledge necessary for the development of biotechnologies; stresses that scientific breakthrough made in this context, as well as their potential commercial application, must remain in the public domain; 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; |
Or. en
Amendment 198
Adam Jarubas
Motion for a resolution
Paragraph 13
| Motion for a resolution | Amendment |
| 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; | 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; in that respect recommends the establishment of a coordinated EU biobanking infrastructure e.g. for phages and host-range genomic repository network to enable scalable, safe, and quality-controlled access to phage preparations across health, veterinary and environmental sectors; |
Or. en
Amendment 199
Carlo Ciccioli
Motion for a resolution
Paragraph 13
| Motion for a resolution | Amendment |
| 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; | 13. Stresses the need to improve the knowledge, public-private collaboration, and technology transfer between academia and industry to ensure EU-funded biotechnology and biomanufacturing research leads to commercial applications and industrial deployment and to foster competitive European biotech clusters; Invites the Commission to consider additional EU funding for universities with high technological transfers and spin-offs, in addition to existing funding; |
Or. en
Amendment 200
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 13
| Motion for a resolution | Amendment |
| 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; | 13. Stresses the need to improve the knowledge and technology transfer between academia and industry to ensure that EU-funded biotechnology and biomanufacturing research leads to commercial applications and industrial deployment; stresses that innovation cannot solely take place for short-term economic benefit, and that biotech innovation should be driven through a bottom-up approach under an independent Framework Programme for Research and Innovation; |
Or. en
Amendment 201
Margarita de la Pisa Carrión, Julie Rechagneux, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 13
| Motion for a resolution | Amendment |
| 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; | 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 in the Union, while also preventing third countries from exploiting European publications that, due to insufficient funding and legislative burden, fail to be developed within the Union; |
Or. en
Amendment 202
Eszter Lakos, Letizia Moratti
Motion for a resolution
Paragraph 13
| Motion for a resolution | Amendment |
| 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; | 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; in this context invites the Commission to support universities with large numbers of tech transfers and spin-offs; |
Or. en
Amendment 203
Diana Iovanovici Şoşoacă
Motion for a resolution
Paragraph 13
| Motion for a resolution | Amendment |
| 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; | 13. Stresses the need to improve the transfer of knowledge and technology between academia, the research sector and industry to ensure that EU-funded biotechnology and biomanufacturing research leads to commercial applications and industrial deployment across the EU of the best solutions as swiftly as possible; |
Or. ro
Amendment 204
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 13
| Motion for a resolution | Amendment |
| 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; | 13. Stresses the need to improve the transfer of knowledge, public-private collaboration, and technology between academia and industry to ensure that EU-funded biotechnology and biomanufacturing research leads to commercial applications and industrial deployment; |
Or. en
Amendment 205
Morten Løkkegaard, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 13 a (new)
| Motion for a resolution | Amendment |
| 13 a. Calls on the Commission to facilitate the creation of world-leading research hubs for biotechnology to drive innovation and collaboration between academia and industry and venture capital; |
Or. en
Amendment 206
Adam Jarubas
Motion for a resolution
Paragraph 13 a (new)
| Motion for a resolution | Amendment |
| 13 a. Underlines the importance of secure, standardized infrastructure to ensure responsible clinical application, AMR surveillance integration, and bioproduction readiness in emergency contexts. |
Or. en
Amendment 207
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 13 b (new)
| Motion for a resolution | Amendment |
| 13 b. Emphasizes the need for robust physical testing facilities in the biotechnology sector to drive innovation and facilitate the production and market access for SME’s and startups; |
Or. en
Amendment 208
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 14
| Motion for a resolution | Amendment |
| 14. Stresses the need to decrease energy prices and facilitate the process of validating large-scale industrial plants with large bioreactors; | 14. Stresses that affordable energy for everyone, e.g., as proposed within the Affordable Energy Action Plan, will also benefit the biotech sector; Considers important to make sure that permitting procedures are swift, especially for large-scale indsutrial plants such as bioreactors; Welcomes the latest revision of the Renewable Energy Directive acceleration, streamlining and simplification of permit-granting procedures for renewable energy projects and calls on Member States to implement those provisions as swiftly as possible; |
Or. en
Amendment 209
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera
Motion for a resolution
Paragraph 14
| Motion for a resolution | Amendment |
