Skip to content
EU Parl Watch

amendment list, 17 June 2025

Public health aspects of biotechnology and life sciences

Document SANT-AM-774459 · (2025/2087(INI))

Committee on Public Health

On Parliament’s site PDF Word

Full text

Jump to an amendment (445)
Text 2,670 paragraphs

Amendment 1

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 1

Motion for a resolutionAmendment
– having regard to the Treaty on the Functioning of the European Union, in particular Articles 9, 151, 168, 173 and 179 thereof,– having regard to the Treaty on the Functioning of the European Union, in particular Articles 9, 13, 151, 168, 173, 179 and 191 thereof,

Or. en

Amendment 2

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 1

Motion for a resolutionAmendment
– having regard to the Treaty on the Functioning of the European Union, in particular Articles 9, 151, 168, 173 and 179 thereof,– having regard to the Treaty on European Union, in particular Articles 6, 8 and 21 thereof,

Or. en

Read the rest (2,658 paragraphs)

Amendment 3

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 2

Motion for a resolutionAmendment
– having regard to the Treaty on European Union, in particular Article 5(3) thereof and Protocol No 2 thereto on the application of the principles of subsidiarity and proportionality,– having regard to the Treaty on the Functioning of the European Union, and in particular Articles 4, 5, 6, 9, 114, 151, 153, 168, 169, 173, 179, and 191 thereof,

Or. en

Amendment 4

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 2 a (new)

Motion for a resolutionAmendment
– having regard to the Charter of Fundamental Rights of the European Union of 7 December 2000, as adapted on 12 December 2007 in Strasbourg, and in particular Articles 3, 8, and 35 thereof,

Or. en

Amendment 5

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Citation 2 b (new)

Motion for a resolutionAmendment
– having regard to the European Convention for the Protection of Human Rights and Fundamental Freedoms,

Or. en

Amendment 6

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Citation 2 c (new)

Motion for a resolutionAmendment
– having regard to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Convention on Human Rights and Biomedicine), signed in Oviedo on 4 April 1997,

Or. en

Amendment 7

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 2 d (new)

Motion for a resolutionAmendment
– having regard to the Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (CETS No. 168),

Or. en

Amendment 8

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 2 e (new)

Motion for a resolutionAmendment
– having regard to the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (CETS No. 195),

Or. en

Amendment 9

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 2 f (new)

Motion for a resolutionAmendment
– having regard to the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes (CETS No. 203),

Or. en

Amendment 10

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 3

Motion for a resolutionAmendment
– having regard to Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/28471 ,deleted
1 OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj.

Or. en

Amendment 11

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 3

Motion for a resolutionAmendment
– having regard to Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/28471 ,– having regard to Directive 2011/24/EU on the patients’ rights in cross-border healthcare,
1 OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj.

Or. en

Amendment 12

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Citation 3 a (new)

Motion for a resolutionAmendment
– having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC,

Or. en

Amendment 13

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Citation 3 d (new)

Motion for a resolutionAmendment
– having regard to Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on quality and safety standards for substances of human origin intended for human application, and repealing Directives 2002/98/EC and 2004/23/EC,

Or. en

Amendment 14

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 3 e (new)

Motion for a resolutionAmendment
– having regard to Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space, and amending Directive 2011/24/EU and Regulation (EU) 2024/2847,

Or. en

Amendment 15

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Citation 3 f (new)

Motion for a resolutionAmendment
– having regard to Regulation (EU) 2023/2854 of the European Parliament and of the Council of 13 December 2023 on harmonised rules for fair access to and use of data, and amending Regulation (EU) 2017/2394 and Directive (EU) 2020/1828 (Data Act),

Or. en

Amendment 16

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 4

Motion for a resolutionAmendment
– having regard to Regulation (EU) 2024/795 of the European Parliament and of the Council of 20 February 2024 establishing the Strategic Technologies for Europe Platform (STEP), and amending Directive 2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/2412 ,deleted
2 OJ L, 2024/795, 29.2.2024, ELI: http://data.europa.eu/eli/reg/2024/795/oj.

Or. en

Amendment 17

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 5 a (new)

Motion for a resolutionAmendment
– having regard to the Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (Text with EEA relevance),

Or. en

Amendment 18

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 5 a (new)

Motion for a resolutionAmendment
– having regard to Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes,

Or. en

Amendment 19

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou

Motion for a resolution

Citation 5 b (new)

Motion for a resolutionAmendment
– having regard to the Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (Text with EEA relevance),

Or. en

Amendment 20

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 5 b (new)

Motion for a resolutionAmendment
– having regard to the Commission communication of 25 July 2023 on the European Citizens’ Initiative (ECI) ‘Save cruelty-free cosmetics – Commit to a Europe without animal testing’ (COM(2023)5041),

Or. en

Amendment 21

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou

Motion for a resolution

Citation 5 c (new)

Motion for a resolutionAmendment
– having regard to the European Parliaments motion for resolution on EU action to combat antimicrobial resistance (2023/2703(RSP)),

Or. en

Amendment 22

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 5 c (new)

Motion for a resolutionAmendment
– having regard to the Commission communication of 11 December 2019 entitled ‘The European Green Deal’ (COM(2019)640),

Or. en

Amendment 23

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin

Motion for a resolution

Citation 5 d (new)

Motion for a resolutionAmendment
– having regard to the Commission proposal of 26 April 2023 for a Council recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach (COM(2023)0191),

Or. en

Amendment 24

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 5 d (new)

Motion for a resolutionAmendment
– having regard to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, adopted on 29 January 2000,

Or. en

Amendment 25

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 5 e (new)

Motion for a resolutionAmendment
– having regard to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity, adopted on 29 October 2010,

Or. en

Amendment 26

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 5 f (new)

Motion for a resolutionAmendment
– having regard to the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, adopted on 24 May 2024,

Or. en

Amendment 27

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 9

Motion for a resolutionAmendment
– having regard to the Commission communication of 29 January 2025 entitled ‘A Competitiveness Compass for the EU’ (COM(2025)0030),deleted

Or. en

Amendment 28

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Citation 9 a (new)

Motion for a resolutionAmendment
– having regard to the report "The Future of European Competitiveness" by Mario Draghi,

Or. en

Amendment 29

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 9 b (new)

Motion for a resolutionAmendment
– having regard to the report "Much More Than a Market" by Enrico Letta,

Or. en

Amendment 30

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 9 c (new)

Motion for a resolutionAmendment
– having regard to the report "Stronger together" on strengthening EU civil and military preparedness and readiness by Sauli Niinistö,

Or. en

Amendment 31

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 10

Motion for a resolutionAmendment
– having regard to the Commission Annual Report on European SMEs 2023/2024 of 4 July 2024,deleted

Or. en

Amendment 32

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 10 a (new)

Motion for a resolutionAmendment
– having regard to the report of the Scientific and Technological Options Assessment (STOA) panel, "Improving Access to Medicines and Promoting Pharmaceutical Innovation," November 2023 (PE 753.166),

Or. en

Amendment 33

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Citation 10 a (new)

Motion for a resolutionAmendment
– having regard to the Commission communication of 28 May 2025 entitled ‘The EU strategy for start-ups and scale-ups: Choosing the EU to start and grow’ COM (2025)270),

Or. en

Amendment 34

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 11

Motion for a resolutionAmendment
– having regard to the Universal Declaration on the Human Genome and Human Rights, adopted by UNESCO on 11 November 1997,– having regard to the 1948 Universal Declaration of Human Rights,

Or. en

Amendment 35

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Citation 11 a (new)

Motion for a resolutionAmendment
– having regard to the 2025 Concluding Observations on the European Union of the UN Committee on the Rights of Persons with Disabilities COM(2021)101,

Or. en

Amendment 36

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 11 a (new)

Motion for a resolutionAmendment
– having regard to the 1997 UNESCO Universal Declaration on the Human Genome and Human Rights,

Or. en

Amendment 37

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 11 b (new)

Motion for a resolutionAmendment
– having regard to the 2003 UNESCO International Declaration on Human Genetic Data,

Or. en

Amendment 38

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Citation 12

Motion for a resolutionAmendment
– having regard to the 2025 concluding remarks on the European Union of the UN Committee on the Rights of Persons with Disabilities,– having regard to the 2005 UNESCO Universal Declaration on Bioethics and Human Rights,

Or. en

Amendment 39

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Citation 12 a (new)

Motion for a resolutionAmendment
– having regard to the report of the UN Human Rights Committee Special Rapporteur on Cultural Rights, Farida Shaheed, on the right to enjoy the benefits of scientific progress and its applications (A/HRC/20/26),

Or. en

Amendment 40

Adam Jarubas

Motion for a resolution

Citation 12 a (new)

Motion for a resolutionAmendment
– having regard to availability, resilience of supply chains of essential and critical medicines, strategic autonomy, the Draghi Report and the Critical Medicines Act,

Or. en

Amendment 41

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 12 a (new)

Motion for a resolutionAmendment
– having regard to the Rathenau Institute's 2020 publication 'Data solidarity for health - Points for improvement with an eye on everyone's interests',

Or. en

Amendment 42

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Citation 12 a (new)

Motion for a resolutionAmendment
– having regard to the WHO guidelines on addressing key gender inequalities in the prevention, diagnosis and treatment of drug-resistant infections,

Or. en

Amendment 43

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Citation 12 b (new)

Motion for a resolutionAmendment
– having regard to the analysis by the Joint Research Centre (JRC) of 20 March 2024 on the global biotechnology innovation landscape, providing preliminary insights based on a patent analysis, as set out in the report entitled "Exploring the global landscape of biotech innovation: preliminary insights from patent analysis",

Or. en

Amendment 44

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Citation 12 b (new)

Motion for a resolutionAmendment
– having regard to the report of the UN Human Rights Committee Special Rapporteur on Cultural Rights, Alexandra Xanthaki, on the right to participate in science (A/HRC/55/44),

Or. en

Amendment 45

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Citation 12 b (new)

Motion for a resolutionAmendment
– having regard to the Rathenau Institute's 2021 publication 'Valuable use of human DNA data - Research into securing public values in the DNA data value chain',

Or. en

Amendment 46

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Citation 12 c (new)

Motion for a resolutionAmendment
– having regard to the 2025 concluding observations on the European Union by the United Nations Committee on the Rights of Persons with Disabilities,

Or. en

Amendment 47

Margarita de la Pisa Carrión

Motion for a resolution

Citation 14 a (new)

Motion for a resolutionAmendment
– having regard to the Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC,

Or. en

Amendment 48

Ignazio Roberto Marino

Motion for a resolution

Citation 14 a (new)

Motion for a resolutionAmendment
– having regard to the Commission communication of 25 July 2023 on the European Citizens’ Initiative (ECI) ‘Save cruelty-free cosmetics – Commit to a Europe without animal testing’, C(2023) 5041 final,

Or. en

Amendment 49

Elena Nevado del Campo, Dolors Montserrat

Motion for a resolution

Citation 14 a (new)

Motion for a resolutionAmendment
– having regard to the Draghi report on “the Future of European Competitiveness",

Or. en

Amendment 50

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital A

Motion for a resolutionAmendment
A. whereas biotechnology applies the principles and mechanisms intrinsic to biology to develop or modify products and processes for specific purposes, including in the healthcare and pharmaceutical sectors;A. whereas biotechnology applies the principles and mechanisms intrinsic to biology to develop or modify products and processes for specific purposes, including in healthcare and pharmaceutical sectors; whereas, according to the definition by the OECD, biotechnology 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;

Or. en

Amendment 51

András Tivadar Kulja

Motion for a resolution

Recital A

Motion for a resolutionAmendment
A. whereas biotechnology applies the principles and mechanisms intrinsic to biology to develop or modify products and processes for specific purposes, including in the healthcare and pharmaceutical sectors;A. whereas the OECD defines biotechnology as “the application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services”;

Or. en

Amendment 52

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Recital A

Motion for a resolutionAmendment
A. whereas biotechnology applies the principles and mechanisms intrinsic to biology to develop or modify products and processes for specific purposes, including in the healthcare and pharmaceutical sectors;A. whereas biotechnology is a multidisciplinary science that employs biological systems and processes to address scientific, technological, and healthcare challenges aimed at improving human health;

Or. en

Amendment 53

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Recital A a (new)

Motion for a resolutionAmendment
A a. whereas Advanced Therapy Medicinal Products (ATMPs) represent a strategic frontier in biotechnology, with the potential to address high unmet medical needs and redefine the treatment of severe and rare diseases, markedly enhance patient outcomes, and alleviate burdens on healthcare systems;

Or. en

Amendment 54

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Recital A b (new)

Motion for a resolutionAmendment
A b. whereas the EU’s leadership in research is not yet adequately matched by its capacity to translate scientific breakthroughs into therapies, due to structural barriers in early-stage development and short support for technology transfer and manufacturing scale-up;

Or. en

Amendment 55

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital B

Motion for a resolutionAmendment
B. whereas the sequencing of the DNA structure marked a pivotal moment in understanding human genetics and accelerating biotechnology development;B. whereas the sequencing of the DNA structure marked a pivotal moment in understanding human genetics and accelerating biotechnologies developments, paving the way for unprecedented advances in biotechnology, with transformative impacts on science, medicine and innovation;

Or. en

Amendment 56

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Recital B

Motion for a resolutionAmendment
B. whereas the sequencing of the DNA structure marked a pivotal moment in understanding human genetics and accelerating biotechnology development;B. whereas the sequencing of the DNA structure marked a pivotal moment in understanding human genetics and accelerating biotechnology development; whereas UNESCO adopted the Universal Declaration on the Human Genome to ensure ethical treatment, privacy protection, and the preservation of human dignity;

Or. en

Amendment 57

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Recital B

Motion for a resolutionAmendment
B. whereas the sequencing of the DNA structure marked a pivotal moment in understanding human genetics and accelerating biotechnology development;B. whereas the sequencing of DNA structure, along with the manipulation of stem cells and the emergence of gene-editing mechanisms, among other innovations, have transformed the capabilities for understanding human biology and accelerated the development of new fields of innovation to improve health;

Or. en

Amendment 58

Radan Kanev

Motion for a resolution

Recital B

Motion for a resolutionAmendment
B. whereas the sequencing of the DNA structure marked a pivotal moment in understanding human genetics and accelerating biotechnology development;B. whereas the sequencing of the human genome DNA structure marked a pivotal moment in understanding human genetics and accelerating biotechnology development;

Or. en

Amendment 59

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Recital B

Motion for a resolutionAmendment
B. whereas the sequencing of the DNA structure marked a pivotal moment in understanding human genetics and accelerating biotechnology development;B. whereas the sequencing of the human genome marked a pivotal moment in understanding human genetics and accelerating biotechnology development;

Or. en

Amendment 60

Laurent Castillo

Motion for a resolution

Recital B

Motion for a resolutionAmendment
B. whereas the sequencing of the DNA structure marked a pivotal moment in understanding human genetics and accelerating biotechnology development;B. whereas the sequencing of the human genome marked a pivotal moment in understanding human genetics and accelerating biotechnology development;

Or. fr

Amendment 61

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Recital B a (new)

Motion for a resolutionAmendment
B a. whereas human-centered non-animal methods are enabling personalised medicine strategies that would have been unimaginable with traditional animal models; whereas patient-derived systems—such as organoids, organ-on-chip platforms—and advanced in silico tools are particularly well-suited to study rare genetic conditions and to support the development of targeted therapies and more effective clinical trial designs;

Or. en

Amendment 62

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital B a (new)

Motion for a resolutionAmendment
B a. whereas recent scientific breakthroughs, such as the development of mRNA vaccines, have demonstrated the immense potential of biotechnology to respond rapidly and effectively to global health emergencies, as illustrated during the COVID-19 pandemic; whereas these innovations exemplify how advanced research can be swiftly translated into life-saving solutions with high societal impact;

Or. en

Amendment 63

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Recital B a (new)

Motion for a resolutionAmendment
B a. whereas biotechnology contributes significantly to better preparedness and response, following the One Health approach all hazards, by providing integrated and flexible tools and knowledge to monitor, prevent and treat diseases in the fields of human, animal and environmental health, including in the fight against antimicrobial resistance and unexpected emergencies;

Or. en

Amendment 64

Ruggero Razza

Motion for a resolution

Recital B a (new)

Motion for a resolutionAmendment
Ba. whereas the COVID-19 pandemic highlighted the importance of biotechnology for public health, in particular through genome sequencing of the SARS-CoV-2 virus, the swift development of mRNA vaccines and the production of high-precision diagnostic tools;

Or. it

Amendment 65

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Recital B b (new)

Motion for a resolutionAmendment
B b. whereas in response to the European Citizens’ Initiative (ECI) “Save cruelty-free cosmetics – Commit to a Europe without animal testing”, the Commission committed to developing a roadmap towards ultimately phasing out animal testing for chemical safety assessments, expected to be published at the beginning of 2026;

Or. en

Amendment 66

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Recital B b (new)

Motion for a resolutionAmendment
B b. whereas biotechnology covers the full spectrum of natural risks and threats, promoting coordination, efficiency and fostering capacity building, coordination and cooperation between Member States;

Or. en

Amendment 67

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital C

Motion for a resolutionAmendment
C. whereas biotechnology has been identified as a critical technology area for the EU;C. whereas biotechnology has been identified as a critical technology area for the EU; whereas investment in this field represents a strategic opportunity to reduce dependencies on other regions, strengthen Europe’s health sovereignty and build resilience in essential sectors; whereas the Union can build on its scientific excellence, world-class research institutions and dynamic innovation ecosystem to develop a competitive biotechnology sector that supports high-quality job creation, contributes to strategic autonomy, and reinforces the EU’s clinical, scientific and manufacturing leadership in a context of growing global technological competition;

Or. en

Amendment 68

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Recital C

Motion for a resolutionAmendment
C. whereas biotechnology has been identified as a critical technology area for the EU;C. whereas biotechnology has been identified as a critical technology area for the EU; whereas this sector has a significant impact on economic growth, attracts investment, and creates high-quality employment, thereby contributing to strengthening the EU’s global competitiveness; whereas a strong biotechnology sector is essential for responding to future health crises and plays a key role in ensuring food safety and quality, including through the detection of pathogens in food;

Or. en

Amendment 69

Elena Nevado del Campo, Dolors Montserrat

Motion for a resolution

Recital C

Motion for a resolutionAmendment
C. whereas biotechnology has been identified as a critical technology area for the EU;C. whereas biotechnology has been identified as a critical technology area for the EU, strategically positioning the sector as essential to the Union’s objective of achieving technological sovereignty and reducing its dependence on external sources for essential materials, particularly in active pharmaceutical ingredients (APIs); underlines that biotechnology is also a key driver to boost European competitiveness, innovation, and strategic autonomy;

