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

2.7.2025 A10-0123/1

Amendment 1

Viktória Ferenc, Kinga Gál, Enikő Győri, András Gyürk, György Hölvényi, András László, Pál Szekeres, Annamária Vicsek, Jorge Buxadé Villalba, Hermann Tertsch, Juan Carlos Girauta Vidal, Mireia Borrás Pabón, Margarita de la Pisa Carrión, Jorge Martín Frías, Afroditi Latinopoulou, Rachel Blom, Ton Diepeveen, Marieke Ehlers, Sebastian Kruis, Sebastiaan Stöteler, Auke Zijlstra, Elisabeth Dieringer, Gerald Hauser, Petra Steger, Harald Vilimsky, Georg Mayer, Roman Haider, Filip Turek, Jaroslav Bžoch, Klara Dostalova, Ondřej Knotek, Tomáš Kubín, Jana Nagyová, Jaroslava Pokorná Jermanová, Nikola Bartůšek, Anders Vistisen, Mathilde Androuët, Jordan Bardella, Christophe Bay, Marie-Luce Brasier-Clain, Marie Dauchy, Valérie Deloge, Mélanie Disdier, Anne-Sophie Frigout, Angéline Furet, Jean-Paul Garraud, Catherine Griset, France Jamet, Virginie Joron, Fabrice Leggeri, Thierry Mariani, Aleksandar Nikolic, Philippe Olivier, Gilles Pennelle, Pascale Piera, Pierre Pimpie, Julie Rechagneux, André Rougé, Julien Sanchez, Pierre-Romain Thionnet, Rody Tolassy, Matthieu Valet, Alexandre Varaut, Séverine Werbrouck, Csaba Dömötör, Ernő Schaller-Baross, Paolo Borchia, Susanna Ceccardi, Anna Maria Cisint, Aldo Patriciello, Silvia Sardone, Raffaele Stancanelli, Isabella Tovaglieri, Roberto Vannacci

Report A10-0123/2025

Hildegard Bentele

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

(2025/2008(INI))

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

2.7.2025 A10-0123/2

Amendment 2

Report A10-0123/2025

Hildegard Bentele

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

(2025/2008(INI))

Motion for a resolution

Recital S a (new)

Motion for a resolution	Amendment
	Sa. whereas such a framework and the ethical foundation of the EU 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 interests of science or industry, the prohibition of reproductive cloning and eugenic practices, the requirement of free and informed consent for any medical intervention, the prohibition of financial profit from the human body and its parts, the non-patentability of living human matter, and the rejection of discrimination based on genetic characteristics; whereas this must include, among other things, strict compliance with rules on genetically modified organisms (GMOs), the prohibition of certain biotechnological practices deemed incompatible with human dignity and characteristics of human species and sexes, safeguards concerning the prohibition of enhancement 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 and requirements for the protection of genetic data; whereas the Member States must retain the right to adopt more restrictive measures in the field of bioethics, without such measures being regarded as obstacles to the functioning of the internal market or to the development of the EU’s industrial strategy;

Or. en

2.7.2025 A10-0123/3

Amendment 3

Report A10-0123/2025

Hildegard Bentele

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

(2025/2008(INI))

Motion for a resolution

Paragraph 1

Motion for a resolution	Amendment
1. Emphasises the growth potential of the European biotechnology and biomanufacturing sector and the need for the EU to remain world-leading in this field; underlines the commitment to the principles of better regulation and lawmaking, simplification and administrative burden reduction; underlines that the simplification of EU legislation must not endanger any of the fundamental rights of citizens, workers and businesses or risk regulatory uncertainty; believes that any simplification proposal should not be rushed and proposed without proper consideration, consultation and impact assessments; therefore asks the Commission, if it proposes a new EU-wide regulation in the form of an EU biotech act, to address concrete gaps and shortcomings in current legislation and implementation, and to present legislation that can be revised, simplified, streamlined, repealed and which reduces bureaucratic burdens, focusing on the specificities of the industry and maintaining relevant safety and security standards; asks that an EU biotech act adopt a comprehensive cross-sectoral scope and that it be accompanied by an impact and cost assessment, competitiveness checks as well as a comprehensive assessment by the Regulatory Scrutiny Board, taking due consideration of the impact on SMEs, start-ups and scale-ups, as well as the interaction with other relevant legislative and non-legislative initiatives, including proposals currently undergoing the co-legislative procedure;	1. Emphasises the growth potential of the European biotechnology and biomanufacturing sector and the need for the EU to remain world leading in these fields; underlines the commitment to the principles of better regulation and lawmaking, simplification and administrative burden reduction; underlines the importance of always protecting the fundamental rights of citizens, workers and businesses; therefore asks the Commission, if a new EU-wide regulation in the form of an EU Biotech Act is proposed, to address concrete gaps and shortcomings in current legislation and implementation, and to present legislation that can be revised, simplified, streamlined, repealed or by which bureaucratic burden can be reduced, focusing on the specificities of the industry and maintaining relevant safety and security standards of quality and safety, while also being consistent with bioethics and human dignity; asks that an EU Biotech Act adopt a comprehensive cross-sectoral scope and that it be accompanied by an impact and cost assessment, competitiveness checks as well as a comprehensive assessment by the Regulatory Scrutiny Board, taking due consideration of the impact on SMEs, start-ups and scale-ups, as well as the interaction with other relevant legislative and non-legislative initiatives including proposals currently undergoing the co-legislative procedure; calls, in any case, 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 to or repeals of EU legislation, including those stemming from the European Green Deal;

Or. en

2.7.2025 A10-0123/4

Amendment 4

Report A10-0123/2025

Hildegard Bentele

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

(2025/2008(INI))

Motion for a resolution

Paragraph 8

Motion for a resolution	Amendment
8. Calls on the Commission to present a report on the implementation of current legislation in the field of biotechnology and biomanufacturing, including identifying potential gaps and regulatory barriers hampering the growth of the industries applying these technologies and manufacturing processes, including barriers to improving the EU’s self-sufficiency in key feedstocks, raw materials and components; recalls the precautionary principle laid down in Article 191 TFEU; urges the Commission to share with Parliament the preliminary findings of its study on regulatory burden, in this regard, and the potential need to review legislation related to biotechnology and biomanufacturing; calls for a simplification of current requirements for the sector across regulatory frameworks to enable faster approval procedures and market access, while maintaining a risk- and science-based approach and avoiding regulatory uncertainty;	8. Calls on the Commission to present a report on the implementation of current legislation in the field of biotechnology and biomanufacturing, including identifying potential gaps and regulatory barriers hampering the growth of the industries applying these technologies and manufacturing processes, including barriers to improving the EU’s self-sufficiency in key feedstocks, raw materials and components; recalls the precautionary principle in Article 191 TFEU; stresses, however, 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 a generator of unnecessary obstacles; urges the Commission, furthermore, to share with Parliament the preliminary findings of its study on regulatory burden and the potential need to review legislation related to biotechnology and biomanufacturing; calls for a simplification of current requirements for the sector across regulatory frameworks to enable faster approval procedures and market access, while maintaining a risk- and science-based approach and avoiding regulatory uncertainty; stresses, nevertheless, that such regulatory simplification must under no circumstances come at the expense of the Member States’ bioethics rules;

Or. en

2.7.2025 A10-0123/5

Amendment 5

Report A10-0123/2025

Hildegard Bentele

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

(2025/2008(INI))

Motion for a resolution

Paragraph 26 a (new)

Motion for a resolution	Amendment
	26a. Calls on the Commission to ensure that the proposal on biotechnology is in line with principles 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; insists that, due to its sensitive nature, the biotechnology sector 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