| 14. Stresses the need to decrease energy prices and facilitate the process of validating large-scale industrial plants with large bioreactors; | 14. stresses the need to ensure access to affordable and competitive energy for biotechnology and biomanufacturing operators, given the high energy intensity of large-scale biological production processes; calls on the Commission and the Member States to streamline and coordinate authorisation and validation procedures for industrial facilities using large bioreactors, in order to reduce administrative delays and support the deployment of biomanufacturing infrastructure across the Union; |
Or. en
Amendment 210
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 14
| Motion for a resolution | Amendment |
| 14. Stresses the need to decrease energy prices and facilitate the process of validating large-scale industrial plants with large bioreactors; | 14. Stresses the need to decrease energy prices and facilitate the process of validating large-scale industrial plants with large bioreactors necessary to break the cost barrier which in addition carry high construction and operating risks; |
Or. en
Amendment 211
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 14
| Motion for a resolution | Amendment |
| 14. Stresses the need to decrease energy prices and facilitate the process of validating large-scale industrial plants with large bioreactors; | 14. Stresses the need to decrease energy prices; |
Or. en
Amendment 212
Anthony Smith
Motion for a resolution
Paragraph 14
| Motion for a resolution | Amendment |
| 14. Stresses the need to decrease energy prices and facilitate the process of validating large-scale industrial plants with large bioreactors; | 14. Stresses the need to decrease energy prices ; calls on the phasing-out of biofuels; |
Or. en
Amendment 213
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 15
| Motion for a resolution | Amendment |
| 15. Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills; | 15. Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills; calls for collaboration among industry, research and civil society and for further measures to increase investment and focus on biotechnology and biomanufacturing education and professional training, to create and sustain high-quality jobs across the EU in the sector; considers that increasing investment and focus on STEM education, at secondary and tertiary levels is needed, as well as more public awareness of the biotechnology and biomanufacturing career opportunities to attract talent, especially more girls and women to the field; |
Or. en
Amendment 214
Anthony Smith
Motion for a resolution
Paragraph 15
| Motion for a resolution | Amendment |
| 15. Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills; | 15. Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills; calls on the right to training during working hours and at no cost for workers; calls on the full respect of strict occupational health and safety standards, especially in workplaces presenting biohazards; highlights the fact that good quality working conditions, decent wages, respect of collective agreements and trade unions’ right are essential to attract a skilled workforce in the sector; |
Or. en
Amendment 215
Diana Iovanovici Şoşoacă
Motion for a resolution
Paragraph 15
| Motion for a resolution | Amendment |
| 15. Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills; | 15. Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for support for, and the promotion of, entrepreneurial skills; stresses the need to adjust traditional educational programmes, as well as medium- and long-term training and retraining, to the rapid evolution of the biotechnologies sector, in order to meet the need for specialised staff and avoid potential disruptions in the labour market in this field; |
Or. ro
Amendment 216
Carlo Ciccioli
Motion for a resolution
Paragraph 15
| Motion for a resolution | Amendment |
| 15. Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills; | 15. Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills; calls on the Commission to look into best practices to support training and upskilling in biotechnology and biomanufacturing, fostering industry collaboration and offering targeted programs in areas as regulatory compliance, quality assurance and process engineering; |
Or. en
Amendment 217
Dimitris Tsiodras
Motion for a resolution
Paragraph 15
| Motion for a resolution | Amendment |
| 15. Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills; | 15. Highlights the need for concrete measures to ensure the further development of a skilled and diverse workforce across all EU Member States including among others, establishing Competence Centres providing expertise and skills, specific training actions such as upskilling and reskilling workers and incentives for public-private training initiatives; |
Or. en
Amendment 218
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin
Motion for a resolution
Paragraph 15
| Motion for a resolution | Amendment |
| 15. Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills; | 15. Underlines the need for a skilled European workforce in the biotechnology and biomanufacturing sector and for the promotion of entrepreneurial skills, in collaboration with industry; asks to reassess the potential of EU-US cooperation under the Trade and Economy Council and, should the situation arise, attract US researchers in the EU; |
Or. en
Amendment 219
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 15 a (new)
| Motion for a resolution | Amendment |