Or. en

Amendment 70

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Recital C

Motion for a resolutionAmendment
C. whereas biotechnology has been identified as a critical technology area for the EU;C. whereas biotechnology has been identified as a critical technology area for the EU that could be important in enhancing EU strategic autonomy by reducing dependencies on third countries and ensuring availability of both generic and innovative medicines;

Or. en

Amendment 71

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Recital C

Motion for a resolutionAmendment
C. whereas biotechnology has been identified as a critical technology area for the EU;C. whereas biotechnology, as a field of research and technological development, is a strategic area within the public policies of the European Union;

Or. en

Amendment 72

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Recital C a (new)

Motion for a resolutionAmendment
C a. whereas the European Commission has recently announced its intention to present a proposal for the European Biotech Act in early 2026; whereas, in order to foster innovation and strengthen the competitiveness of the European biotechnology sector, the scope of this legislation should go beyond public health alone; stresses that the European Biotech Act should also cover other crucial areas such as energy, defence, agriculture, and climate mitigation and adaptation; stresses that the proposal should provide a comprehensive and integrated approach encompassing all key biotechnology sectors;

Or. en

Amendment 73

Dan-Ştefan Motreanu

Motion for a resolution

Recital C a (new)

Motion for a resolutionAmendment
C a. Recalls that changing geopolitical dynamics are accelerating the global race for technological leadership, including in the field of biotechnology, which will shape the global economy for decades to come; Stresses that the European biotechnology sector is at risk of falling behind if timely and appropriate measures are not adopted;

Or. en

Amendment 74

Aurelijus Veryga

Motion for a resolution

Recital C a (new)

Motion for a resolutionAmendment
C a. whereas the EU’s attractiveness as a global hub for clinical trials is in steady decline, and urgent measures are needed to simplify procedures, streamline cross–border coordination, and accelerate biotech innovation across the EU;

Or. en

Amendment 75

Jessica Polfjärd

Motion for a resolution

Recital C a (new)

Motion for a resolutionAmendment
C a. whereas resilient supply chains are critical for a strong biotechnology sector; whereas barriers to trade should be addressed to ensure a level playing field that supports innovation;

Or. en

Amendment 76

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Recital C b (new)

Motion for a resolutionAmendment
C b. whereas an analysis by the Joint Research Centre (JRC) of 20 March 2024 shows that biotechnology patents accounted for approximately 5% of all patent applications filed between 2001 and 2020; whereas the United States held a leading position in biotechnology patent development in 2020, accounting for 39% of the total, followed by the European Union with an 18% share, while China is rapidly gaining ground with a 10% share; whereas these figures highlight the importance of strengthening the European Union’s competitive position in the biotechnology sector;

Or. en

Amendment 77

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Recital D

Motion for a resolutionAmendment
D. whereas innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;D. whereas innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities and women; whereas four out of five individuals with an autoimmune disease are women, and women with cardiovascular conditions are often underdiagnosed and undertreated; whereas the holistic development of knowledge within the life sciences must systematically take into account the gender dimension and other relevant vulnerability factors, in order to achieve a better understanding of underlying causes and mechanisms;

Or. en

Amendment 78

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Recital D

Motion for a resolutionAmendment
D. whereas innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;D. whereas biotechnology is a key tool within a comprehensive approach to health policies, due to its ability to enhance and integrate key innovations in the healthcare system as a public service, as well as the opportunity to incorporate innovative therapies and improve the quality of healthcare, all contributing to the improvement of health for the entire citizenry of the Union;

Or. en

Amendment 79

Elena Nevado del Campo, Dolors Montserrat

Motion for a resolution

Recital D

Motion for a resolutionAmendment
D. whereas innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;D. whereas innovation in biotechnology adds societal value and can contribute to enhancing healthcare by developing advanced treatments, responding to health crisis and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;

Or. en

Amendment 80

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital D

Motion for a resolutionAmendment
D. whereas innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;D. whereas innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches; whereas innovations in biotechnology can be game changers for all patients, particularly those living with rare diseases and certain disabilities;

Or. en

Amendment 81

Margarita de la Pisa Carrión

Motion for a resolution

Recital D

Motion for a resolutionAmendment
D. whereas innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;D. whereas clinical research and innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;

Or. en

Amendment 82

Ignazio Roberto Marino

Motion for a resolution

Recital D

Motion for a resolutionAmendment
D. whereas innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;D. whereas clinical research and innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;

Or. en

Amendment 83

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Recital D

Motion for a resolutionAmendment
D. whereas innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;D. whereas innovation in biotechnology adds societal value and can contribute to enhancing global healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;

Or. en

Amendment 84

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Recital D

Motion for a resolutionAmendment
D. whereas innovation in biotechnology adds societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;D. whereas innovation in biotechnology could add societal value and can contribute to enhancing healthcare and improving the health of EU citizens, offering novel therapeutic tools and approaches, while ensuring the protection and care of the most vulnerable groups, including people with disabilities;

Or. en

Amendment 85

Ignazio Roberto Marino

Motion for a resolution

Recital D a (new)

Motion for a resolutionAmendment
D a. whereas biotechnology plays a crucial role in the development of new vaccines, as shown by the success of mRNA-based COVID-19 vaccines, which highlighted the effectiveness of biotech-driven solutions in responding to global health crises; whereas these innovations are essential to advancing a more prevention-focused healthcare model, centred on early intervention, screening, preparedness, and broad immunisation strategies;

Or. en

Amendment 86

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Recital D a (new)

Motion for a resolutionAmendment
D a. whereas integrating human, animal and environmental health under One Health approach into research and development strategies can enable the underlying causes of diseases to be identified and addressed more effectively by biotechnology-based treatments;

Or. en

Amendment 87

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Recital D a (new)

Motion for a resolutionAmendment
D a. whereas DNA data are special personal data that must be treated with extreme care, as DNA analysis is a form of 'intimate technology', or technology that can monitor, analyse and provide opportunities to influence our bodies and behaviour in many ways;

Or. en

Amendment 88

Viktória Ferenc, Margarita de la Pisa Carrión

Motion for a resolution

Recital D a (new)

Motion for a resolutionAmendment
D a. whereas a thriving EU biotech ecosystem is of strategic importance for the effectiveness of healthcare and the resilience of health systems during times of strain, such as public health emergencies, and for addressing challenges such as disease prevention;

Or. en

Amendment 89

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Recital D a (new)

Motion for a resolutionAmendment
D a. whereas scientific knowledge from which biotechnological applications arise stems from basic and preclinical research, which is mostly carried out by universities and research centres;

Or. en

Amendment 90

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital D a (new)

Motion for a resolutionAmendment
D a. whereas improving equitable access to these treatments is essential to ensure that all patients can benefit from biotechnological advances;

Or. en

Amendment 91

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Recital D b (new)

Motion for a resolutionAmendment
D b. whereas companies that generate significant economic value by obtaining, analysing and exploiting DNA data in many different ways encourage and entice citizens to share their DNA data, whereas this has created a complex, international value chain of DNA data, where regulation and oversight are increasingly fragmented and where the rights and interests of citizens are not properly safeguarded;

Or. en

Amendment 92

Ignazio Roberto Marino

Motion for a resolution

Recital D b (new)

Motion for a resolutionAmendment
D b. whereas innovation in biotechnology enhances disease prevention, diagnosis, and treatment, and offers significant advances in the management of chronic, rare, autoimmune, and metabolic diseases, thereby contributing to more resilient and sustainable healthcare systems across Europe;

Or. en

Amendment 93

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Recital D b (new)

Motion for a resolutionAmendment
D b. whereas it is the responsibility of public authorities both to promote research activities and to encourage the development of applications that contribute to advancing solutions for the benefit of human health;

Or. en

Amendment 94

Viktória Ferenc, Margarita de la Pisa Carrión

Motion for a resolution

Recital D b (new)

Motion for a resolutionAmendment
D b. whereas in 2018, healthcare biotech’s total direct GDP contribution was EUR 29.031.0 billion, and the sector contributed to over 175210,000 direct jobs in the EU1a;
1a [1] EU27 adjusted values, EuropaBio study: “Measuring the economic footprint of the biotechnology industry in Europe”, December, 2020, https://www.europabio.org/wpcontent/uploads/2021/02/201208_WifOR_EuropaBIO_Economic_Impact_Biotech_FINAL.pdf

Or. en

Amendment 95

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Recital D c (new)

Motion for a resolutionAmendment
D c. whereas adequate protection of the conditions under which research is conducted is crucial for the development of biotechnological research—covering labor and professional conditions, access to and continuation of academic and educational progression, as well as scholarships, internships, and the incorporation of a gender perspective in access to and promotion within academic careers, especially in STEM fields;

Or. en

Amendment 96

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Recital D c (new)

Motion for a resolutionAmendment
D c. whereas the amount and demand of DNA data is constantly increasing, DNA data are increasingly outsourced to (semi-)private laboratories and are increasingly analysed at foreign laboratories, whereas DNA data are concentrated in certain countries or by large commercial parties;

Or. en

Amendment 97

Viktória Ferenc, Margarita de la Pisa Carrión

Motion for a resolution

Recital D c (new)

Motion for a resolutionAmendment
D c. whereas it is estimated that 6000 - 8000 distinct rare diseases affect between 27 and 36 million EU citizens and biotechnology plays a vital role in advancing rare disease research and development, offering new diagnostic tools and therapeutic approaches1b;
1b https://research-and-innovation.ec.europa.eu/research-area/health/rare-diseases_en

Or. en

Amendment 98

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Recital D d (new)

Motion for a resolutionAmendment
D d. whereas biotechnology must be developed in accordance with the highest standards for the protection of fundamental rights, and taking into account that its development involves extensive use of highly sensitive data—both through the large-scale use of health data and medical records for developments such as those based on artificial intelligence, and due to the sensitivity of data used in many bioengineering applications—therefore, the architecture for the design, collection, processing, and sharing of data must be guided by the fundamental rights recognized in the Charter of Fundamental Rights of the European Union, the European Convention on Human Rights, and the common constitutional traditions of the Member States, in their objective dimension;

Or. en

Amendment 99

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Recital D d (new)

Motion for a resolutionAmendment
D d. whereas there is speculation that companies dealing with DNA data are seeking a data monopoly, and whereas international digital platforms, such as Google, Amazon and Microsoft play a dominant role in this, as they provide storage and computational capacity for complex data analysis with DNA data, such as with machine learning and deep learning; whereas this is creating an excessive technological dependency on such big-tech companies to gain insights from DNA data;

Or. en

Amendment 100

Viktória Ferenc, Margarita de la Pisa Carrión

Motion for a resolution

Recital D d (new)

Motion for a resolutionAmendment
D d. whereas the attractiveness of Europe as a location for conducting clinical trials has been in decline in the recent years, and as a result the EU has been losing global share to the United States and China, which has doubled its number of commercial trials;

Or. en

Amendment 101

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Recital D e (new)

Motion for a resolutionAmendment
D e. whereas the principle of equal treatment and non-discrimination in the medical field requires particular vigilance when automated decision-making, diagnostic, or evaluation mechanisms are incorporated—whether in administrative or medical decisions—and therefore, the use of AI and automated decision-making must be implemented in a manner that prevents both direct and indirect discriminatory outcomes, through explicit legal protection of individuals against multiple and interconnected forms of discrimination in all areas of life, including discrimination based on disability and age, gender, sex, sexual orientation, religion, beliefs, ethnic origin, migration status, nationality, and economic situation;

Or. en

Amendment 102

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Recital D e (new)

Motion for a resolutionAmendment
D e. whereas public values and human rights such as privacy, autonomy, security and justice may come under pressure in a future where DNA data plays an increasing role;

Or. en

Amendment 103

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Recital D f (new)

Motion for a resolutionAmendment
D f. whereas experts point out1a that big-data analyses too often lead to very general conclusions that offer little or no additional course of action for treating physicians compared to what they already knew about the patient in question, whereas in contrast, targeted research with smaller datasets, where the data are of good quality and applicable to the relevant medical context, provide much more important insights for public health, and that these insights are more valuable than hypothesis-free crunching of more and more DNA data;
1a Rathenau Institute (2020). Data solidarity for health - Points for improvement with an eye to everyone's interests. The Hague (authors: Gerritsen, J. & P. Verhoef).

Or. en

Amendment 104

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Recital D f (new)

Motion for a resolutionAmendment
D f. whereas accessibility to innovative treatments must be universal, biotechnology should be made available to all citizens of the Union, regardless of their place of residence, socioeconomic status, or any other factors that may affect their access to healthcare services. This should entail the development of a fast, simplified, and effective cross-border healthcare system for innovative therapies that, due to their nature, the potential number of patients benefiting, cost, and/or access conditions, cannot be made available in all Member States;

Or. en

Amendment 105

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Recital E

Motion for a resolutionAmendment
E. whereas deepening our knowledge of life sciences can drive innovation in biotechnology, particularly in the pharmaceutical industry;E. whereas biotechnological applications have increasing uses in the field of health and in the production of healthcare products for human health, including recombinant proteins—used, for example, in the in vitro production of insulin as well as monoclonal antibodies, interferons, and interleukins, among others;

Or. en

Amendment 106

Elena Nevado del Campo, Dolors Montserrat

Motion for a resolution

Recital E

Motion for a resolutionAmendment
E. whereas deepening our knowledge of life sciences can drive innovation in biotechnology, particularly in the pharmaceutical industry;E. whereas deepening our knowledge of life sciences can drive innovation in biotechnology, particularly in the pharmaceutical industry; supporting faster and more efficient research and development (R&D), fostering a globally competitive European innovation ecosystem, and ultimately enabling timely and equitable patient access to safe and effective treatments;

Or. en

Amendment 107

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital E

Motion for a resolutionAmendment
E. whereas deepening our knowledge of life sciences can drive innovation in biotechnology, particularly in the pharmaceutical industry;E. whereas innovation in biotechnology is often driven by progress in life sciences, with breakthroughs in one area, such as healthcare, enabling cross-sectoral applications in fields including agriculture, environmental technologies and beyond;

Or. en

Amendment 108

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Recital E

Motion for a resolutionAmendment
E. whereas deepening our knowledge of life sciences can drive innovation in biotechnology, particularly in the pharmaceutical industry;E. whereas deepening our knowledge and promoting the exchange of expertise in the life sciences between educational institutions and EU Member States can drive innovation in biotechnology, particularly in the pharmaceutical industry;

Or. en

Amendment 109

Aurelijus Veryga

Motion for a resolution

Recital E

Motion for a resolutionAmendment
E. whereas deepening our knowledge of life sciences can drive innovation in biotechnology, particularly in the pharmaceutical industry;E. whereas deepening our knowledge of life sciences can drive innovation in biotechnology, particularly within universities, public hospitals, and the pharmaceutical industry;

Or. en

Amendment 110

Laurent Castillo

Motion for a resolution

Recital E

Motion for a resolutionAmendment
E. whereas deepening our knowledge of life sciences can drive innovation in biotechnology, particularly in the pharmaceutical industry;E. whereas deepening our knowledge of life sciences can drive innovation in biotechnology for both the public and private sectors, fostering partnerships with one another;

Or. fr

Amendment 111

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Recital E a (new)

Motion for a resolutionAmendment
E a. biotechnology strengthens the development of biological manufacturing processes that produce sustainable alternatives to synthetic chemicals, reducing environmental pollution and its negative impact on human and animal health. The role of biotechnology, following the One Health approach, is multifaceted and multisectoral, covering various challenges and improving the Union’s capacity to protect the health of all living beings and the environment;

Or. en

Amendment 112

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Recital E a (new)

Motion for a resolutionAmendment
E a. whereas antimicrobial resistance (AMR) is an increasingly serious threat to public health in the EU and worldwide, with an estimated 1.27 million deaths directly attributable to AMR in 2019; whereas targeted investments in life sciences research and biotechnological innovation are essential for the development of new antimicrobial agents, rapid and accurate diagnostics, and preventive strategies such as vaccine development;

Or. en

Amendment 113

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Recital E a (new)

Motion for a resolutionAmendment
E a. whereas biopiracy is defined1a as the unauthorised extraction of biological resources and/or associated traditional knowledge from developing countries, or the patenting of spurious inventions based on such knowledge or resources without compensation, whereas this has been and continues to be a widespread phenomenon, leading to excessive profits for big companies without any sharing of the benefits;
1a Robinson D. Confronting Biopiracy: Challenges, Cases and International Debates. Oxfordshire, UK: Taylor and Francis; 2010.

Or. en

Amendment 114

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Recital E a (new)

Motion for a resolutionAmendment
E a. whereas biotechnology holds significant potential for development in the field of personalized medicine, such as tailoring treatments and preventing adverse effects, and that this potential should be harnessed to strengthen the preventive approach of our healthcare systems, in the interest of both promoting health and enhancing the efficiency of the healthcare systems of the Member States;

Or. en

Amendment 115

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Recital E b (new)

Motion for a resolutionAmendment
E b. whereas co-infection in viral infections and respiratory diseases is a common and serious phenomenon, and infectious agents - including viruses, bacteria, and fungi - can significantly increase the severity of illness when occurring simultaneously with viral pathogens such as SARS-CoV-2; whereas co-infections during health crises such as the COVID-19 pandemic have led to increased mortality, complications in diagnosis and treatment, and additional pressure on healthcare systems; whereas life sciences research and biotechnological innovations are crucial for the development of rapid diagnostic methods, appropriate therapeutic interventions, and improved monitoring strategies to detect and manage co-infections;

Or. en

Amendment 116

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Recital E b (new)

Motion for a resolutionAmendment
E b. whereas is it crucial that public goods, including genetic resources, lead to public, instead of only private profits, that resources and knowledge of indigenous peoples are protected against robbery by companies, and that benefits are equally and fairly shared;

Or. en

Amendment 117

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Recital E b (new)

Motion for a resolutionAmendment
E b. whereas biotechnology applied to diagnostics—through integrated AI, biosensors, or nanotechnology—has the potential to offer even greater precision and to enhance medical decision-making for the benefit of patients' health;

Or. en

Amendment 118

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Recital E c (new)

Motion for a resolutionAmendment
E c. whereas reproductive and prenatal biotechnology warrants special attention within diagnostic and therapeutic possibilities, particularly in relation to therapeutic models that are not yet available but hold great potential for improving treatment options for a wide range of currently complex diseases, such as in utero gene therapy;

Or. en

Amendment 119

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Recital E c (new)

Motion for a resolutionAmendment
E c. whereas the European Commission, through the Health Emergency Preparedness and Response Authority (HERA), with financial support from the European Investment Bank (EIB), can provide an incentive to start-ups and scale-ups to bring innovations to the market more quickly and efficiently;

Or. en

Amendment 120

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Recital E d (new)

Motion for a resolutionAmendment
E d. whereas rare diseases in the European Union are defined as conditions affecting no more than 1 in 2,000 people; whereas it is estimated that there are between 6,000 and 8,000 different rare diseases affecting approximately 36 million people in the EU; whereas rare diseases are recognized across the EU and worldwide as an urgent public health challenge; whereas around 80% of these conditions have a genetic origin, and the limited number of patients per disease results in a lack of investment in research and development; whereas in 2018, 25 EU Member States had established national action plans for rare diseases, 19 of which were time-limited; whereas many of these plans have since become outdated, with end dates dating back to 2020, 2018, or even 2013;

Or. en

Amendment 121

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital F

Motion for a resolutionAmendment
F. whereas the EU leads in scientific publications in biotechnology5 , but struggles to turn research into market solutions;F. whereas the EU leads in scientific publications in biotechnology, yet faces persistent challenges in translating research breakthroughs into innovative medical products and commercially viable solutions, due in part to obstacles in early-stage development, limited access to scientific and regulatory guidance, fragmentation of clinical trial processes and insufficient support for manufacturing scale-up;
5 Evers, M., a Stein-Asmussen, A., Szlezak, N., Zemp, A., ‘Europe’s Bio Revolution: Biological innovations for complex problems’, McKinsey & Company, January 2023.