| 15 a. Points out that highly qualified individuals are available for hire today due to layoffs and restructuring undergone in third countries or political instability and erroneous management decisions that discourage employment in certain parts of the world. Welcomes the Commission’s Union of Skills and its plan to present the Visa Strategy, expand Marie Curie and Erasmus+ programmes, and develop Legal Gateway Offices, all of which aim to support the arrival of top talents, including students, researchers and trained workers from third countries; calls on the Commission to better implement existing legal frameworks such as the Blue Card Directive, the Students and Researchers Directive and the EU Long-term Residence Directive, all of which allow for mobility rights of third country nationals. To that regard, calls the Commission to build up on the EU Talent Pool initiative, as well as swift and facilitated visa procedures, together with the Member States to ensure efficient recruitment of high-skill third country nationals needed to support the development of digital society. |
Or. en
Amendment 220
Margarita de la Pisa Carrión, Julie Rechagneux, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 15 a (new)
| Motion for a resolution | Amendment |
| 15 a. Calls on the Commission, in line with the recommendations of the Draghi and Letta reports, to contribute to the creation of an attractive business environment that enables the creation of quality jobs in order to prevent brain drain and attract talent from third countries; |
Or. en
Amendment 221
Anthony Smith
Motion for a resolution
Paragraph 16
| Motion for a resolution | Amendment |
| 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; | 16. highlights that cross-border investment barriers need to be reduced to facilitate investment in biotechnology and biomanufacturing scale-ups; |
Or. en
Amendment 222
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 16
| Motion for a resolution | Amendment |
| 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; | 16. Calls for the urgent completion of the capital markets union to attract institutional investors to the relatively high-risk biotechnology and biomanufacturing industry, including venture capital, pension funds and private equity; calls for dedicated support for SMEs, start-ups and scale-ups ensuring they can compete globally and access the funding needed to scale up; highlights that cross-border investment barriers need to be reduced to facilitate investment in biotechnology and biomanufacturing scale-ups; |
Or. en
Amendment 223
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 16
| Motion for a resolution | Amendment |
| 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; | 16. Calls for the urgent completion of the capital markets union to attract institutional investors to the biotechnology and biomanufacturing industry, including venture capital and private equity; highlights that cross-border investment barriers need to be reduced to facilitate investment in biotechnology and biomanufacturing scale-ups; highlights that tax incentives on innovation and R&D plays a key role in investment decisions and that a more uniform EU approach is therefore needed; |
Or. en
Amendment 224
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin
Motion for a resolution
Paragraph 16
| Motion for a resolution | Amendment |
| 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; | 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; stresses that the cost of failure in the Union must be reduced to attract large-scale capital investments; |
Or. en
Amendment 225
Margarita de la Pisa Carrión, Julie Rechagneux, Paolo Borchia
Motion for a resolution
Paragraph 16
| Motion for a resolution | Amendment |
| 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; | 16. Notes that the capital markets union is still to be completed. Requests to the Commission to study measures like cutting red tape and simplification 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; |
Or. en
Amendment 226
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 16 a (new)
| Motion for a resolution | Amendment |
| 16 a. Urges the Commission to introduce dedicated calls and funding streams for biotech start-ups within Horizon Europe; calls for these programmes to specifically target early-stage companies, which are still far from market readiness and often face market failures; highlights that the biotech sector suffers from high attrition in early-stage innovation and that grants, guarantees and loans should continue to be directed only to excellent projects, capable of demonstrating strong scientific merit; |
Or. en
Amendment 227
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 16 b (new)
| Motion for a resolution | Amendment |
| 16 b. Notes that most innovative start-ups are acquired by larger laboratories; asks the Commission to explore what is hindering other exit strategies, such as IPOs, for new innovative firms to scale in the European Union; |
Or. en
Amendment 228
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 16 c (new)
| Motion for a resolution | Amendment |
| 16 c. Highlights that to stimulate demand for sustainable bio-based products over petro-chemicals ones, public procurement should prioritise quality and sustainability criteria in award procedure while introducing specific start-up quotas to encourage start-up participation in procurement and subcontracting; |
Or. en
Amendment 229
Anthony Smith
Motion for a resolution
Paragraph 17
| Motion for a resolution | Amendment |
| 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; | 17. 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; recalls that any public support to private entities in the sector should be made conditional for the respect of strict social conditionality, including respect of collective agreements, good working conditions and decent wages; stresses that companies receiving public funding shall not be allowed to distribute excessive dividends, resort to tax heavens, proceed with layoffs for economic reasons and shall reimburse public funding received in case of non-compliance with their obligations; recalls that companies that do not comply with labour law and health and safety regulations shouldn’t be able to benefit from direct public subsidies and should be excluded from public procurement tendering procedures; |
Or. en
Amendment 230
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 17
| Motion for a resolution | Amendment |
| 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; | 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 and increase the prospect that biotechnology IP stays in Europe; 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; calls for launching a biotechnology IPCEI for enabling mass production of bio-based chemicals, materials, and food/feed ingredients for de-risking large investments in first-mover industrial deployments; |
Or. en
Amendment 231
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Paragraph 17
| Motion for a resolution | Amendment |
| 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; | 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; stresses that the biotechnology and biomanufacturing sector in Europe is characterised by a high concentration of small and medium-sized enterprises (SMEs), in contrast to the more consolidated corporate structures observed in the United States and China; 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; |
Or. en
Amendment 232
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 17
| Motion for a resolution | Amendment |
| 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; | 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; underlines that biotech and biomanufacturing SMEs are critical for EU innovation leadership but face disproportionate barriers to securing capital; calls for a dedicated SME funding initiative to support biotechnology and biomanufacturing start-ups and scale-ups; |
Or. en
Amendment 233
Eszter Lakos, Letizia Moratti
Motion for a resolution
Paragraph 17
| Motion for a resolution | Amendment |
| 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; | 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; calls for the Commission to support existing and new biotechnology hubs across the EU; |
Or. en
Amendment 234
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 17
| Motion for a resolution | Amendment |
| 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; | 17. Notes that public-private partnerships and mission-driven EU investment strategies, such as the Circular Bio-based Europe Joint Undertaking, are important for de-risking biotechnology and biomanufacturing innovation; urges that EU investment instruments such as the InvestEU programme be strengthened to support biotechnology and biomanufacturing projects that have the potential for high positive impact; calls for a dedicated SME funding initiative to support biotechnology and biomanufacturing start-ups and scale-ups; |
Or. en
Amendment 235
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 17
| Motion for a resolution | Amendment |
| 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; | 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 financial high-risk biotechnology and biomanufacturing projects; calls for a dedicated SME funding initiative to support biotechnology and biomanufacturing start-ups and scale-ups; |
Or. en
Amendment 236
Marcin Sypniewski
Motion for a resolution
Paragraph 17
| Motion for a resolution | Amendment |
| 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; | 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; calls for the reinforcement and better promotion of existing EU instruments that support research and the development of bio-based products and biomanufacturing capacity, ensuring that funding is directed toward safe, ethical, and socially responsible innovation; |
Or. en
Amendment 237
Adam Jarubas
Motion for a resolution
Paragraph 17 a (new)
| Motion for a resolution | Amendment |
| 17 a. Calls for dedicated SME funding initiatives, administrative procedures, facilities and support, tailored to their coping capacities, to support bacteriophage therapy and bio-manufacturing ventures; recommends that phage-based technologies be explicitly included in EU innovation financing instruments, and benefit from tailored IP protections and market entry incentives, especially in areas of unmet medical need and AMR. |
Or. en
Amendment 238
Sigrid Friis
Motion for a resolution
Paragraph 17 a (new)
| Motion for a resolution | Amendment |
| 17 a. Calls on the Commission to include food biotechnologies and food biomanufacturing among the sectors listed in the EU taxonomy delegated act, in order to incentivise substantial investments toward these companies and support the EU’s efforts to expand sustainable investments. |
Or. en
Amendment 239
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 17 a (new)
| Motion for a resolution | Amendment |
| 17 a. Recommends to engage with civil society and citizens about the character, advantages and changes related to the increase of biotechnology and biomanufacturing based products, processes and services on the European market in order to improve public acceptance; |
Or. en
Amendment 240
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 17 a (new)
| Motion for a resolution | Amendment |
| 17 a. Notes that public awareness and public acceptance in the EU of biotechnology and biomanufactured products should be further strengthened; underlines the importance of collaboration between industry, academia and civil society in this context; |
Or. en
Amendment 241
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Bart Groothuis
Motion for a resolution
Paragraph 17 a (new)
| Motion for a resolution | Amendment |
| 17 a. Calls on the Commission to add biotechnologies and biomanufacturing in the list of sectors covered in the EU taxonomy delegated act, which would allow significant investment to be re-directed into biotech companies; |
Or. en
Amendment 242
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Paragraph 18
| Motion for a resolution | Amendment |