Or. en

Amendment 122

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Recital F

Motion for a resolutionAmendment
F. whereas the EU leads in scientific publications in biotechnology5 , but struggles to turn research into market solutions;F. whereas the EU leads in scientific publications in biotechnology5 , but struggles to turn research into market solutions, with EU’s global share of drug R&;D having decreased from 49.1% to 29% ;
5 Evers, M., a Stein-Asmussen, A., Szlezak, N., Zemp, A., ‘Europe’s Bio Revolution: Biological innovations for complex problems’, McKinsey & Company, January 2023.5 Evers, M., a Stein-Asmussen, A., Szlezak, N., Zemp, A., ‘Europe’s Bio Revolution: Biological innovations for complex problems’, McKinsey & Company, January 2023.

Or. en

Amendment 123

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Recital F

Motion for a resolutionAmendment
F. whereas the EU leads in scientific publications in biotechnology5 , but struggles to turn research into market solutions;F. whereas universities and research centres in the Union, most of which are publicly owned, possess strong research capabilities in the field of biotechnology, leading in scientific publications;
5 Evers, M., a Stein-Asmussen, A., Szlezak, N., Zemp, A., ‘Europe’s Bio Revolution: Biological innovations for complex problems’, McKinsey & Company, January 2023.

Or. en

Amendment 124

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Recital F a (new)

Motion for a resolutionAmendment
F a. whereas the freedom of scientific research, as enshrined in Article 13 of the Charter of Fundamental Rights of the European Union, is a fundamental principle of the Union; whereas respect for academic freedom is essential for independent, ethical, and responsible research in the fields of biotechnology and the life sciences, with particular attention to public health;

Or. en

Amendment 125

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Recital F a (new)

Motion for a resolutionAmendment
F a. whereas the EU has led for the last two decades on the development of the scientific and regulatory principles, R&D and manufacturing evolution for biosimilar medicines, contributing to the availability, accessibility and affordability of key biologic therapies for millions of patients while contributing to healthcare systems economic sustainability;

Or. en

Amendment 126

Jessica Polfjärd

Motion for a resolution

Recital F a (new)

Motion for a resolutionAmendment
F a. whereas the EU’s scientific leadership must be safeguarded, and the transition from research to market solutions must be strengthened in order for scientific progress to benefit patients;

Or. en

Amendment 127

Ignazio Roberto Marino

Motion for a resolution

Recital F a (new)

Motion for a resolutionAmendment
F a. whereas supporting biotech innovation requires early engaging with regulators, and using scientific evidence in a responsible way, all within a stable and predictable environment;

Or. en

Amendment 128

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Recital F a (new)

Motion for a resolutionAmendment
F a. whereas the industrial dependency of European research on certain inputs that are not produced in Europe, which may hinder its development—such as DNA sequencers;

Or. en

Amendment 129

András Tivadar Kulja

Motion for a resolution

Recital G

Motion for a resolutionAmendment
G. whereas the regulatory framework for biotech-based medicinal products is complex, with multiple laws overlapping, both at national and EU level; whereas the rapid pace of biotech innovation has outpaced current legal frameworks;G. whereas the regulatory framework for biotech-based medicinal products is complex, with multiple legislations overlapping, both at national and EU levels; whereas there is a need for streamline with complementary legislation to ensure that recent, upcoming and ongoing initiatives work efficiently together in the context of biotechnology, including among others the AI ACT, the Pharmaceutical Package, the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR), the Clinical Trials Regulation and the Critical Medicines Act; whereas the rapid pace of biotech innovation has outpaced existing legal frameworks;

Or. en

Amendment 130

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Recital G

Motion for a resolutionAmendment
G. whereas the regulatory framework for biotech-based medicinal products is complex, with multiple laws overlapping, both at national and EU level; whereas the rapid pace of biotech innovation has outpaced current legal frameworks;G. whereas the need to ensure that current and future legislative initiatives are aligned with the whole legislation in the areas of biotechnology, pharmaceuticals, and health in general, and therefore establish mutually synergistic links—including the Pharmaceutical Package, the Medical Devices Regulation (MDR), the In Vitro Diagnostic Medical Devices Regulation (IVDR), the Clinical Trials Regulation, the Orphan Medicinal Products Regulation and the Critical Medicines Regulation, among others;

Or. en

Amendment 131

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Recital G

Motion for a resolutionAmendment
G. whereas the regulatory framework for biotech-based medicinal products is complex, with multiple laws overlapping, both at national and EU level; whereas the rapid pace of biotech innovation has outpaced current legal frameworks;G. whereas the regulatory framework for biotech-based medicinal products is complex, with multiple laws overlapping, both at national and EU level; whereas the rapid pace of biotech innovation has outpaced current legal frameworks; whereas access to financing, the shortage of qualified skills, bottlenecks in the value chain, intellectual property rights, and economic security constitute specific challenges for the European biotechnology and biomanufacturing sector;

Or. en

Amendment 132

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital G

Motion for a resolutionAmendment
G. whereas the regulatory framework for biotech-based medicinal products is complex, with multiple laws overlapping, both at national and EU level; whereas the rapid pace of biotech innovation has outpaced current legal frameworks;G. whereas the regulatory framework for biotech-based medicinal products is complex, with multiple laws overlapping, both at national and EU level; whereas the rapid pace of innovation in biotechnology has created challenges for existing regulatory systems, making the development of clear, coherent regulatory pathways essential to support innovation and ensure patient safety;

Or. en

Amendment 133

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Recital G

Motion for a resolutionAmendment
G. whereas the regulatory framework for biotech-based medicinal products is complex, with multiple laws overlapping, both at national and EU level; whereas the rapid pace of biotech innovation has outpaced current legal frameworks;G. whereas the regulatory framework for biotech-based medicinal products is complex, with multiple laws overlapping, both at national and EU level; whereas the rapid pace of biotech innovation has outpaced current legal frameworks; especially in areas like gene editing (e.g., CRISPR), mRNA, synthetic biology, or advanced therapeutics;

Or. en

Amendment 134

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Recital G a (new)

Motion for a resolutionAmendment
G a. whereas an effective regulatory framework for conducting clinical trials is essential to the competitiveness of the most innovation-intensive aspects of the EU’s pharmaceuticals and biotechnology sector; whereas the divergence in standards applied by National Competent Authorities across Member States slows down the assessment of applications for multi-country trial approvals, making the process more costly and burdensome;

Or. en

Amendment 135

Ignazio Roberto Marino

Motion for a resolution

Recital G a (new)

Motion for a resolutionAmendment
G a. whereas an effective regulatory framework for clinical trials is crucial to maintaining the EU’s competitiveness in the most innovation-driven areas of the pharmaceutical and biotechnology sectors; whereas differences in the standards used by National Competent Authorities and Ethics Committees across Member States delay the evaluation of multi-country trial applications, increasing both costs and administrative burdens;

Or. en

Amendment 136

Jessica Polfjärd

Motion for a resolution

Recital G a (new)

Motion for a resolutionAmendment
G a. whereas a clear, coherent and efficient regulatory framework is essential to bolster the biotechnology sector in the EU;

Or. en

Amendment 137

Jessica Polfjärd

Motion for a resolution

Recital G b (new)

Motion for a resolutionAmendment
G b. whereas divergent national standards can be costly and burdensome, especially for innovation-intensive sectors; whereas such divergent national standards can create obstacles for innovation, particularly in regards to multi-country clinical trials;

Or. en

Amendment 138

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Recital H

Motion for a resolutionAmendment
H. whereas small and medium-sized enterprises (SMEs) represent over 99 % of EU businesses6 and constitute the majority in the biotechnology field;H. whereas small and medium-sized enterprises (SMEs) constitute a significant part of the industrial fabric dedicated to biotechnology, and recognizing the importance of supporting growth environments and business-university programs that enable companies in this sector to gather knowledge of basic research and to achieve both financial independence and sufficient economies of scale to be competitive in the international market;
6 Lincoln, A., ‘SMEs in Europe’s bioeconomy and agri-food landscape’, Europa Bio, 10 January 2025.

Or. en

Amendment 139

Billy Kelleher

Motion for a resolution

Recital H

Motion for a resolutionAmendment
H. whereas small and medium-sized enterprises (SMEs) represent over 99 % of EU businesses6 and constitute the majority in the biotechnology field;H. whereas small and medium-sized enterprises (SMEs) aand small mid-caps (SMCs) represent over 99 % of EU businesses6 and constitute the majority in the biotechnology field; whereas the European Commission should adopt a specific definition of biopharmaceutical SMCs, reflecting the reality of the sector;
6 Lincoln, A., ‘SMEs in Europe’s bioeconomy and agri-food landscape’, Europa Bio, 10 January 2025.6 Lincoln, A., ‘SMEs in Europe’s bioeconomy and agri-food landscape’, Europa Bio, 10 January 2025.

Or. en

Amendment 140

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital H

Motion for a resolutionAmendment
H. whereas small and medium-sized enterprises (SMEs) represent over 99 % of EU businesses6 and constitute the majority in the biotechnology field;H. whereas small and medium-sized enterprises (SMEs) represent over 99% of EU businesses and play a key role in the biotechnology sector, particularly in driving early-stage innovation, advancing emerging technologies, and contributing to medicines discovery and development;
6 Lincoln, A., ‘SMEs in Europe’s bioeconomy and agri-food landscape’, Europa Bio, 10 January 2025.

Or. en

Amendment 141

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Recital H

Motion for a resolutionAmendment
H. whereas small and medium-sized enterprises (SMEs) represent over 99 % of EU businesses6 and constitute the majority in the biotechnology field;H. whereas small and medium-sized enterprises (SMEs) represent over 99 % of EU businesses6 and constitute the majority in the biotechnology field; whereas EU biotech SMEs face their own specific challenges, hindering innovation and growth;
6 Lincoln, A., ‘SMEs in Europe’s bioeconomy and agri-food landscape’, Europa Bio, 10 January 2025.6 Lincoln, A., ‘SMEs in Europe’s bioeconomy and agri-food landscape’, Europa Bio, 10 January 2025.

Or. en

Amendment 142

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Recital H a (new)

Motion for a resolutionAmendment
H a. whereas, sustainable global supply chains are critical component to resilience and open strategic autonomy, particularly for medicinal products and devices. Trade barriers should be addressed to ensure a level playing field for innovation, while tariffs on inputs and equipment should be avoided given their cumulative negative effect throughout the supply chain, driving up the cost of products and reducing competitiveness of European industry;

Or. en

Amendment 143

Elena Nevado del Campo, Dolors Montserrat

Motion for a resolution

Recital H a (new)

Motion for a resolutionAmendment
H a. whereas close cooperation between the pharmaceutical sector, patient associations, and public health bodies plays a crucial role in advancing and applying biotechnological and life science innovations that meet patient needs and contribute to better health outcomes; highlights the need to strengthen public-private partnerships that support scientific research and facilitate fair and timely access to novel therapies;

Or. en

Amendment 144

Ignazio Roberto Marino

Motion for a resolution

Recital H a (new)

Motion for a resolutionAmendment
H a. whereas effective global supply chains are essential for resilience, especially for products like critical medicines; whereas trade barriers should be tackled to ensure fair conditions for innovation, and tariffs on inputs and equipment should be avoided, as they increase overall supply chain costs and reduce competitiveness;

Or. en

Amendment 145

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital I

Motion for a resolutionAmendment
I. whereas one of STEP’s target investment areas is biotechnology; whereas, according to the EU Competitiveness Compass, a strategy for European life science will be presented in 2025 and an EU Biotech Act in 2026;I. whereas one of STEP’s target investment areas is biotechnology; whereas, according to the EU Competitiveness Compass, a strategy for European life science will be presented in 2025 and an EU Biotech Act in 2026; whereas ensuring coherence and synergies between EU initiatives and legislative frameworks is essential to improve regulatory clarity and create a more innovation-friendly environment;

Or. en

Amendment 146

Elena Nevado del Campo, Dolors Montserrat

Motion for a resolution

Recital I

Motion for a resolutionAmendment
I. whereas one of STEP’s target investment areas is biotechnology; whereas, according to the EU Competitiveness Compass, a strategy for European life science will be presented in 2025 and an EU Biotech Act in 2026;I. whereas one of STEP’s target investment areas is biotechnology; whereas, according to the EU Competitiveness Compass, a strategy for European life science will be presented by the European Commission in 2025 and an EU Biotech Act in 2026; whereas the European Commission only commissioned its preparatory study in early 2025;

Or. en

Amendment 147

Billy Kelleher

Motion for a resolution

Recital I a (new)

Motion for a resolutionAmendment
I a. whereas any initiatives under the EU Biotech Act must be coherent, aligning healthcare and industrial policy, as well as other horizontal areas at EU and Member States level; whereas it is essential to ensure that such initiatives are subject to continuous assessment to determine when existing legislation may no longer be appropriate or fit for purpose; whereas due consideration should be given to the cumulative impact of overlapping or conflicting legislative provisions at both EU and national levels;

Or. en

Amendment 148

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Recital I a (new)

Motion for a resolutionAmendment
I a. whereas the recent trends of international trade and the impact on European research projects and universities of the budget cuts and policy shifts in the United States regarding research, higher education, and academic management, must be adressed;

Or. en

Amendment 149

Aurelijus Veryga

Motion for a resolution

Recital I a (new)

Motion for a resolutionAmendment
I a. whereas the lack of harmonisation and streamlining of standards across Member States creates regulatory divergence, slows down the assessment of multi-country clinical study applications, and increases costs and administrative burdens;

Or. en

Amendment 150

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital I a (new)

Motion for a resolutionAmendment
I a. whereas ensuring a stable and autonomous supply of critical raw materials and feedstock is essential for the EU’s strategic sovereignty, economic resilience, and leadership in biotechnology;

Or. en

Amendment 151

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Recital I b (new)

Motion for a resolutionAmendment
I b. whereas Europe needs to leverage the strength of its single market and its ability to mobilize capital for investment in biotechnology, in line with the observations made in the Draghi, Heitor and Letta reports;

Or. en

Amendment 152

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Recital I c (new)

Motion for a resolutionAmendment
I c. whereas security policy in the European Union should address and fund health security issues and investment in healthcare as part of the security strategy, as highlighted by the Niinistö report;

Or. en

Amendment 153

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin

Motion for a resolution

Recital J

Motion for a resolutionAmendment
J. whereas biotechnologies offer an important opportunity for the EU, but also carry significant challenges and risks that must be carefully considered, such as those related to ethical and security concerns;J. whereas the biotechnology regulation must take into account crisis preparedness and the Union's strategic autonomy, both from the perspective of security, public health, and the ability to respond to health threats—such as those addressed by Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health, repealing Decision No. 1082/2013/EU, or the Regulation on Compulsory Licensing for Crisis Management agreed upon by the co-legislators on 21 May 2025;

Or. en

Amendment 154

Elena Nevado del Campo, Dolors Montserrat

Motion for a resolution

Recital J

Motion for a resolutionAmendment
J. whereas biotechnologies offer an important opportunity for the EU, but also carry significant challenges and risks that must be carefully considered, such as those related to ethical and security concerns;J. whereas biotechnologies offer an important opportunity for the EU, but also carry significant challenges and risks that must be carefully considered, such as those related to ethical and security concerns; whereas ethics should be informed by scientific progress to ensure that regulations and policies reflect current knowledge and promote societal well-being; underlines the need for continuous dialogue between scientists, and policymakers to adapt ethical frameworks to technological and scientific developments;

Or. en

Amendment 155

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Recital J

Motion for a resolutionAmendment
J. whereas biotechnologies offer an important opportunity for the EU, but also carry significant challenges and risks that must be carefully considered, such as those related to ethical and security concerns;J. whereas biotechnologies offer an important opportunity for the EU to enhance its scientific leadership and competitiveness; whereas it raises ethical and security considerations that must be addressed through clear, science-based and transparent governance frameworks;

Or. en

Amendment 156

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou

Motion for a resolution

Recital J a (new)

Motion for a resolutionAmendment
J a. whereas, in light of rising antimicrobial resistance, the EU Biotech Act should acknowledge the significance of innovative biological therapies such as bacteriophages in advancing the Union’s One Health goals, enhancing health system resilience, and fostering sustainable and targeted biocontrol strategies; whereas in July 2022, the Commission, together with the Member States, identified antimicrobial resistance (AMR) as one of the top three priority health threats in the EU1a;
1a (1) https://health.ec.europa.eu/publications/hera-factsheet-health-union-identifying-top-3-priority-health-threats_en.