| 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; | 18. Stresses that, although Europe excels in process innovation, it continues to face difficulties in translating such innovations into industrial solutions and commercially viable products; highlights the fact that European public systems for R&D funding remain complex and insufficiently coordinated, resulting in duplications and inefficiencies; calls for a EU-wide approach involving all relevant stakeholders, including Member States, research institutions, universities, industrial actors, investors and innovation agencies, in order to coordinate public investments in research and development in the fields of biotechnology and biomanufacturing, with the dual objective of bridging the Union’s innovation and excellence gap and addressing the current absence of large-scale biomanufacturing infrastructures capable of competing with those established in the United States and China;" |
Or. en
Amendment 243
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 18
| Motion for a resolution | Amendment |
| 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; | 18. Highlights the fact that European public systems for R&D funding remain complex and insufficiently coordinated, resulting in duplications and inefficiencies; calls for strengthening pan-European collaboration and pooling of knowledge and resources, including leveraging public funding with private investments to tackle complex societal challenges; calls for an EU-wide approach to coordinate public investment in R&D for biotechnology and biomanufacturing in order to close the excellence, development and innovation gaps; |
Or. en
Amendment 244
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 18
| Motion for a resolution | Amendment |
| 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; | 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; underlines that industrial and environmental biotechnology, marine biotech, health biotech and agri-food biotech must all receive targeted support, such as Horizon Europe and the Framework Programme; |
Or. en
Amendment 245
Dimitris Tsiodras
Motion for a resolution
Paragraph 18
| Motion for a resolution | Amendment |
| 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; | 18. Highlights the fact that the European public systems for R&D funding remain complex and insufficiently coordinated, resulting in duplications and inefficiencies; similarly, recognises that off-patent R&D is currently inadequately supported and complex; calls for an EU-wide approach to coordinate public investment in R&D for biotechnology and biomanufacturing throughout product and innovation life-cycle, in order to close the excellence gap; |
Or. en
Amendment 246
Carlo Ciccioli
Motion for a resolution
Paragraph 18
| Motion for a resolution | Amendment |
| 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; | 18. Recalls the role of Framework Programmes, such as Horizon Europe, for fostering excellent science, technological development and innovation; 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; |
Or. en
Amendment 247
Eszter Lakos, Letizia Moratti
Motion for a resolution
Paragraph 18
| Motion for a resolution | Amendment |
| 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; | 18. Recalls the role of Framework Programmes, such as Horizon Europe, in fostering excellent science, technological development and innovation; 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; |
Or. en
Amendment 248
Anthony Smith
Motion for a resolution
Paragraph 18
| Motion for a resolution | Amendment |
| 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; | 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 to the benefit of European inhabitants and their needs in in order to close the excellence gap; |
Or. en
Amendment 249
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 18
| Motion for a resolution | Amendment |
| 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; | 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 bridge the innovation gap and ensure successful commercialization; |
Or. en
Amendment 250
Margarita de la Pisa Carrión, Julie Rechagneux, Barbara Bonte, Auke Zijlstra, Paolo Borchia, Pascale Piera
Motion for a resolution
Paragraph 18
| Motion for a resolution | Amendment |
| 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; | 18. Highlights the fact that European public systems for R&D funding remain complex and lack sufficient coordination and monitoring, 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; |
Or. en
Amendment 251
Diana Iovanovici Şoşoacă
Motion for a resolution
Paragraph 18 a (new)
| Motion for a resolution | Amendment |
| 18a. Highlights the importance of unitary patent protection for simplifying the procedure and enhancing patent protection at European level, for making prices more affordable for inventors (individuals, enterprises and research organisations) and for resolving disputes in this area for participating EU Member States; encourages Member States that have not joined the unitary patent system to do so as soon as possible in order to stimulate research, development and investment in innovation, thus helping to boost economic growth in the EU; |
Or. ro
Amendment 252
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 19
| Motion for a resolution | Amendment |
| 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; | 19. Highlights the role of Framework Programmes such as the current Horizon Europe, in fostering excellent science, technological development and innovation; 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; regrets that European private investments in research, development and innovation are lagging behind other major economies such as China and the USA; for more private investment in RDI to complement public funds and to close the innovation gap with the EU's competitors; notes that the scale-up and commercialisation of research results remains a big challenge in Europe; |
Or. en
Amendment 253
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Paragraph 19
| Motion for a resolution | Amendment |
| 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; | 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; insists nevertheless that, due to its sensitive nature, the biotechnology sector also requires a principle of ethical risk assessment to ensure a balanced approach between innovation and competitiveness, freedom of research, respect for human dignity, and the protection of populations; |
Or. en
Amendment 254
Letizia Moratti
Motion for a resolution
Paragraph 19
| Motion for a resolution | Amendment |
| 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; | 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; calls for thee creation of a framework that drives capital investments and promotes public private partnerships and reaserch centers; |
Or. en
Amendment 255
Anthony Smith
Motion for a resolution
Paragraph 19
| Motion for a resolution | Amendment |
| 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; | 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 "precautionary principle’ as a cross-sectorial principle for all EU funding; |
Or. en
Amendment 256
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 20
| Motion for a resolution | Amendment |
| 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; | 20. Notes the growing role of synthetic biology, bioinformatics and game-changing AI-driven biotechnology research; considers that the ethical use of AI, bioinformatics and synthetic biology is crucial to build trust and for society at large to benefit from these technologies; calls on biotech companies and researchers to use only advanced AI models that have undergone robust, external safety assessments; calls for companies integrating AI systems, especially in the health biotech sector, to prioritise data privacy and security, as well as, transparency, accountability and fairness in their AI algorithms; calls on the Commission to integrate ethical biotechnology and biomanufacturing innovation into the EU digital and AI strategies with clear, coherent, risk-based rules governing the use of AI in scientific research and manufacturing; |
Or. en
Amendment 257
Julie Rechagneux, Barbara Bonte, Margarita de la Pisa Carrión, Aleksandar Nikolic, Pascale Piera, Mélanie Disdier
Motion for a resolution
Paragraph 20
| Motion for a resolution | Amendment |
| 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; | 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; calls on the Commission to ensure that the Union’s digital and artificial intelligence strategies fully integrate the specific needs and opportunities related to innovation in biotechnology and biomanufacturing, including with regard to data governance, high-performance computing, and algorithmic transparency in the fields of health and life sciences; |
Or. en
Amendment 258
Marcin Sypniewski
Motion for a resolution
Paragraph 20
| Motion for a resolution | Amendment |
| 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; | 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, while simultaneously ensuring that the ethical implications of synthetic biology, bioinformatics, and AI-driven biotechnological applications are fully considered and appropriately regulated, with respect for fundamental rights and human dignity; |
Or. en
Amendment 259
Hildegard Bentele, Christian Ehler, Niels Flemming Hansen, Matej Tonin, Andrea Wechsler
Motion for a resolution
Paragraph 20
| Motion for a resolution | Amendment |
| 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; | 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, ensuring interoperability between biotechnology and biomanufacturing data infrastructure and AI-driven discovery platforms; |
Or. en
Amendment 260
Morten Løkkegaard, Jeannette Baljeu, Yvan Verougstraete, Christophe Grudler, Oihane Agirregoitia Martínez, Olivier Chastel, Katri Kulmuni, Bart Groothuis
Motion for a resolution
Paragraph 20
| Motion for a resolution | Amendment |
| 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; | 20. Notes the growing role data, 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; |
Or. en
Amendment 261
Damian Boeselager
on behalf of the Greens/EFA Group
Motion for a resolution
Paragraph 20 a (new)
| Motion for a resolution | Amendment |
| 20 a. Emphasises that future EU biotechnology and biomanufacturing strategies must be rooted in environmental justice, intergenerational equity, and strong public interest safeguards, ensuring democratic oversight and citizen participation in decision-making processes; |
Or. en
Amendment 262
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 20 a (new)
| Motion for a resolution | Amendment |
| 20 a. Notes that AI capabilities are dependent on the efficient use of data; considers that the creation of industrial data spaces for biotechnology and biomanufacturing and the adoption of biological data standards is important for efficient data sharing; |
Or. en
Amendment 263
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 20 b (new)
| Motion for a resolution | Amendment |
| 20 b. Acknowledges that while AI systems and quantum computing can significantly speed up research and lead to new innovations, enabling better computational designs of biological systems and faster means to engineer DNA and the genomes of organisms, they can also lower the barrier to biological threats; therefore calls for a robust governance framework to address these threats; |
Or. en
Amendment 264
Eero Heinäluoma, Bruno Tobback
Motion for a resolution
Paragraph 20 c (new)
| Motion for a resolution | Amendment |
| 20 c. Deplores that the recent bankruptcy of genealogy company will result in the sale of 15 millions of people’s genetic information, without prior consent of the individuals affected; |
Or. en