Or. en

Amendment 157

Elena Nevado del Campo, Dolors Montserrat

Motion for a resolution

Recital J a (new)

Motion for a resolutionAmendment
J a. whereas biotechnology is one of the EU’s fastest-growing and most innovative sectors, contributing significantly to economic growth and job creation; whereas in 2018 alone, the sector directly generated €31 billion in GDP and provided over 210,000 direct jobs across healthcare and other sectors, while supporting more than 625,000 additional jobs indirectly1a;
1a European Parliament, EPRS, New European biotech act Which way forward?, May 2025

Or. en

Amendment 158

Dan-Ştefan Motreanu

Motion for a resolution

Recital J a (new)

Motion for a resolutionAmendment
J a. Recalls that regulatory and health technology assessment (HTA) sandboxes represent effective tools to future-proof healthcare systems by providing controlled environments for testing and refining innovative solutions, ensuring the safe and effective integration of new technologies and methodologies into healthcare;

Or. en

Amendment 159

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Recital J a (new)

Motion for a resolutionAmendment
J a. whereas, in the context of increasing antimicrobial resistance (AMR), the EU Biotech Act should recognize the role of innovative biological therapies, such as bacteriophages, in supporting the Union’s One Health objectives, strengthening health resilience, and promoting sustainable and targeted biocontrol;

Or. en

Amendment 160

Ignazio Roberto Marino

Motion for a resolution

Recital J a (new)

Motion for a resolutionAmendment
J a. whereas it is important to assess the wider public health implications of biotechnology beyond medical uses, including its application in agriculture, environmental interventions, and industrial processes;

Or. en

Amendment 161

András Tivadar Kulja

Motion for a resolution

Recital J a (new)

Motion for a resolutionAmendment
J a. whereas it is crucial that EU continues to stay competitive globally in attracting and promoting investment and innovation in biotech and biomanifacturing;

Or. en

Amendment 162

Aurelijus Veryga

Motion for a resolution

Recital J a (new)

Motion for a resolutionAmendment
J a. whereas the EU’s share in global clinical trials has declined from 22 % in 2013 to 12 % in 2023;

Or. en

Amendment 163

Ignazio Roberto Marino

Motion for a resolution

Recital J b (new)

Motion for a resolutionAmendment
J b. whereas recent data show that Europe is losing ground in global clinical trials compared to China and the United States, with the EU’s share of commercial trials falling from 22% in 2013 to 12% in 2023, meaning 60,000 fewer patients have access to a trial involving a country within the EEA; whereas inconsistent regulatory requirements between Member States make it harder to submit multi-country clinical trial applications;

Or. en

Amendment 164

Elena Nevado del Campo, Dolors Montserrat

Motion for a resolution

Recital J b (new)

Motion for a resolutionAmendment
J b. whereas biotechnology accounts for approximately 5% of all patents filed in the EU between 2001 and 2020, reflecting its role as a key driver of innovation; whereas the overwhelming majority of these patents—over 96%—are linked to industrial and medical applications1b;
1b European Commission, Joint Research Centre, Exploring the global landscape of biotech Innovation: preliminary insights from patent analysis, 2024

Or. en

Amendment 165

Ignazio Roberto Marino

Motion for a resolution

Recital J c (new)

Motion for a resolutionAmendment
J c. whereas recent data show that Europe is losing ground in global clinical trials compared to China and the United States, with the EU’s share of commercial trials falling from 22% in 2013 to 12% in 2023; whereas inconsistent regulatory requirements between Member States make it harder to submit multi-country clinical trial applications;

Or. en

Amendment 166

Ignazio Roberto Marino

Motion for a resolution

Recital J d (new)

Motion for a resolutionAmendment
J d. whereas the Accelerating Clinical Trials in the EU (ACT EU) initiative, launched in 2022 by the European Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA), aims to improve the way clinical trials are started, designed, and conducted, in order to support the development of safe, effective, and high-quality medicines and to better integrate clinical research into national health systems;

Or. en

Amendment 167

Billy Kelleher

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, are transforming care and targeting previously untreatable diseases;1. Highlights that biotechnologies and therapies, such as CAR-T, mRNA, CRISPR and ATMPs, are transforming care and targeting previously untreatable diseases; including rare diseases; underlines that such biotechnologies require legislations and guidelines that respect the unique characteristics of these technologies, including ATMPs and rare disease treatments;

Or. en

Amendment 168

Aurelijus Veryga

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, are transforming care and targeting previously untreatable diseases;1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, are transforming care and targeting previously untreatable diseases, including rare diseases; underlines that such biotechnologies require legislations and guidelines that respect the unique characteristics of these technologies, including ATMPs and rare disease treatments;

Or. en

Amendment 169

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, are transforming care and targeting previously untreatable diseases;1. Highlights that biotechnology therapies, such as ATMPs, monoclonal antibodies, mRNA therapeutics, CRISPR, RNA interference therapies, and personalised medicine, are transforming care and targeting previously untreatable diseases;

Or. en

Amendment 170

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, are transforming care and targeting previously untreatable diseases;1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, when properly assessed and regulated, have the potential to contribute to health care and target previously untreatable diseases;

Or. en

Amendment 171

Michalis Hadjipantela

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, are transforming care and targeting previously untreatable diseases;1. Highlights that biotechnologies and therapies, such as CAR-T, mRNA, CRISPR, T-cell engagers (TCE) and ATMPs, are transforming care and targeting previously untreatable diseases, including rare diseases;

Or. en

Amendment 172

András Tivadar Kulja

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, are transforming care and targeting previously untreatable diseases;1. Highlights that biotechnologies and therapies, such as CAR-T, mRNA, CRISPR, T-cell engagers (TCE) and ATMPs, are transforming care and targeting previously untreatable diseases, including rare diseases;

Or. en

Amendment 173

Ignazio Roberto Marino

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, are transforming care and targeting previously untreatable diseases;1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs and preventive medicine are transforming care and prevention targeting previously untreatable diseases;

Or. en

Amendment 174

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, are transforming care and targeting previously untreatable diseases;1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, but also small molecules, are transforming care and targeting previously untreatable diseases;

Or. en

Amendment 175

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and ATMPs, are transforming care and targeting previously untreatable diseases;1. Highlights that biotechnology therapies, such as CAR-T, mRNA, CRISPR and other ATMPs, are transforming care and targeting previously untreatable diseases;

Or. en

Amendment 176

Ruggero Razza

Motion for a resolution

Paragraph 1 a (new)

Motion for a resolutionAmendment
1a. Stresses that during the COVID-19 pandemic, biotechnology played a key role in the swift development of innovative vaccines, including mRNA vaccines and advanced molecular diagnostic tools; biotechnology proved the need for long-term strategic investment in biotechnological research;

Or. it

Amendment 177

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 1 a (new)

Motion for a resolutionAmendment
1 a. Welcomes innovative, human-centered non-animal methodologies (NAMs), including organoids, organ-on-chips, patient-derived cell models, multi-omics technologies, and AI-driven in silico tools that can help improve disease understanding, accelerate drug discovery, and reduce failure rates in clinical trials;

Or. en

Amendment 178

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Paragraph 1 a (new)

Motion for a resolutionAmendment
1 a. Stresses that new applications of biotechnology, such as phagic therapies, can provide solutions for microbial resistance, which is directly responsible for the deaths of more than 1 million people globally each year and for increased costs for health systems and society;

Or. en

Amendment 179

Jessica Polfjärd

Motion for a resolution

Paragraph 1 a (new)

Motion for a resolutionAmendment
1 a. Stresses that Europe’s competitiveness in life sciences must encompass a strong patient perspective, ensuring that research and innovation translate into timely access to effective treatments and medicines across the EU;

Or. en

Amendment 180

Aurelijus Veryga

Motion for a resolution

Paragraph 1 a (new)

Motion for a resolutionAmendment
1 a. Highlights the strategic importance for the EU of fostering a strong health biotechnology ecosystem to support research and development, manufacturing, and equitable patient access to innovative medicines;

Or. en

Amendment 181

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 1 b (new)

Motion for a resolutionAmendment
1 b. Encourages the development and validation of fit for purpose new approach methodologies (NAMs) for the safety assessment of emerging biotechnologies;

Or. en

Amendment 182

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 2

Motion for a resolutionAmendment
2. Emphasises that biotechnology therapies have a growing impact on diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders;2. Emphasises that biotechnology therapies, including off-patent biologic medicines (biosimilar medicines), have a growing impact on diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders; and that biosimilar medicines will significantly contribute to the economic sustainability of healthcare systems and in delivering equitable and timely access for patients;

Or. en

Amendment 183

Adam Jarubas

Motion for a resolution

Paragraph 2

Motion for a resolutionAmendment
2. Emphasises that biotechnology therapies have a growing impact on diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders;2. Emphasises that biotechnology therapies have a growing impact on diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders, in parallel it is important to underline the value of off-patent biologic medicine (biosimilar medicines) to foster equitable and timely access to medicines and in making healthcare systems sustainable;

Or. en

Amendment 184

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 2

Motion for a resolutionAmendment
2. Emphasises that biotechnology therapies have a growing impact on diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders;2. Emphasises that biotechnology therapies have a growing impact on diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders, and can contribute to addressing global health challenges such as antimicrobial resistance;

Or. en

Amendment 185

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 2

Motion for a resolutionAmendment
2. Emphasises that biotechnology therapies have a growing impact on diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders;2. Emphasises that biotechnology therapies have a growing impact on diseases such as cancer, cardiovascular conditions, rare diseases and paediatric cancers, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders and are also key to innovating much-needed novel antimicrobials;

Or. en

Amendment 186

Ignazio Roberto Marino

Motion for a resolution

Paragraph 2

Motion for a resolutionAmendment
2. Emphasises that biotechnology therapies have a growing impact on diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders;2. Emphasises that biotechnology preventive medicine and therapies have a growing impact on treating and preventing diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders;

Or. en

Amendment 187

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 2

Motion for a resolutionAmendment
2. Emphasises that biotechnology therapies have a growing impact on diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders;2. Emphasises that human-centered biotechnology therapies have a growing impact on diseases such as cancer, cardiovascular conditions, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases, and metabolic disorders;

Or. en

Amendment 188

Ignazio Roberto Marino

Motion for a resolution

Paragraph 2 a (new)

Motion for a resolutionAmendment
2 a. Stresses that innovations in biotechnology and life sciences are essential for the prevention, diagnosis, and treatment of high-burden diseases such as cancer, diabetes, cardiovascular, and neurodegenerative conditions; emphasises the need to ensure equitable access to these therapies across all Member States;

Or. en

Amendment 189

Aurelijus Veryga

Motion for a resolution

Paragraph 2 a (new)

Motion for a resolutionAmendment
2 a. Calls for a common clinical trials framework that enables the appropriate use of real-world evidence in the assessment of biotechnology therapies; requests the Commission to present the current state of play in this area, along with recommendations for potential improvements;

Or. en

Amendment 190

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou

Motion for a resolution

Paragraph 2 a (new)

Motion for a resolutionAmendment
2 a. Underlines the role biosimilar medicines will play in enhancing the sustainability of healthcare systems and ensuring equitable and timely access to treatment for patients;

Or. en

Amendment 191

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 3

Motion for a resolutionAmendment
3. Stresses the potential of biotechnology in enhancing research into genetic conditions such as Down syndrome and enabling early diagnosis, innovative treatments, better prognosis, trial stratification and long-term monitoring;3. Acknowledges that advances in biotechnology, particularly in the fields of medically assisted reproduction and genetic testing for therapeutic and preventive purposes, represent a major opportunity to strengthen individual freedoms, improve reproductive health outcomes and support responses to fertility challenges in Europe, including the demographic decline in some Member States ; recalls, in line with its resolution of 24 June 2021 on the situation regarding sexual and reproductive health and rights in the European Union, the importance of ensuring equal access to medically assisted reproduction for all persons, regardless of gender identity, sexual orientation, marital or socio-economic status; underlines the need for inclusive, rights-based and non-discriminatory policies in this field; encourages the development and transparent oversight of genetic innovations for therapeutic purposes, notably as a tool to help prevent the transmission of serious, debilitating or life-threatening hereditary conditions, in full respect of autonomy, informed consent and fundamental rights;

Or. en

Amendment 192

András Tivadar Kulja

Motion for a resolution

Paragraph 3

Motion for a resolutionAmendment
3. Stresses the potential of biotechnology in enhancing research into genetic conditions such as Down syndrome and enabling early diagnosis, innovative treatments, better prognosis, trial stratification and long-term monitoring;3. Stresses the potential of biotechnology in enhancing research into genetic conditions, understanding and developing therapeutics for rare diseases, genetic diseases, and neurological and neurodegenerative diseases; highlights the potential of enabling early diagnosis, innovative treatments, better prognosis, trial stratification and long-term monitoring;

Or. en

Amendment 193

Ignazio Roberto Marino

Motion for a resolution

Paragraph 3

Motion for a resolutionAmendment
3. Stresses the potential of biotechnology in enhancing research into genetic conditions such as Down syndrome and enabling early diagnosis, innovative treatments, better prognosis, trial stratification and long-term monitoring;3. Stresses the potential of biotechnology in enhancing research into genetic conditions such as Down syndrome and enabling effective prevention, early diagnosis, innovative treatments, better prognosis, trial stratification and long-term monitoring;

Or. en

Amendment 194

Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 3

Motion for a resolutionAmendment
3. Stresses the potential of biotechnology in enhancing research into genetic conditions such as Down syndrome and enabling early diagnosis, innovative treatments, better prognosis, trial stratification and long-term monitoring;3. Stresses the potential of human-centered biotechnology in enhancing research into genetic conditions such as Down syndrome and enabling early diagnosis, innovative treatments, better prognosis, trial stratification and long-term monitoring;

Or. en

Amendment 195

Jessica Polfjärd

Motion for a resolution

Paragraph 3

Motion for a resolutionAmendment
3. Stresses the potential of biotechnology in enhancing research into genetic conditions such as Down syndrome and enabling early diagnosis, innovative treatments, better prognosis, trial stratification and long-term monitoring;3. Stresses the potential of biotechnology in enhancing research into genetic conditions and enabling early diagnosis, innovative treatments, better prognosis, trial stratification and long-term monitoring;

Or. en

Amendment 196

Billy Kelleher

Motion for a resolution

Paragraph 3

Motion for a resolutionAmendment
3. Stresses the potential of biotechnology in enhancing research into genetic conditions such as Down syndrome and enabling early diagnosis, innovative treatments, better prognosis, trial stratification and long-term monitoring;3. Stresses the potential of biotechnology in enhancing research into genetic conditions and enabling early diagnosis, innovative treatments, better prognosis, trial stratification and long-term monitoring;

Or. en

Amendment 197

Aurelijus Veryga

Motion for a resolution

Paragraph 3 a (new)

Motion for a resolutionAmendment
3 a. Underlines the need to scale up genomic sequencing capacity to support early diagnosis and screening, thereby enabling better healthcare delivery; calls for adequate funding and improved coordination of national genetic testing programmes, including the adoption of EU guidelines to harmonise newborn screening and other genetic initiatives across Member States;

Or. en

Amendment 198

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Paragraph 3 a (new)

Motion for a resolutionAmendment
3 a. Stresses the importance of a holistic development of knowledge within the life sciences, with full respect for academic freedom, ensuring systematic attention to the gender dimension and other relevant vulnerability factors throughout the research process;

Or. en

Amendment 199

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Paragraph 3 b (new)

Motion for a resolutionAmendment
3 b. Stresses the importance of enhanced cooperation and knowledge exchange at the European level to address shared health challenges, such as cancer, through biotechnological applications; underlines the need for a gender-sensitive approach in the clinical application of biotech solutions, taking into account biological differences in cancer risk, diagnosis, and treatment;

Or. en

Amendment 200

Ignazio Roberto Marino

Motion for a resolution

Paragraph 4

Motion for a resolutionAmendment
4. Underlines the role of biotechnology innovation, such as lab-grown tissues, in advancing regenerative medicine and drug testing;4. Underlines the role of biotechnology innovation, such as lab-grown tissues, in advancing regenerative medicine and drug testing; recognises that biotechnology can play a major role in reducing and replacing animal testing by using advanced tools such as organ-on-a-chip, organoids, 3D bioprinting, and in vitro human cell models; underlines the contribution of AI technologies in generating human-relevant data for research and safety assessments; calls for increased investment, regulatory approval, and broader use of these alternatives in EU research and risk assessment systems;

Or. en

Amendment 201

Adam Jarubas

Motion for a resolution

Paragraph 4

Motion for a resolutionAmendment
4. Underlines the role of biotechnology innovation, such as lab-grown tissues, in advancing regenerative medicine and drug testing;4. Underlines the role of biotechnology innovation, such as lab-grown tissues, in advancing regenerative medicine and drug testing and the importance of continuous innovation in biomanufacturing processes throughout the technology life-span, including from off-patent medicines actors;

Or. en

Amendment 202

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 4

Motion for a resolutionAmendment
4. Underlines the role of biotechnology innovation, such as lab-grown tissues, in advancing regenerative medicine and drug testing;4. Underlines the role of biotechnology innovation, such as lab-grown tissues, in advancing regenerative medicine and drug testing; highlights how synthetic and generative biology enable next-gen therapies, smart tissue interfaces, and organ-on-chip systems;

Or. en

Amendment 203

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 4

Motion for a resolutionAmendment
4. Underlines the role of biotechnology innovation, such as lab-grown tissues, in advancing regenerative medicine and drug testing;4. Emphasizes the role of biotechnological innovation—such as laboratory-grown tissues or the use of stem cells—in promoting regenerative medicine, disease modeling, and drug testing through procedures like the "organ-on-a-chip";

Or. en

Amendment 204

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 4

Motion for a resolutionAmendment
4. Underlines the role of biotechnology innovation, such as lab-grown tissues, in advancing regenerative medicine and drug testing;4. Underlines the role of biotechnology innovation, such as lab-grown tissues, including patient-derived organoids and organ-on-chip technologies, in advancing regenerative medicine and drug testing;

Or. en

Amendment 205

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Paragraph 4

Motion for a resolutionAmendment
4. Underlines the role of biotechnology innovation, such as lab-grown tissues, in advancing regenerative medicine and drug testing;4. Underlines the role of biotechnology innovation, such as biomaterials and lab-grown tissues, in advancing regenerative medicine and drug testing;

Or. en

Amendment 206

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Paragraph 4 a (new)

Motion for a resolutionAmendment
4 a. Stresses the importance of blue biotechnology (marine biotechnology) for the development of health applications, for example in the discovery and development of new medicines with antimicrobial properties, treatments modulating the immune and anti-inflammatory response, new materials for tissue regeneration, cosmetic and dermatological applications, or identification of enzymes and biosensors for use in medical diagnostic systems;

Or. en

Amendment 207

Viktória Ferenc, Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 4 a (new)

Motion for a resolutionAmendment
4 a. Underlines that organ-on-chip is being primarily applied for the development of new medicines, however, it is also growing in importance for safety testing of chemicals used in consumer goods such as cosmetics, while in biomedical research, organ-on-chip devices have the potential to reduce and replace animal experiments;

Or. en

Amendment 208

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 5

Motion for a resolutionAmendment
5. Recalls that molecular diagnostics using genomic and proteomic biomarkers are key for early detection and personalised treatment of major diseases;5. Recalls that molecular diagnostics using genomic and proteomic biomarkers are essential for the early detection and personalized treatment of serious diseases, and, where appropriate, enable the implementation of public policies for population-wide disease screening, whether selective or general depending on the case;

Or. en

Amendment 209

Margarita de la Pisa Carrión, Viktória Ferenc

Motion for a resolution

Paragraph 5

Motion for a resolutionAmendment
5. Recalls that molecular diagnostics using genomic and proteomic biomarkers are key for early detection and personalised treatment of major diseases;5. Recalls that molecular diagnostics using genomic and proteomic biomarkers are key for early detection and personalised treatment of major diseases; highlights the value of integrative omics and long-read sequencing in advancing precision medicine;

Or. en

Amendment 210

Radan Kanev

Motion for a resolution

Paragraph 5

Motion for a resolutionAmendment
5. Recalls that molecular diagnostics using genomic and proteomic biomarkers are key for early detection and personalised treatment of major diseases;5. Recalls that molecular diagnostics using genomic, epigenomic and proteomic biomarkers are key for early detection and personalised treatment of major diseases;

Or. en

Amendment 211

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 5 a (new)

Motion for a resolutionAmendment
5a. Stresses the role played by health-care professionals such as pharmacists as experts in medication throughout the different stages of a product's life cycle, from primary research to post-marketing.

Or. es

Amendment 212

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 5 b (new)

Motion for a resolutionAmendment
5b. Underscores the need to facilitate the reception, preparation, storage and dispensing of biotechnological medicines in hospitals, within a clear and efficient management framework; stresses the importance of setting up competent multidisciplinary teams, including hospital pharmacy teams, with appropriately designed spaces, to ensure patients receive safe, high-quality and uninterrupted access to this type of treatment;

Or. es

Amendment 213

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 5 c (new)

Motion for a resolutionAmendment
5c. Highlights the importance for hospital pharmacy services to have adequate equipment for the storage and management of this type of medicine, as well as the need to simplify the procedures linked to the receipt of CAR-T medicines, among others:

Or. es

Amendment 214

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 6

Motion for a resolutionAmendment
6. Stresses that functional epigenomics and integrative multi-omics represent a crucial advancement in biomedical research and can significantly help guide clinical action;6. Stresses that functional epigenomics and integrative multi-omics represent a crucial advancement in biomedical research and can significantly help guide clinical action by uncovering precise molecular mechanisms;

Or. en

Amendment 215

Ignazio Roberto Marino

Motion for a resolution

Paragraph 6 a (new)

Motion for a resolutionAmendment
6 a. Highlights that bacteriophage therapy is a leading example of innovative biotechnology with the potential to tackle the growing challenge of antimicrobial resistance (AMR); stresses that this targeted approach offers a promising alternative or complement to traditional antibiotics; notes with concern that, despite its potential, the field receives little commercial interest and limited funding; therefore calls for increased public investment in research and development of phage therapy and similar biotechnological solutions to AMR;

Or. en

Amendment 216

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 6 a (new)

Motion for a resolutionAmendment
6 a. Recognises the role of in silico medicine, such as the European Commission Virtual Human Twins initiative, in enabling cost-effective, scalable, and ethical innovation for biomedical research, personalised therapies, and regulatory decision-making;

Or. en

Amendment 217

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 6 a (new)

Motion for a resolutionAmendment
6 a. Urges the application of the One Health approach in biotechnology R&D, promoting more sustainable development of new medicines and vaccines, as well as better management of emerging and re-emerging diseases;

Or. en

Amendment 218

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 6 a (new)

Motion for a resolutionAmendment
6 a. Highlights the potential of biotechnologically engineered animal models, like transgenic mice and CRISPR-edited animals, to study genetic disorders and accelerate targeted treatment development;

Or. en

Amendment 219

Aurelijus Veryga

Motion for a resolution

Paragraph 6 a (new)

Motion for a resolutionAmendment
6 a. Calls for the application of the One Health approach in biotechnology, promoting more sustainable development of new medicines and vaccines;

Or. en

Amendment 220

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 6 a (new)

Motion for a resolutionAmendment
6 a. Emphasizes the importance of genetic surveillance of pathogens and the rapid design of vaccines in epidemiological control and public health;

Or. en

Amendment 221

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 6 b (new)

Motion for a resolutionAmendment
6 b. Highlights the potential for integrating these techniques into the healthcare systems of the Member States to enhance the efficiency of primary and hospital care, contributing to more effective service delivery and the deployment of new opportunities in preventive medicine;

Or. en

Amendment 222

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 6 b (new)

Motion for a resolutionAmendment
6 b. Underlines that biotechnology innovations influences biosecurity of human population in the era of new viral and microbial hazardous agents responsible for high mortality rate and therefore being significant biohazardous factors;

Or. en

Amendment 223

Ignazio Roberto Marino

Motion for a resolution

Paragraph 6 b (new)

Motion for a resolutionAmendment
6 b. Stresses the importance of biotechnology research and development in addressing unmet medical needs, such as treatments for rare and paediatric diseases; calls for public funding to be directed towards these priorities;

Or. en

Amendment 224

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 6 b (new)

Motion for a resolutionAmendment
6 b. Emphasises biotechnology’s growing role in forensics, enhancing autopsy precision through techniques like toxicogenomics and microbiome analysis;

Or. en

Amendment 225

Aurelijus Veryga

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;7. Calls for the EU Biotech Act to optimise the current regulatory framework and ensure it reflects the reality and specificities of different biotechnology therapies, such as ATMPs, in order to support innovation while ensuring high security standards; calls on the European Commission to pursue international regulatory convergence, including through mutual recognition agreements with trusted partners and enhanced collaboration with international regulatory bodies;

Or. en

Amendment 226

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;7. Calls for the EU Biotech Act to review the current regulatory framework, ensuring it remains robust and aligned with the latest scientific advancements and the evolving regulatory landscape, while maintaining high standards of safety, quality, and efficacy, and also renewing and adapting it to foster innovation, improve access to treatments, and fully support the development and uptake of off-patent medicines;

Or. en

Amendment 227

Adam Jarubas

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation, including the second-wave of off-patent- led innovation, while ensuring high security standards and the removal of regulatory burden through process streamlining based on experience and scientific evidence;

Or. en

Amendment 228

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;7. Calls for the EU Biotech Act to strengthen the current regulatory framework in order to ensure high security, environmental, animal welfare, ethical and privacy standards and to accelerate acceptance of innovative human-centered technologies, in line with the One Health approach;

Or. en

Amendment 229

Laurent Castillo

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards, taking into account its interaction with existing legislative texts or those that are under discussion;

Or. fr

Amendment 230

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high safety standards; encourages to consider international best practices to support regulatory streamlining and maintain global competitiveness;

Or. en

Amendment 231

András Tivadar Kulja

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;7. Calls for the EU Biotech Act to optimise the current regulatory framework and take into account the specificities and unique characteristics of different biotechnologies, such as OMPs and ATMPs, in order to support innovation while ensuring high security standards;

Or. en

Amendment 232

Ignazio Roberto Marino

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;7. Calls for the EU Biotech Act to take into account the current regulatory framework of biotechnology in healthcare in order to support innovation while ensuring high safety standards, as well as public health and environmental protection;

Or. en

Amendment 233

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation, including the off-patent led one, while ensuring high safety standards and compliance with the ethical framework;

Or. en

Amendment 234

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;7. Calls for the EU regulation on biotechnology to simplify the current regulatory framework in order to support innovation while ensuring therapies and diagnostics with high standards of safety, quality and effectiveness;

Or. en

Amendment 235

Jessica Polfjärd

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;7. Calls for the EU Biotech Act to address the regulatory framework contributing to a simpler, clearer and more effective regulatory environment for the biotechnology sector, boosting innovation in the EU;

Or. en

Amendment 236

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high security standards;7. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high patient safety and security standards;

Or. en

Amendment 237

Billy Kelleher

Motion for a resolution

Paragraph 7 a (new)

Motion for a resolutionAmendment
7 a. Calls for a harmonised and streamlined clinical trials framework to promote increased efficiency and transparency in approval processes across Member States, reducing administrative delays and fostering cross-border collaboration and alignment; calls on the Commission to reduce timelines for approvals of clinical trials to 30 days from currently over 100 days, with a riskbased assessment; calls for increased coordination for innovative biotechnologies that require the use of In Vitro Diagnostics (IVDs) and Medical Devices (MDs) through unified processes for submissions and assessments of clinical trials involving drug-device combination products; calls on the Commission to assess the current situation and hurdles, as well as to implement improvements to the Clinical Trials IT system and a targeted revision of the Clinical Trials Regulation;

Or. en

Amendment 238

Elena Nevado del Campo, Dolors Montserrat

Motion for a resolution

Paragraph 7 a (new)

Motion for a resolutionAmendment
7 a. Highlights that the forthcoming EU Biotech Act should be closely aligned with the ongoing revision of the Pharmaceutical Legislation and the proposed Critical Medicines Act, in order to ensure policy coherence, support innovation, and strengthen Europe’s strategic autonomy in health and life sciences, as a coordinated approach is essential to avoid regulatory fragmentation, foster the biotech ecosystem, and secure the availability of critical biotech-derived medicines;

Or. en

Amendment 239

Stine Bosse, Billy Kelleher

Motion for a resolution

Paragraph 7 a (new)

Motion for a resolutionAmendment
7 a. Calls for recognition that public sector innovators, e.g. university hospitals, should be able to apply for regulatory approval through processes and fees adapted to not-for-profit actors; underlines that the current regulatory framework fits commercial products whereas non-commercial interventions with high societal value for patients face significant barriers for approval;

Or. en

Amendment 240

Ignazio Roberto Marino

Motion for a resolution

Paragraph 7 a (new)

Motion for a resolutionAmendment
7 a. Emphasises that the approval of biotechnology products, such as monoclonal antibodies, gene therapies, and mRNA-based treatments, should be based on thorough, independent, and long-term assessments of health risks; calls for a precautionary approach that focuses on preventing harm rather than reacting to it after it occurs;

Or. en

Amendment 241

Michalis Hadjipantela

Motion for a resolution

Paragraph 7 a (new)

Motion for a resolutionAmendment
7 a. Calls on the Commission to evaluate existing regulatory fragmentations for healthcare biotech products and devices, and to establish a centralised coordinated procedure, with the support of the European Medicines Agency (EMA), ensuring safety, efficacy and evaluating GMO-related topics;

Or. en

Amendment 242

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 7 a (new)

Motion for a resolutionAmendment
7 a. Stresses that, for any regulatory reform to be effective, the European Commission and the Member States must allocate adequate resources for staffing and training national regulatory authorities, ensuring their capacity to assess incoming innovations in a timely and efficient manner;

Or. en

Amendment 243

András Tivadar Kulja

Motion for a resolution

Paragraph 7 a (new)

Motion for a resolutionAmendment
7 a. Calls on the Commission to evaluate existing regulatory fragmentations for healthcare biotech products and devices, and to establish a centralised coordinated procedure, with the support of the European Medicines Agency (EMA), ensuring safety and efficacy;

Or. en

Amendment 244

Aurelijus Veryga

Motion for a resolution

Paragraph 7 a (new)

Motion for a resolutionAmendment
7 a. Calls on the Commission to develop an EU-level master file framework for ATMP platform technologies to reduce duplicative submissions and enable efficient cross-product regulatory review;

Or. en

Amendment 245

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 7 b (new)

Motion for a resolutionAmendment
7 b. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation while ensuring high safety and ethical standards; Underlines the need for greater regulatory coherence, including streamlined procedures for clinical trial amendments, harmonised ethics reviews, and operational improvements in the Clinical Trials Information System (CTIS);

Or. en

Amendment 246

Aurelijus Veryga

Motion for a resolution

Paragraph 7 b (new)

Motion for a resolutionAmendment
7 b. Calls on the Commission to maintain efforts aimed at harmonising and streamlining the EU clinical trials framework by increasing efficiency and transparency in approval processes across Member States, reducing administrative delays, and ensuring early planning mechanisms;

Or. en

Amendment 247

András Tivadar Kulja

Motion for a resolution

Paragraph 7 c (new)

Motion for a resolutionAmendment
7 c. Stresses the need for a harmonised and streamlined clinical trials framework ensuring increased efficiency and transparency in approval processes across Member States, significantly reducing administrative delays, including reducing timelines fro approvals of clinical trials, and fostering cross -border collaboration and alignment; calls for increased coordination for innovative biotechnologies, including when using In Vitro Diagnostics (IVDs) and Medical Devices (MDs) for assessments of clinical trials involving drug -device combination products; calls for a targeted revision of the Clinical Trials Regulation ;

Or. en

Amendment 248

Aurelijus Veryga

Motion for a resolution

Paragraph 7 c (new)

Motion for a resolutionAmendment
7 c. Calls for the EU Biotech Act to simplify the current regulatory framework to support innovation while ensuring high safety and ethical standards; notes the need for greater regulatory coherence, including streamlined procedures for clinical trial, harmonised ethics reviews, and operational improvements in the Clinical Trials Information System (CTIS);

Or. en

Amendment 249

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 7 c (new)

Motion for a resolutionAmendment
7 c. Calls on the Commission to develop an EU-level master file framework for advanced therapy medicinal product (ATMP) platform technologies in order to reduce duplicative submissions and enable efficient cross-product regulatory assessment;

Or. en

Amendment 250

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 8

Motion for a resolutionAmendment
8. Recognises the challenges biotechnology companies face in navigating the regulatory framework and highlights the need for support mechanisms, such as the EU biotech hub;deleted

Or. en

Amendment 251

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 8

Motion for a resolutionAmendment
8. Recognises the challenges biotechnology companies face in navigating the regulatory framework and highlights the need for support mechanisms, such as the EU biotech hub;8. Recognises the challenges biotechnology companies face in navigating the EU regulatory framework and highlights the need for support mechanisms, such as the EU Biotech Hub; underlines the importance of identifying and addressing regulatory and market barriers that may hinder the establishment, retention or scale-up of biotechnology companies in Europe; stresses the importance of maintaining high safety and quality standards as a competitive advantage of EU-approved products;

Or. en

Amendment 252

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 8

Motion for a resolutionAmendment
8. Recognises the challenges biotechnology companies face in navigating the regulatory framework and highlights the need for support mechanisms, such as the EU biotech hub;8. Encourages the initiative to develop regulatory innovations that facilitate biotechnology companies' navigation of the regulatory framework and highlights the need for support mechanisms, such as the Union’s Biotechnology Hub, as well as the benefits of early communication development between developers and regulatory bodies;

Or. en

Amendment 253

Ignazio Roberto Marino

Motion for a resolution

Paragraph 8

Motion for a resolutionAmendment
8. Recognises the challenges biotechnology companies face in navigating the regulatory framework and highlights the need for support mechanisms, such as the EU biotech hub;8. Recognises the challenges biotechnology companies face in navigating the regulatory framework and highlights the need for support mechanisms, such as the EU biotech hub; Insists that these support mechanisms must prioritise public health, safety, environmental protection, and democratic oversight;

Or. en

Amendment 254

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Paragraph 8

Motion for a resolutionAmendment
8. Recognises the challenges biotechnology companies face in navigating the regulatory framework and highlights the need for support mechanisms, such as the EU biotech hub;8. Recognises the challenges faced by biotechnology companies, in particular start-ups and SMEs, in managing the regulatory framework and stresses the need for support mechanisms such as the EU Biotechnology Platform;

Or. en

Amendment 255

Viktória Ferenc, Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 8 a (new)

Motion for a resolutionAmendment
8 a. Underlines that personalised medicine represents a transformative advancement in the treatment of rare diseases; notes that emerging therapies have demonstrated significant potential in correcting pathogenic genetic mutations; further emphasises that the identification of biomarkers, in conjunction with advanced diagnostic methodologies, enables the development and application of targeted therapeutic interventions tailored to individual patient profiles;

Or. en

Amendment 256

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 8 a (new)

Motion for a resolutionAmendment
8 a. Highlights the potential of regulatory frameworks such as the hospital exemption not only to improve accessibility to innovative therapies but also to build research environments linked to clinical practice that enable the subsequent development of marketable innovations in collaboration with industry;

Or. en

Amendment 257

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 8 a (new)

Motion for a resolutionAmendment
8 a. Calls on the Commission to fundamentally restructure the EU regulatory system to ensure a holistic approach that follows a product throughout its entire lifecycle, including through the simplification of pre-clinical, clinical, marketing authorisation and post-marketing requirements;

Or. en

Amendment 258

Waldemar Buda

Motion for a resolution

Paragraph 8 a (new)

Motion for a resolutionAmendment
8 a. Calls for the simplification and acceleration of registration procedures for medicinal products developed in the EU, including dedicated regulatory tracks, to strengthen the competitiveness of the pharmaceutical industry and shorten time to market for innovative therapies;

Or. en

Amendment 259

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 8 a (new)

Motion for a resolutionAmendment
8 a. Calls on the Commission to adapt authorisation procedures under the future EU Biotech Act to enable access to emerging biological therapies, through proportionate and flexible regulatory approaches, while maintaining high standards of safety, quality and efficacy;

Or. en

Amendment 260

Ignazio Roberto Marino

Motion for a resolution

Paragraph 8 a (new)

Motion for a resolutionAmendment
8 a. Stresses the importance of coordinated scientific guidance between regulatory authorities across different frameworks to support the development of combination products, including medicines, medical devices, and substances of human origin;

Or. en

Amendment 261

Michalis Hadjipantela

Motion for a resolution

Paragraph 8 a (new)

Motion for a resolutionAmendment
8 a. Calls on the Commission to review the GMO framework and its interplay with ATMPs to reduce the barriers and enable the conduction of multi-country clinical trials;

Or. en

Amendment 262

Jessica Polfjärd

Motion for a resolution

Paragraph 8 a (new)

Motion for a resolutionAmendment
8 a. Calls on the Commission to assess existing regulatory fragmentations in the biotechnology field;

Or. en

Amendment 263

Aurelijus Veryga

Motion for a resolution

Paragraph 8 b (new)

Motion for a resolutionAmendment
8 b. Calls for the application of a risk-based approach to combined clinical trials and clinical investigations/performance studies (CI/PS) involving low-risk medical devices (MDs) or in vitro diagnostics (IVDs) to reduce unnecessary regulatory burden while maintaining patient safety and data integrity; calls on the Commission to reduce timelines for approvals of clinical trials to 30 days from currently over 100 days, with a risk-based assessment;

Or. en

Amendment 264

Viktória Ferenc, Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 8 b (new)

Motion for a resolutionAmendment
8 b. Calls for the EU Biotech Act to simplify the current regulatory framework in order to support innovation, shorten the time for biotech innovations to reach the market, while ensuring high safety standards; encourages to consider international best practices to support regulatory streamlining and maintain global competitiveness;

Or. en

Amendment 265

Ignazio Roberto Marino

Motion for a resolution

Paragraph 8 b (new)

Motion for a resolutionAmendment
8 b. Calls for increased EU investment in domestic biomanufacturing capacity, including platforms for advanced therapy medicinal products (ATMPs) and biologics, in order to reduce strategic dependencies and secure supply chain continuity during crises;

Or. en

Amendment 266

Jessica Polfjärd

Motion for a resolution

Paragraph 8 b (new)

Motion for a resolutionAmendment
8 b. Encourages the Commission to explore means of addressing regulatory fragmentations that pose a hindrance to innovation; stresses particularly the need for a clear, coherent and efficient regulatory environment for clinical trials;

Or. en

Amendment 267

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 8 b (new)

Motion for a resolutionAmendment
8 b. Highlights the importance of specific support schemes for the development of therapies for orphan medicines through frameworks such as unmet medical needs, conditional authorizations, and health technology assessment mechanisms;

Or. en

Amendment 268

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin

Motion for a resolution

Paragraph 8 c (new)

Motion for a resolutionAmendment
8 c. Encourages the European Commission to support off-patent led innovation, including that driven by the biosimilar medicines industry, as a contributor to affordable innovation, helping to ease pressure on healthcare budgets while advancing equitable and timely access for patients;

Or. en

Amendment 269

Ignazio Roberto Marino

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics;deleted

Or. en

Amendment 270

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics;9. Encourages the use of next-generation regulatory and HTA sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics; Strongly encourages the Commission to expand the scope of regulatory sandboxes to include emerging technologies at the intersection of medicinal products, medical devices and in vitro diagnostic medical devices (MDR & IVDR), artificial intelligence, substances of human origin (SoHO), and other cross-sectoral innovations, in order to ensure that the sandboxes are fit for purpose; further encourages the use of these sandboxes to test the effectiveness of a product-centred regulatory framework that enables seamless continuity of knowledge and assessments from initial clinical applications through to the granting of marketing authorisation;

Or. en

Amendment 271

Aurelijus Veryga

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics;9. Encourages the use of regulatory and HTA sandboxes to test emerging biotechnologies within a controlled and adaptable framework that ensures safety, respects bioethical standards, and includes appropriate guardrails to prevent the development of parallel regulatory pathways; calls for the involvement of the EMA in the assessment and design of such sandboxes to ensure coherence with the Union’s regulatory framework;

Or. en

Amendment 272

András Tivadar Kulja

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics;9. Encourages the use of regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics; and to ensure that appropriate safeguards are established to prevent these from evolving into parallel regulatory frameworks; Calls on EMA consultation and oversight in sandbox assessment and design;

Or. en

Amendment 273

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics;9. Encourages the use of next-generation regulatory sandboxes as established under Regulation 2023/0131 to test emerging biotechnologies in a secured, controlled, adaptable framework that ensures a high level of patient safety, protection of public health and respect for bioethics;

Or. en

Amendment 274

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics;9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics; calls for EU-wide collaboration to foster mutual learning between Member States;

Or. en

Amendment 275

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics;9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics as proposed in the revision of the general EU pharmaceutical legislation;

Or. en

Amendment 276

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics;9. Encourages the use of thorough risk assessments and high regulatory standards to test emerging human-centered biotechnologies in a controlled, adaptable framework that ensures safety, animal welfare and respect for bioethics;

Or. en

Amendment 277

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics;9. Encourages the use of regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensure EU safety, efficacy and quality standards;

Or. en

Amendment 278

Billy Kelleher

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Encourages the use of next-generation regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics;9. Encourages the use of regulatory sandboxes to test emerging biotechnologies in a controlled, adaptable framework that ensures safety and respect for bioethics;

Or. en

Amendment 279

Christine Anderson

Motion for a resolution

Paragraph 9 a (new)

Motion for a resolutionAmendment
9 a. Calls for independent, long-term safety evaluations of mRNA-based therapeutics and vaccines, including research into potential unintended effects such as immune dysregulation, biodistribution, and rare adverse events; emphasizes the importance of independent data review and transparency in clinical trial reporting to maintain public trust;

Or. en

Amendment 280

Ignazio Roberto Marino

Motion for a resolution

Paragraph 9 a (new)

Motion for a resolutionAmendment
9 a. Calls on the Commission to publish a report on how current EU legislation on biotechnology and biomanufacturing is being implemented, including an assessment of existing gaps and regulatory barriers that may hinder the sector’s growth and contribute to the EU’s loss of clinical research market share to global competitors;

Or. en

Amendment 281

Aurelijus Veryga

Motion for a resolution

Paragraph 9 a (new)

Motion for a resolutionAmendment
9 a. Calls for greater regulatory flexibility and modernisation to accommodate the increasing number of biotechnology therapies in development, including the adoption of fit-for-purpose requirements, proportionate quality controls, and updated technical standards;

Or. en

Amendment 282

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 9 a (new)

Motion for a resolutionAmendment
9 a. Stresses the need to develop regulatory mechanisms that allow biological therapies to evolve over their lifecycle, including the ability to update or adapt composition or manufacturing processes, where supported by scientific or clinical evidence;

Or. en

Amendment 283

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 9 a (new)

Motion for a resolutionAmendment
9 a. Recalls the importance of improving interoperability and open availability of drug and clinical trial databases to facilitate collaboration and the scaling up of research projects;

Or. en

Amendment 284

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 9 a (new)

Motion for a resolutionAmendment
9 a. Calls for the Biotech Act to present a common, simplified and harmonised clinical trials framework that allows innovation adoption in clinical research;

Or. en

Amendment 285

Ignazio Roberto Marino

Motion for a resolution

Paragraph 9 b (new)

Motion for a resolutionAmendment
9 b. Calls for the upcoming Biotech Act to introduce a simplified, harmonised clinical trials framework that supports the integration of innovation into clinical research; urges the creation of clear guidelines for the use of scientific and real-world evidence (RWE) in both regulatory and health technology assessment (HTA) decisions, ensuring transparency in how this data is generated and used;

Or. en

Amendment 286

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 9 b (new)

Motion for a resolutionAmendment
9 b. Points out that while security standards must be the highest in all cases, audit requirements must be particularly strengthened when applying for public funding, and that this must be accompanied by accessibility commitments in return for the funding received;

Or. en

Amendment 287

Aurelijus Veryga

Motion for a resolution

Paragraph 9 b (new)

Motion for a resolutionAmendment
9 b. Calls on the Commission and EMA to consider establishing a dedicated Biotech Scientific Advisory Panel within the EMA to provide consistent and expert guidance, and to integrate this panel into the agency’s existing scientific advice process;

Or. en

Amendment 288

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Paragraph 9 c (new)

Motion for a resolutionAmendment
9 c. Highlights the role of funds and programs such as Horizon and EU4Health in supporting the development of the biotechnology sector and the research use of health data and the implementation of its solutions in our healthcare systems;

Or. en

Amendment 289

Ignazio Roberto Marino

Motion for a resolution

Paragraph 9 c (new)

Motion for a resolutionAmendment
9 c. Encourages the use of cloud-based technologies to support regulatory assessments throughout the process from clinical trial applications to marketing authorisation and its ongoing management;

Or. en

Amendment 290

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou

Motion for a resolution

Paragraph 9 d (new)

Motion for a resolutionAmendment
9 d. Emphasizes the importance of establishing regulatory mechanisms that enable biological therapies, including biosimilars, to evolve throughout their lifecycle, permitting updates or adaptations to their composition or manufacturing processes when supported by scientific or clinical evidence, while ensuring high standards of safety, quality, and efficacy are maintained;

Or. en

Amendment 291

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Paragraph 9 e (new)

Motion for a resolutionAmendment
9 e. Calls for the strengthening of regulatory science expertise and the creation of clear, specific guidelines to enable thorough assessment of the quality, safety, and effectiveness of emerging biological therapies, including, where appropriate, the use of real-world evidence;

Or. en

Amendment 292

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 10

Motion for a resolutionAmendment
10. Notes the growing role of artificial intelligence (AI) in healthcare, especially in personalised medicine; calls on the Commission to create sector-specific guidelines for AI in diagnosis and treatment;10. Notes the growing role of artificial intelligence (AI) in healthcare, particularly in personalised medicine; calls on the Commission to develop sector-specific guidelines for the application of AI in diagnosis, treatment, and clinical research, in coherence with the AI Act; encourages the development of harmonised ethical guidelines for the use of AI in clinical trials and throughout the entire lifecycle of medicines; underlines the potential of AI to support more efficient and humane research methods, including the reduction of animal testing;

Or. en

Amendment 293

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 10

Motion for a resolutionAmendment
10. Notes the growing role of artificial intelligence (AI) in healthcare, especially in personalised medicine; calls on the Commission to create sector-specific guidelines for AI in diagnosis and treatment;10. Notes the growing role of artificial intelligence (AI) in healthcare, especially in personalised medicine, contributing, for instance, to the design of bioprocesses and the optimisation of metabolic pathways for biopharmaceuticals. calls on the Commission to create sector-specific guidelines for AI in diagnosis and treatment;

Or. es

Amendment 294

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 10

Motion for a resolutionAmendment
10. Notes the growing role of artificial intelligence (AI) in healthcare, especially in personalised medicine; calls on the Commission to create sector-specific guidelines for AI in diagnosis and treatment;10. Notes with concern the growing role of artificial intelligence (AI) in healthcare, especially in personalised medicine; calls on the Commission to create sector-specific guidelines for AI in diagnosis and treatment and measures to curb the excessive energy use;

Or. en

Amendment 295

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 10

Motion for a resolutionAmendment
10. Notes the growing role of artificial intelligence (AI) in healthcare, especially in personalised medicine; calls on the Commission to create sector-specific guidelines for AI in diagnosis and treatment;10. Highlights the increasingly important role of artificial intelligence (AI) in healthcare, especially in personalized medicine, diagnostics, and its integration into medical devices;

Or. en

Amendment 296

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 10 a (new)

Motion for a resolutionAmendment
10 a. Encourages the development of European standards and best-practice guidelines for validation and certification of digital tools such as the European Virtual Human Twins to be used in pre-clinical and clinical research, in coordination with EMA and HTA bodies for a digital representation of a human health or disease state;

Or. en

Amendment 297

Victor Negrescu

Motion for a resolution

Paragraph 10 a (new)

Motion for a resolutionAmendment
10 a. Calls on the Commission to develop a common European framework for the interoperability and security of health data in biotechnology, including the ethical and safe use of artificial intelligence in diagnosis and treatment, thereby ensuring better integration of digital health systems across the EU;

Or. en

Amendment 298

Laurent Castillo

Motion for a resolution

Paragraph 10 a (new)

Motion for a resolutionAmendment
10a. Recalls that stringent, transparent bioethical rules that are adhered to and monitored are essential if citizens are to have confidence in these technologies; believes that each Member State should be allowed to adopt stricter rules in the field of bioethics;

Or. fr

Amendment 299

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 10 a (new)

Motion for a resolutionAmendment
10 a. Urgently calls on the European Commission to encourage off-patent led innovation, such as that delivered by the biosimilar medicines industry, as a key driver of affordable innovation to deliver on equitable and timely patients access and sustainable healthcare systems;

Or. en

Amendment 300

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 10 a (new)

Motion for a resolutionAmendment
10 a. Points out the need for specific monitoring of AI in diagnosis, treatment, and integrated digital services, within the framework of and considering its connection to the European Health Data Space and its governance architecture;

Or. en

Amendment 301

Ignazio Roberto Marino

Motion for a resolution

Paragraph 10 a (new)

Motion for a resolutionAmendment
10 a. Supports the development and validation of suitable new approach methodologies (NAMs) for the safety assessment of emerging biotechnologies;

Or. en

Amendment 302

Ignazio Roberto Marino

Motion for a resolution

Paragraph 10 b (new)

Motion for a resolutionAmendment
10 b. Calls for stronger coordination among all stakeholders and between Member States to improve the clinical trials environment in Europe; welcomes the ACT EU initiative and the Commission’s plan to explore further opportunities through the upcoming Biotech Act, including possible changes to the Clinical Trials Regulation, to strengthen Europe’s position as a global leader in clinical research;

Or. en

Amendment 303

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Paragraph 10 b (new)

Motion for a resolutionAmendment
10 b. Calls on the Commission to prioritize open-source software and AI, taking into account that they offer a higher level of transparency and security when processing sensitive data, as well as greater control and assurance over the data, without compromising clinical effectiveness;

Or. en

Amendment 304

Adam Jarubas

Motion for a resolution

Paragraph 10 b (new)

Motion for a resolutionAmendment
10 b. Calls on the Commission to boost and expand biosimilar medicines production which is a key to equitable and timely access for patients, to healthcare systems sustainable, strategic and technological autonomy and affordable innovation;

Or. en

Amendment 305

Ignazio Roberto Marino

Motion for a resolution

Paragraph 10 c (new)

Motion for a resolutionAmendment
10 c. Recognises the value of real-world data in improving the evidence base on how medicines are used, how safe they are, and how effective they are in real-life settings, as a complement to data from clinical trials;

Or. en

Amendment 306

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 11

Motion for a resolutionAmendment
11. Recalls that valuable research has been lost due to a lack of follow-up and weak links to market application; stresses the need for mechanisms for the traceability of research outcomes to ensure their effective translation into marketable solutions;11. Recalls that valuable research conducted in the EU has been lost due to a lack of follow-up and weak links to market application; stresses the need for mechanisms to improve the traceability and follow-up of publicly funded research; underlines the importance of a cohesive EU approach to the life sciences ecosystem, including academic and clinical research institutions, regulators, investors and venture capital, start-ups and scale-ups, data infrastructure and AI developers, manufacturers of medicines and medical devices, clinicians and distributors, in order to support biotechnology development at all stages and ensure that innovation leads to effective care for patients within the Union;

Or. en

Amendment 307

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Paragraph 11

Motion for a resolutionAmendment
11. Recalls that valuable research has been lost due to a lack of follow-up and weak links to market application; stresses the need for mechanisms for the traceability of research outcomes to ensure their effective translation into marketable solutions;11. Recalls that the commitment to basic research and scientific excellence are essential for a robust technological base. Notes that valuable research has been lost due to lack of follow-up and weak link with market implementation; stresses that traceability mechanisms for research results need to be in place to ensure that they are effectively translated into marketable solutions;

Or. en

Amendment 308

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 11

Motion for a resolutionAmendment
11. Recalls that valuable research has been lost due to a lack of follow-up and weak links to market application; stresses the need for mechanisms for the traceability of research outcomes to ensure their effective translation into marketable solutions;11. Recalls that valuable research has been lost due to an inadequate follow-up and weak links to healthcare environment application; stresses the need for fit-for-purpose mechanisms for the traceability of research outcomes to ensure their effective translation into clinical solutions;

Or. en

Amendment 309

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 11

Motion for a resolutionAmendment
11. Recalls that valuable research has been lost due to a lack of follow-up and weak links to market application; stresses the need for mechanisms for the traceability of research outcomes to ensure their effective translation into marketable solutions;11. Recalls that valuable research has been lost due to a lack of follow-up and weak links to market application; stresses the need for fit-for-purpose mechanisms for the traceability of research outcomes to ensure their effective translation into marketable solutions;

Or. en

Amendment 310

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 11 a (new)

Motion for a resolutionAmendment
11 a. Calls on the Commission and Member States to support the development of regional biotechnology innovation hubs that integrate GMP (Good Manufacturing Practice) manufacturing, regulatory expertise, clinical infrastructure, and workforce training to accelerate the scale-up and delivery of advanced therapies across the EU;

Or. en

Amendment 311

Waldemar Buda

Motion for a resolution

Paragraph 11 a (new)

Motion for a resolutionAmendment
11 a. Stresses the need to apply a risk-based and phased funding approach to biomedical projects, ensuring that public support aligns with actual development stages, the realities of the R&I and commercialisation cycle in the sector, reduces bureaucratic burden, and incentivises industry-led innovation;

Or. en

Amendment 312

Jessica Polfjärd

Motion for a resolution

Paragraph 11 a (new)

Motion for a resolutionAmendment
11 a. Stresses the need to safeguard the EU’s position in clinical research by enabling fast, efficient, and multinational trials; highlights the need for harmonised regulatory and ethical processes, improved access to expertise and infrastructure, and enhanced cross-border patient recruitment;

Or. en

Amendment 313

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 11 a (new)

Motion for a resolutionAmendment
11 a. Stresses the need for increased research to map and investigate the risks of biotechnology for health and the environment;

Or. en

Amendment 314

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Stresses the need for collaboration between universities, research centres and industry to address all biotechnology development phases;12. Highlights the need for enhanced collaboration between universities, research centres, and industry across all phases of biotechnology development, including biosimilars; emphasizes improving knowledge and technology transfer between academia and industry to ensure that EU-funded biotech and biomanufacturing research effectively translates into commercial applications and industrial deployment, supporting their integration through development hubs and public collaboration and funding mechanisms, as outlined in the Draghi and Letta reports;

Or. en

Amendment 315

Ignazio Roberto Marino

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Stresses the need for collaboration between universities, research centres and industry to address all biotechnology development phases;12. Stresses the need for collaboration between universities, research centres and industry to address all biotechnology development phases; Highlights the need for Framework Programmes to support them through collaborative research and public-private partnerships; Suggests creating a mapping of Technology Transfer Offices in the Member States to provide developers with easy access to comprehensive, real-time information about available support structures in their area;

Or. en

Amendment 316

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Stresses the need for collaboration between universities, research centres and industry to address all biotechnology development phases;12. Stresses the need for multidisciplinary collaboration between universities, hospitals, research centres, contract research organisations, civil society, policy makers and industry, including non-animal NAMs developers, to address all biotechnology development phases; emphasises that public investments should lead to public profits instead of patents for companies;

Or. en

Amendment 317

Emmanouil Fragkos

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Stresses the need for collaboration between universities, research centres and industry to address all biotechnology development phases;12. Stresses the need for collaboration between universities, research centres and industry to address all biotechnology development phases; Highlights the importance of having an environment that is favourable to setting up innovative technology companies in universities and research centres (spin-offs) in the Member States;

Or. el

Amendment 318

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Stresses the need for collaboration between universities, research centres and industry to address all biotechnology development phases;12. Stresses the need for collaboration between universities, research centres, hospitals, patients' organizations and industry to address all biotechnology development phases and highlights the need for Framework Programmes to support them through collaborative research and public-private partnerships, such as Joint Undertaking;

Or. en

Amendment 319

Margarita de la Pisa Carrión, Viktória Ferenc

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Stresses the need for collaboration between universities, research centres and industry to address all biotechnology development phases;12. Stresses the need for collaboration between universities, healthcare centres, research centres and industry to address all biotechnology development phases; underlines the need for better coordination, long-term planning, and improved investment mechanisms to drive impactful outcomes;

Or. en

Amendment 320

Laurent Castillo

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Stresses the need for collaboration between universities, research centres and industry to address all biotechnology development phases;12. Stresses the need for collaboration between universities, hospitals, research centres, patients' associations, start-ups, SMEs and industry to address all biotechnology development phases;

Or. fr

Amendment 321

Aurelijus Veryga

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Stresses the need for collaboration between universities, research centres and industry to address all biotechnology development phases;12. Stresses the need for collaboration between universities, research centres, hospitals and industry to address all biotechnology development phases;

Or. en

Amendment 322

Aurelijus Veryga

Motion for a resolution

Paragraph 12 a (new)

Motion for a resolutionAmendment
12 a. Calls to promote and fund the development of centres of excellence and specialisation, open to both commercial and non-commercial research; underlines the need to support the creation of “ever-warm” clinical trial networks, that remains continuously prepared to initiate trials rapidly, regardless of therapeutic area or sponsor type;

Or. en

Amendment 323

Stine Bosse, Billy Kelleher

Motion for a resolution

Paragraph 12 a (new)

Motion for a resolutionAmendment
12 a. Highlights the need for the EU Life Sciences Strategy and the Biotech Act to make the EU the best place in the world to invest in life sciences and biotechnology R&D, manufacturing and clinical trials; stresses at the same time that these efforts must have a tangible and measurable positive impact for EU citizens;

Or. en

Amendment 324

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 12 a (new)

Motion for a resolutionAmendment
12 a. Stresses the need to improve the knowledge and technology transfer between academia and industry to ensure EU-funded biotech and biomanufacturing research leads to commercial applications and industrial deployment; in that respect recommends the establishment of a coordinated European biobanking infrastructure;

Or. en

Amendment 325

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Paragraph 12 a (new)

Motion for a resolutionAmendment
12 a. Calls on the Commission to take specific measures to promote cooperation between biotechnology companies, academics, and healthcare providers in order to accelerate the development of innovative diagnostics and treatments for patients with autoimmune diseases;

Or. en

Amendment 326

Ignazio Roberto Marino

Motion for a resolution

Paragraph 12 a (new)

Motion for a resolutionAmendment
12 a. Supports increased EU funding and stronger public-private partnerships through Horizon Europe and other programmes to boost biotech development, with a focus on addressing unmet medical needs and supporting SMEs and start-ups;

Or. en

Amendment 327

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 12 a (new)

Motion for a resolutionAmendment
12 a. Emphasizes the need to close the gap between preclinical research and clinical development as a key factor for integrating the university environment;

Or. en

Amendment 328

Stine Bosse, Billy Kelleher

Motion for a resolution

Paragraph 12 b (new)

Motion for a resolutionAmendment
12 b. Is convinced that the EU Life Sciences Strategy should be continuously evaluated with key KPIs, and its approach re-adjusted, based on how it delivers for citizens and for EU competitiveness; proposes that patient-centric KPIs should include higher quality of life (QoL), longer lifespans, and better access and higher availability of innovative and generic medical products, including therapies, medical devices and combination products; proposes furthermore that competitiveness-centric KPIs should include the production of life sciences and biotech patents vs. other regions, foreign direct investment (FDI) into research and manufacturing vs. other regions, faster time to market for innovative medical products, translational research vs. other regions, as well as public and private capital raised for successful biotechnology start-ups and scale-ups vs. other regions;

Or. en

Amendment 329

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 12 b (new)

Motion for a resolutionAmendment
12 b. Recalls the need to support university ecosystems and their infrastructure, as well as the importance of developing health centres of research excellence to strengthen their research network;

Or. en

Amendment 330

Stine Bosse, Billy Kelleher

Motion for a resolution

Paragraph 12 c (new)

Motion for a resolutionAmendment
12 c. Encourages structured EU support to growing and connecting excellent biotechnology Innovation Districts in the EU with sufficient capacity, resources and scientific edge to promote new groundbreaking biotechnology discoveries, innovation and commercialisation;

Or. en

Amendment 331

Adam Jarubas

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Highlights the need to guarantee intellectual property (IP) protection and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation;13. Highlights the need to guarantee intellectual property (IP) protection while ensuring timely entrance into the market of biosimilar medicines at the loss of exclusivities (so called Day 1 launch). To achieve this the revision of the Pharmaceutical legislation should deliver on a clarified Bolar clause; at the same time calls urgently on the European Commission to revise the SPC manufacturing waiver, both for export and Day1 launch, to enable biosimilar producers to remain competitive vis a vis non-EU producers; to manage sector-specific investment risks, fostering a secure environment for health innovation and equitable and timely access to medicines;

Or. en

Amendment 332

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Highlights the need to guarantee intellectual property (IP) protection and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation;13. Highlights the need to improve the intellectual property protection system and other reward mechanisms such as subscription and shared-risk models or joint research and procurement programs, in order to address the specific investment requirements of the sector, fostering a dynamic and secure environment for health innovation; as well as equitable and timely access to medicines, while ensuring Day-1 entry after the expiration of patents of biosimiliar products onto the Unions market;

Or. en

Amendment 333

Ignazio Roberto Marino

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Highlights the need to guarantee intellectual property (IP) protection and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation;13. Highlights the need to guarantee intellectual property (IP) to manage sector-specific investment risks and create a secure environment for health innovation; stresses, however, that IP rules must not limit fair and affordable access to biotechnology-based health solutions; calls for a balanced innovation system that responds to public health needs, ensures data-sharing obligations and guarantees fairness and sustainability;

Or. en

Amendment 334

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Highlights the need to guarantee intellectual property (IP) protection and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation;13. Highlights the need to guarantee intellectual property (IP) rights protection while ensuring that biosimilar medicines can enter the market on Day 1 after IP expiry; stresses the need for a well functioning harmonised and clear Bolar exemption, fostering a secure environment for healthcare innovation while ensuring access to medicines for all patients;

Or. en

Amendment 335

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Highlights the need to guarantee intellectual property (IP) protection and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation;13. Highlights the need to guarantee intellectual property (IP) protection -including that of products, technologies, biotechnological processes, or their specific applications- and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation;

Or. en

Amendment 336

Aurelijus Veryga

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Highlights the need to guarantee intellectual property (IP) protection and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation;13. Highlights the need to provide a robust and globally competitive intellectual property (IP) protection system and tackle licencing problems to manage sector-specific investment risks, fostering an enabling environment for health innovation while ensuring access to medicines for all patients in need;

Or. en

Amendment 337

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Highlights the need to guarantee intellectual property (IP) protection and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation;13. Highlights the need to guarantee that intellectual property (IP) protection does not lead to monopolisation, biopiracy, and ensures fair and equitable benefit sharing, and accessibility and affordability of medical products and care, fostering a secure environment for health innovation;

Or. en

Amendment 338

Laurent Castillo

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Highlights the need to guarantee intellectual property (IP) protection and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation;13. Highlights the need to guarantee intellectual property (IP) protection and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation and thus enabling patients to access these innovations;

Or. fr

Amendment 339

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Highlights the need to guarantee intellectual property (IP) protection and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation;13. Highlights the need to provide a robust and globally competitive intellectual property (IP) protection system and tackle licencing problems to manage sector-specific investment risks, fostering a secure environment for health innovation;

Or. en

Amendment 340

Ignazio Roberto Marino

Motion for a resolution

Paragraph 13 a (new)

Motion for a resolutionAmendment
13 a. Stresses the need to ensure timely and equitable access to biosimilar medicines across the EU; underlines the importance of allowing biosimilars to enter the market immediately after the expiry of data and market protection periods for originator biologics; expresses concern about frequent delays caused by litigation strategies that block access to more affordable treatments and place a financial burden on national healthcare systems; urges the Commission to assess and address the impact of such practices;

Or. en

Amendment 341

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 13 a (new)

Motion for a resolutionAmendment
13 a. Underlines the importance of ensuring that regulatory and access frameworks are adapted to the specific characteristics of emerging biological therapies; encourages the development of proportionate pathways for clinical evidence generation, quality standards, and lifecycle management to facilitate their safe and effective integration into healthcare systems.

Or. en

Amendment 342

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 13 a (new)

Motion for a resolutionAmendment
13 a. Underlines that the genetic information contained in humans and all other living organisms is a public good, and should not be patented;

Or. en

Amendment 343

Jessica Polfjärd

Motion for a resolution

Paragraph 13 a (new)

Motion for a resolutionAmendment
13 a. Emphasizes the importance of strong intellectual property protection for promoting innovation in the EU;

Or. en

Amendment 344

Ignazio Roberto Marino

Motion for a resolution

Paragraph 13 b (new)

Motion for a resolutionAmendment
13 b. Underlines the urgent need for greater transparency in clinical trials; notes that the lack of publicly available data holds back scientific progress, as it prevents researchers from learning from past studies, including those with negative or inconclusive results; warns that this lack of transparency leads to duplication of efforts, waste of resources, and missed opportunities for innovation; calls, therefore, for full disclosure of all clinical trial outcomes as a key element of a strong evidence base and of public health-driven innovation;

Or. en

Amendment 345

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 13 b (new)

Motion for a resolutionAmendment
13 b. Encourages the development of regulatory science capacities and dedicated guidance to support the quality, safety and effectiveness assessment of emerging biological therapies, including the use of real-world evidence where appropriate;

Or. en

Amendment 346

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development;deleted

Or. en

Amendment 347

Ignazio Roberto Marino

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development;14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development; highlights the importance of directing these investments towards biotechnologies that address unmet medical needs, such as rare diseases, antimicrobial resistance, and chronic conditions where traditional treatments have proven inadequate;

Or. en

Amendment 348

Ruggero Razza

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development;14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development; calls on the Commission to support biotechnological research in an effort to improve public health, focusing on rare diseases and oncology and promoting public-private partnerships;

Or. it

Amendment 349

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development;14. Underlines the need to increase public and private investment in biotechnology, especially in the early stages of development, including dedicated financing instruments such as seed and venture capital, public-private co-investment vehicles and risk-sharing mechanism to overcome the funding gap faced by start-ups and scale-ups;

Or. en

Amendment 350

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development;14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development, taking into account the long and complex development timelines of biomedical projects, which require structured phasing of research, development, and commercialization stages;

Or. en

Amendment 351

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development;14. Underlines the need for increased public and private investment in biotechnology in early-stage development and when relevant in late-stage development; stresses the importance of public funding in basic research as a key step in the biotech value chain;

Or. en

Amendment 352

Laurent Castillo

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development;14. Underlines the need for increased public and private partnerships and investment in biotechnology, especially in early-stage development to provide leverage;

Or. fr

Amendment 353

Aurelijus Veryga

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development;14. Underlines the need for increased public and private investment in biotechnology to accelerate early discovery initiatives, optimise clinical trials, and build resilient research infrastructure across Europe;

Or. en

Amendment 354

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development;14. Emphasizes the need to increase public and private investment in biotechnology, especially in the early stages of development, aiming progressively to reach an investment target of 3% of GDP by 2030;

Or. en

Amendment 355

Aurelijus Veryga

Motion for a resolution

Paragraph 14 a (new)

Motion for a resolutionAmendment
14 a. Underlines the need to link electronic health data within the European Health Data Space (EHDS) to the EMA's clinical trial map system in order to enable physicians to receive real-time alerts about trials matching their patients’ diagnoses and to make more effective use of the data available through the EMA’s trial maps;

Or. en

Amendment 356

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 14 a (new)

Motion for a resolutionAmendment
14 a. Calls for targeted support for European Virtual Human Twins Initiative and modelling frameworks as enablers of low-cost early-stage therapeutics, improving translational readiness, de-risking investment and clinical trials in biotech innovations;

Or. en

Amendment 357

Ignazio Roberto Marino

Motion for a resolution

Paragraph 14 a (new)

Motion for a resolutionAmendment
14 a. Calls on the Commission to create a coordinated European biotech ecosystem, including a central platform to support regulatory advice, cross-border clinical trials, and access to shared testing and manufacturing infrastructure;

Or. en

Amendment 358

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 14 a (new)

Motion for a resolutionAmendment
14 a. Stresses the need for sustained public-private investment in research infrastructures such as biobanks, databases and cell-culture laboratories;

Or. en

Amendment 359

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 15

Motion for a resolutionAmendment
15. Welcomes the STEP programme as a timely move to boost EU investment in health biotechnology, but notes that current funding remains lower compared to global competitors;15. Welcomes the STEP program as a timely step to boost the Union’s investment in health biotechnology, regrets that European private investments in research, development, and innovation lag behind those of other major economies such as China and the United States; advocates for increased private investment in R&D&I to complement public funds and close the innovation gap with EU competitors; notes that the scaling up and commercialisation of research results remain a major challenge in Europe;

Or. en

Amendment 360

Elena Nevado del Campo, Dolors Montserrat

Motion for a resolution

Paragraph 15

Motion for a resolutionAmendment
15. Welcomes the STEP programme as a timely move to boost EU investment in health biotechnology, but notes that current funding remains lower compared to global competitors;15. Welcomes the STEP programme as a timely move to boost EU investment in health biotechnology, but notes that current funding remains lower compared to global competitors; stresses the need for faster and more agile financing mechanisms, simplified regulatory and operational frameworks, and the development of strong, interconnected value chains;

Or. en

Amendment 361

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 15

Motion for a resolutionAmendment
15. Welcomes the STEP programme as a timely move to boost EU investment in health biotechnology, but notes that current funding remains lower compared to global competitors;15. Notes the STEP programme as a move to boost EU investment in health biotechnology;

Or. en

Amendment 362

Laurent Castillo

Motion for a resolution

Paragraph 15

Motion for a resolutionAmendment
15. Welcomes the STEP programme as a timely move to boost EU investment in health biotechnology, but notes that current funding remains lower compared to global competitors;15. Notes the launch of the STEP programme as a timely move to boost EU investment in health biotechnology, but considers that current funding remains considerably lower compared to global competitors;

Or. fr

Amendment 363

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 15 a (new)

Motion for a resolutionAmendment
15 a. Underlines the importance of building an inclusive and equitable biotech ecosystem that recognises the role of both innovative and biosimilar medicines; Stresses that biosimilar medicines contribute to patient access, healthcare system sustainability, and industrial capacity; Recalls that the complexity of biotech manufacturing applies equally to patented and off-patent biological medicines, and calls for appropriate policy support for all biotech actors;

Or. en

Amendment 364

Emmanouil Fragkos

Motion for a resolution

Paragraph 15 a (new)

Motion for a resolutionAmendment
15a. Considers that all appropriate incentives, including tax incentives, should be used to create relevant business clusters, including ones to re-attract European scientists who have left the EU for competitive third countries;

Or. el

Amendment 365

Waldemar Buda

Motion for a resolution

Paragraph 15 a (new)

Motion for a resolutionAmendment
15 a. Stresses the need to remove biotechnology from regional aid maps, in order to ensure that biotech enterprises, particularly those clustered near major research centres, can access public support regardless of their regional classification;

Or. en

Amendment 366

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 15 a (new)

Motion for a resolutionAmendment
15 a. Calls for strengthened collaboration among all Member States with the support of the Commission and the pooling of knowledge and resources, including leveraging public funding with private investments to address neglected areas;

Or. en

Amendment 367

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 15 a (new)

Motion for a resolutionAmendment
15 a. Encourages the Commission to explore the use of existing instruments such as InvestEU, Horizon Europe, and the Innovation Fund to provide targeted support to early-stage biotechnology projects, in particular in the ATMP space;

Or. en

Amendment 368

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 15 b (new)

Motion for a resolutionAmendment
15 b. Stresses the need to ensure that Europe is adequately equipped and appropriately funds the continuous evolution, improvement and transformation of its biotech research, development and manufacturing ecosystem, including for emerging technological platforms and for follow-on biological medicines (biosimilar medicines), in line with the Innovation Principle;

Or. en

Amendment 369

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 15 c (new)

Motion for a resolutionAmendment
15 c. Stresses that clear and harmonised EU intellectual property rules, including the Bolar exemption, the SPC manufacturing waiver, and the prohibition of patent linkage, would contribute to timely competition and ensure Day-1 market entry after IP expiry; recalls the need to assess the functioning of the SPC manufacturing waiver, adopted in 2019, in order to support EU biosimilar exports, strengthen Europe’s strategic technology capacity and ensure timely patient access to medicines, drawing lessons from past cases where biosimilar competition was delayed;

Or. en

Amendment 370

Laurent Castillo

Motion for a resolution

Paragraph 16

Motion for a resolutionAmendment
16. Stresses the importance of ensuring that biotechnology therapies meet patient needs, highlighting the need to facilitate their commercialisation in the EU and ensure affordability for all;16. Stresses the importance of ensuring that biotechnology therapies meet patient needs by involving them in the various development phases; considers that they should be sold in the Union at a price set by each competent national authority, thereby striking a fair balance between patients' ability to access the therapies and the investments and risks required of their producers before they reach the market; emphasises, too, the development, production, availability and distribution of biosimilar medicines;

Or. fr

Amendment 371

András Tivadar Kulja

Motion for a resolution

Paragraph 16

Motion for a resolutionAmendment
16. Stresses the importance of ensuring that biotechnology therapies meet patient needs, highlighting the need to facilitate their commercialisation in the EU and ensure affordability for all;16. Stresses the importance of ensuring that biotechnology therapies meet patient and society needs, highlighting the need to ensure their timely commercialisation in the EU, and ensure affordability for all, by promoting innovative regulatory and assessment frameworks, and systemic investments, supporting the continued sustainable integration of advanced therapies into the healthcare systems;

Or. en

Amendment 372

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 16

Motion for a resolutionAmendment
16. Stresses the importance of ensuring that biotechnology therapies meet patient needs, highlighting the need to facilitate their commercialisation in the EU and ensure affordability for all;16. Stresses the importance of ensuring that biotechnology therapies meet patient needs, highlighting the need to facilitate their timely commercialisation in the EU with a continued sustainable integration of innovative therapies into healthcare systems and ensure affordability for all;

Or. en

Amendment 373

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Paragraph 16

Motion for a resolutionAmendment
16. Stresses the importance of ensuring that biotechnology therapies meet patient needs, highlighting the need to facilitate their commercialisation in the EU and ensure affordability for all;16. Stresses the importance of ensuring that biotechnological therapies meet patients' needs, highlighting the necessity to facilitate their commercialization within the Union and to guarantee fair market prices that reflect the return on public investment in their development;

Or. en

Amendment 374

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 16

Motion for a resolutionAmendment
16. Stresses the importance of ensuring that biotechnology therapies meet patient needs, highlighting the need to facilitate their commercialisation in the EU and ensure affordability for all;16. Stresses the importance of ensuring that biotechnology therapies meet patient needs, highlighting the need to facilitate their distribution in the EU and ensure accessibility and affordability for all;

Or. en

Amendment 375

Ignazio Roberto Marino

Motion for a resolution

Paragraph 16

Motion for a resolutionAmendment
16. Stresses the importance of ensuring that biotechnology therapies meet patient needs, highlighting the need to facilitate their commercialisation in the EU and ensure affordability for all;16. Stresses the importance of ensuring that biotechnology therapies meet patient needs, highlighting the need to facilitate their equal distribution in the EU and ensure affordability for all;

Or. en

Amendment 376

Waldemar Buda

Motion for a resolution

Paragraph 16 a (new)

Motion for a resolutionAmendment
16 a. Recalls that, despite their proven value, small-molecule innovations are under-exploited in current EU programmes, often due to priorities favouring larger, biologic-based therapies; calls for dedicated incentives, funding mechanisms, and translational support for the development of small-molecule therapies, which play a key role in treating both common and rare diseases;

Or. en

Amendment 377

Ignazio Roberto Marino

Motion for a resolution

Paragraph 16 a (new)

Motion for a resolutionAmendment
16 a. Emphasises that, as biotechnology therapies respond to critical patient and societal needs, their timely commercialisation in the EU must be ensured by promoting innovative regulatory and assessment frameworks, along with systemic investments that support the sustainable integration of these therapies into healthcare systems;

Or. en

Amendment 378

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Paragraph 16 a (new)

Motion for a resolutionAmendment
16 a. Points out the need for the regulatory framework to be sufficiently transparent to allow the evaluation and quantification of such public investment, both of European and foreign origin, in the development of medicines and other medical products, so that this investment results in improved accessibility to medicines;

Or. en

Amendment 379

Victor Negrescu

Motion for a resolution

Paragraph 16 a (new)

Motion for a resolutionAmendment
16 a. Emphasises the importance of guaranteeing equitable access to biotechnological and digital therapies for all social groups, with particular focus on persons with disabilities and vulnerable populations, through the implementation of accessible digital standards and reducing digital divides in health systems;

Or. en

Amendment 380

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 16 a (new)

Motion for a resolutionAmendment
16 a. Recalls that Europeans benefit from biopharmaceutical research and development largely funded outside of Europe; highlights the importance of ensuring appropriate incentives in order to support sustained investment and continued innovation in the sector;

Or. en

Amendment 381

Aurelijus Veryga

Motion for a resolution

Paragraph 16 b (new)

Motion for a resolutionAmendment
16 b. Underlines the need to establish an early-partner framework for rare diseases and breakthrough biotechnologies to accelerate patient access by enabling early use of the European Health Data Space, clinical trial infrastructure, EMA fast-track approval support, and early collaboration with HTA bodies;

Or. en

Amendment 382

Ignazio Roberto Marino

Motion for a resolution

Paragraph 16 b (new)

Motion for a resolutionAmendment
16 b. Stresses the importance of developing a skilled biotech workforce across the EU by promoting education and training in areas such as synthetic biology, AI in life sciences, genomics, and regulatory sciences, while ensuring gender balance and supporting career development;

Or. en

Amendment 383

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 17

Motion for a resolutionAmendment
17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU;17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain and attract skilled workers in the EU; underlines that the growth of the biotechnology sector depends on a highly qualified workforce, encourages the Commission and Member States to explore the establishment of coordinated talent attraction mechanisms, including simplified visa procedures; welcome the importance of the 'Choose Europe for Science' initiative as a strategic opportunity to position the EU as a global hub for scientific careers and innovation; calls on the Commission to accelerate the mutual recognition of professional qualifications within the EU and with like-minded countries, in order to remove mobility barriers for skilled professionals and enhance the competitiveness of the EU biotechnology sector;

Or. en

Amendment 384

Stine Bosse, Billy Kelleher

Motion for a resolution

Paragraph 17

Motion for a resolutionAmendment
17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU;17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU; proposes in this regard that the EU put in place a coordinated visa programme and national one-stop-shops that would help global biotech and STEM talent choose Europe; emphasises that it is important that top academic talent in key priority fields relevant for biotechnology is automatically granted work visas, including their families, upon completion of PhD and postdoctoral programmes in EU Member States;

Or. en

Amendment 385

Billy Kelleher

Motion for a resolution

Paragraph 17

Motion for a resolutionAmendment
17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU;17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU; calls on the European Commission and Member States to increase investment and focus on biotechnology education and professional training. Member States should review visa requirements to support the EU in attracting and retaining talent from across the EU and internationally, and facilitate the movement of lifesciences professionals;

Or. en

Amendment 386

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 17

Motion for a resolutionAmendment
17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU;17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better information on all actors of the EU Biotech ecosystem and better working conditions to attract and retain skilled workers and talented researchers in the EU; supporting training for biotechnological development, promoting European legislation that fosters links between business and academia, including during the training phases;

Or. en

Amendment 387

Laurent Castillo

Motion for a resolution

Paragraph 17

Motion for a resolutionAmendment
17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU;17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU, in particular by fostering partnerships between stakeholders and schools and universities; underlines the need to promote scientific careers, especially among women;

Or. fr

Amendment 388

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin

Motion for a resolution

Paragraph 17

Motion for a resolutionAmendment
17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU;17. Emphasizes the need to promote career opportunities in the life sciences and to address brain drain by offering better conditions not only to retain qualified workers and researchers within the Union but also to attract research and specialist personnel through scientific mobility programs and other incentives for skilled workers to come to the EU;

Or. en

Amendment 389

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 17

Motion for a resolutionAmendment
17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU;17. Stresses the need to raise public awareness of biotechnology’s importance in health, to provide specialised academic training in this field and to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU;

Or. en

Amendment 390

Aurelijus Veryga

Motion for a resolution

Paragraph 17

Motion for a resolutionAmendment
17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU;17. Stresses the need to promote career opportunities in the life sciences, provide training for biotechnological development, and address brain drain by improving working conditions to retain skilled workers in the EU;

Or. en

Amendment 391

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 17

Motion for a resolutionAmendment
17. Stresses the need to promote career opportunities in life sciences and address the brain drain by offering better conditions to retain skilled workers in the EU;17. Stresses the need to promote life sciences career opportunities and education and training on human-centered non-animal NAMs and address brain drain by offering better conditions to retain skilled workers in the EU;

Or. en

Amendment 392

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Paragraph 17 a (new)

Motion for a resolutionAmendment
17 a. Recalls the need for training and continuous updating of all healthcare workers to address and implement the increasing technologization of the healthcare system, in order to guarantee its effectiveness, full development, and integration into clinical practice, with the development of new roles and the redesign of healthcare processes;

Or. en

Amendment 393

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 17 a (new)

Motion for a resolutionAmendment
17 a. Stresses that, in order to remain competitive and respond to evolving needs, the biotech ecosystem must include a comprehensive skills strategy, based on public-private partnerships, to ensure a coordinated and future-oriented approach that addresses emerging challenges and builds the workforce of tomorrow;

Or. en

Amendment 394

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 17 a (new)

Motion for a resolutionAmendment
17 a. Recalls, in this regard, the importance of promoting gender equality in STEM education and career pathways; stresses that the development of the biotech sector represents a key opportunity to enhance the participation of women in science, research and innovation;

Or. en

Amendment 395

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 17 a (new)

Motion for a resolutionAmendment
17a. Stresses the need for greater and wider training in biotechnology, especially throughout the professional career of those involved, with a view to ensuring that those dealing with these products have a minimum standard of knowledge and competence;

Or. es

Amendment 396

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken

Motion for a resolution

Paragraph 17 b (new)

Motion for a resolutionAmendment
17 b. Emphasizes the importance of immigration and its contribution to the sustainability of the healthcare system, as well as the contribution to research from an open, international, and dynamic research environment; highlights the importance of attracting human capital to European universities, early encouragement of research careers through the education system, and the implementation of a gender perspective in STEM careers;

Or. en

Amendment 397

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Paragraph 17 c (new)

Motion for a resolutionAmendment
17 c. Points out the importance of funding university careers through public support mechanisms and the relevance of scholarships for students without resources to advance their university careers, as well as promoting scientific and academic mobility not only through projects but also with scholarships and funding mechanisms for students and academics;

Or. en

Amendment 398

Elena Nevado del Campo, Dolors Montserrat

Motion for a resolution

Paragraph 18

Motion for a resolutionAmendment
18. Highlights the importance of strategic international cooperation in biotechnology; calls on the Commission to support worldwide research initiatives with non-EU like-minded partners;18. Highlights the importance of strategic international cooperation in biotechnology; calls on the Commission to support worldwide research initiatives with non-EU like-minded partners; underlines the need to diversify international partnerships to include a broad range of countries and actors;

Or. en

Amendment 399

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 18

Motion for a resolutionAmendment
18. Highlights the importance of strategic international cooperation in biotechnology; calls on the Commission to support worldwide research initiatives with non-EU like-minded partners;18. Highlights the importance of strategic international cooperation in biotechnology; calls on the Commission to support worldwide research initiatives and regulatory convergence with non-EU like-minded partners while facilitating European SMEs' access to new healthcare markets;

Or. en

Amendment 400

Ignazio Roberto Marino

Motion for a resolution

Paragraph 18

Motion for a resolutionAmendment
18. Highlights the importance of strategic international cooperation in biotechnology; calls on the Commission to support worldwide research initiatives with non-EU like-minded partners;18. Highlights the importance of strategic international cooperation in biotechnology; calls on the Commission to support worldwide research initiatives with non-EU like-minded partners, and to enable such initiatives in EU Framework Programmes;

Or. en

Amendment 401

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 18

Motion for a resolutionAmendment
18. Highlights the importance of strategic international cooperation in biotechnology; calls on the Commission to support worldwide research initiatives with non-EU like-minded partners;18. Highlights the importance of strategic international cooperation in human-centered biotechnology; calls on the Commission to support worldwide research initiatives prioritising human-centered NAMs with non-EU like-minded partners;

Or. en

Amendment 402

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Paragraph 18 a (new)

Motion for a resolutionAmendment
18 a. Emphasises that biosecurity risks must be managed alongside advances in biotechnology and biomanufacturing, ensuring the responsible access to and use of synthetic biology tools, gene-editing technologies, and biological materials. It also calls for enhanced international cooperation on biosecurity lex artis, including the adoption of mandatory screening, attribution and traceability protocols and database integrity, that shall be managed by an European Union public body, aligned with global state of the art, so that EU-based biotech companies can benefit from international best practices while preserving their competitiveness;

Or. en

Amendment 403

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 19

Motion for a resolutionAmendment
19. Urges regulators, healthcare providers, researchers and industry to collaborate on ATMPs to improve oversight through reporting systems;19. Urges regulators, healthcare providers, researchers and industry to collaborate on ATMPs and their life-cycle, including the future off-patent versions, to improve oversight through reporting systems as well as anticipate availability and access affordability while ensuring regulatory coherence and clarity on various requirements across intersecting legal frameworks, to avoid additional regulatory burden;

Or. en

Amendment 404

Ignazio Roberto Marino

Motion for a resolution

Paragraph 19

Motion for a resolutionAmendment
19. Urges regulators, healthcare providers, researchers and industry to collaborate on ATMPs to improve oversight through reporting systems;19. Urges regulators, healthcare providers, researchers and industry to collaborate on ATMPs to improve regulatory consistency and clarify overlapping requirements across different legal frameworks, in order to avoid unnecessary regulatory burdens;

Or. en

Amendment 405

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 19

Motion for a resolutionAmendment
19. Urges regulators, healthcare providers, researchers and industry to collaborate on ATMPs to improve oversight through reporting systems;19. Urges regulators, healthcare providers, researchers and industry to collaborate on ATMPs to improve regulatory coherence and to bring clarity on various requirements across intersecting legal frameworks to avoid additional regulatory burden;

Or. en

Amendment 406

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 19

Motion for a resolutionAmendment
19. Urges regulators, healthcare providers, researchers and industry to collaborate on ATMPs to improve oversight through reporting systems;19. Urges regulators, healthcare providers, researchers and industry to simplify and rationalise the interplay between legislative frameworks, e.g. SoHO and ATMP regulations;

Or. en

Amendment 407

András Tivadar Kulja

Motion for a resolution

Paragraph 19 a (new)

Motion for a resolutionAmendment
19 a. Calls for the simplification and harmonisation of submission data requirements for manufacturing processes; encourages the EMA to provide manufacturing guidance for biotechnology-derived products up to date on basic principles, including where risk to patients might be compromised;

Or. en

Amendment 408

Ignazio Roberto Marino

Motion for a resolution

Paragraph 19 a (new)

Motion for a resolutionAmendment
19 a. Calls on the EU to explore ways to speed up and simplify permit and audit procedures for biotech companies, not only those related to regulatory approvals, to enable faster, more efficient processes and support production scale-up;

Or. en

Amendment 409

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 19 a (new)

Motion for a resolutionAmendment
19 a. Highlights the need to strengthen European programmes that promote women leadership in biotechnology, as well as the consolidation of intergenerational mentoring networks;

Or. en

Amendment 410

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Subheading 3 a (new)

Motion for a resolutionAmendment
Unlocking the full potential of the EU clinical trials framework;

Or. en

Amendment 411

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 19 a (new)

Motion for a resolutionAmendment
19 a. Stresses that EU leadership in clinical trials is one key foundation in ensuring greater investment, commercialisation, and patient access to innovative medical products; is convinced that much greater use of multi-country clinical trials in the EU is a prerequisite to unlock the value of the Single Market and markedly improve the attractiveness of the EU as the premier global market in which to conduct clinical research and to launch innovative medical products;

Or. en

Amendment 412

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 19 b (new)

Motion for a resolutionAmendment
19 b. Calls on the Commission to explore the establishment of a centralised coordination mechanism for clinical research governance, aimed at providing developers of medicines, medical devices and combination products with a more predictable and efficient interface for scientific advice, assessments and authorisations; suggests that the European Medicines Agency could play a coordinating role in this structure, in close cooperation with notified bodies and national competent authorities;

Or. en

Amendment 413

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 19 c (new)

Motion for a resolutionAmendment
19 c. Highlights the need to streamline and make more predictable the work of national ethics committees in approving clinical trials, including cross-border clinical trials; stresses that this could be achieved via clear and unified European Commission guidelines, more centralised review processes supported by standardised EU templates, the harmonisation and the standardisation of responsibilities and ways of working, as seen in e.g. Switzerland and the United Kingdom;

Or. en

Amendment 414

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 19 d (new)

Motion for a resolutionAmendment
19 d. Highlights the importance of further developing and rolling out multi-country platform trials embedded in clinical practice to ensure the efficient and streamlined testing of novel interventions and their effective implementation in EU public healthcare systems;

Or. en

Amendment 415

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 19 e (new)

Motion for a resolutionAmendment
19 e. Underlines that EU clinical trials should be fully representative of Europe’s population, including women, which would be a competitive advantage for the EU life sciences ecosystem as a whole and which would help deliver effective medical products for all EU citizens;

Or. en

Amendment 416

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Subheading 4

Motion for a resolutionAmendment
Support for biotech SMEsSupport for biotech start-ups & SMEs

Or. en

Amendment 417

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Subheading 4

Motion for a resolutionAmendment
Support for biotech SMEsSupport for biotech SMEs and start-ups

Or. en

Amendment 418

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin

Motion for a resolution

Paragraph 20

Motion for a resolutionAmendment
20. Notes that biotechnology thrives in SMEs due to their agility and innovation, which foster the exploration of new ideas;20. Notes that biotechnology is mainly developed in universities and research centres but highlights the role of SMEs in the development and implementation of commercial solutions due to their agility and flexibility, qualities that foster the practical application of new ideas;

Or. en

Amendment 419

Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 20

Motion for a resolutionAmendment
20. Notes that biotechnology thrives in SMEs due to their agility and innovation, which foster the exploration of new ideas;20. Notes that biotechnology thrives in SMEs due to their agility and innovation, which foster the exploration of new ideas; highlights that due to the specific nature of the structure of SMEs they require tailored support to effectively conduct their activities;

Or. en

Amendment 420

Laurent Castillo

Motion for a resolution

Paragraph 20

Motion for a resolutionAmendment
20. Notes that biotechnology thrives in SMEs due to their agility and innovation, which foster the exploration of new ideas;20. Notes that biotechnology thrives in SMEs due to their agility and innovation, which foster the exploration of new ideas, but points out that these SMEs have to contend with a significant and costly regulatory burden when developing and distributing their products;

Or. fr

Amendment 421

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Paragraph 20

Motion for a resolutionAmendment
20. Notes that biotechnology thrives in SMEs due to their agility and innovation, which foster the exploration of new ideas;20. Notes that biotechnology thrives in SMEs and start-ups due to their agility and innovation, which foster the exploration of new ideas;

Or. en

Amendment 422

Dolors Montserrat, Elena Nevado del Campo

Motion for a resolution

Paragraph 21

Motion for a resolutionAmendment
21. Highlights the unique challenges which biotechnology SMEs face due to the high-risk nature of their research and development; stresses the importance of dedicating support and flexible financing models to assist SMEs from early research to commercialisation;21. Highlights the unique challenges which biotechnology SMEs face due to the high-risk nature of their research and development; stresses the importance of dedicating support and flexible financing models to assist SMEs from early research to commercialisation; stresses the need to increase access for SMEs to private investment in research, development and innovation to complement public funding and close the innovation gap with other countries;

Or. en

Amendment 423

Ignazio Roberto Marino

Motion for a resolution

Paragraph 21

Motion for a resolutionAmendment
21. Highlights the unique challenges which biotechnology SMEs face due to the high-risk nature of their research and development; stresses the importance of dedicating support and flexible financing models to assist SMEs from early research to commercialisation;21. Highlights the unique challenges which biotechnology SMEs face due to the high-risk nature of their research and development; stresses the importance of dedicating support and flexible financing models to assist SMEs from early research to commercialisation; Stresses the need to increase access for SMEs to private investment in research, development and innovation to complement public funding and close the innovation gap with USA and China;

Or. en

Amendment 424

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken

Motion for a resolution

Paragraph 21

Motion for a resolutionAmendment
21. Highlights the unique challenges which biotechnology SMEs face due to the high-risk nature of their research and development; stresses the importance of dedicating support and flexible financing models to assist SMEs from early research to commercialisation;21. Highlights the unique challenges which biotechnology SMEs face due to the high-risk nature of their research, development and patent fragmentation across the Union; stresses the importance of dedicating support and flexible financing models to assist SMEs from early research to commercialisation;

Or. en

Amendment 425

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Paragraph 21

Motion for a resolutionAmendment
21. Highlights the unique challenges which biotechnology SMEs face due to the high-risk nature of their research and development; stresses the importance of dedicating support and flexible financing models to assist SMEs from early research to commercialisation;21. Highlights the unique challenges which biotechnology SMEs face due to the high-risk nature of their research and development; stresses the importance of dedicating support and flexible financing models to assist SMEs and start-ups from early research to commercialisation;

Or. en

Amendment 426

Dan-Ştefan Motreanu

Motion for a resolution

Paragraph 21 a (new)

Motion for a resolutionAmendment
21 a. Calls on the Commission to assess options to enhance the robustness of IP rights enforcement and ensure greater legal certainty for innovators in the life sciences sector, including enhancing the deterrent effect of damages under the IP Rights Enforcement Directive for cases of intentional patent infringement, as well as establishing a requirement for patent holders to be notified when applications for marketing authorization of generic and biosimilar products are submitted, as a means to anticipate the early resolution of patent disputes;

Or. en

Amendment 427

Liesbet Sommen, Sérgio Humberto

Motion for a resolution

Paragraph 21 a (new)

Motion for a resolutionAmendment
21 a. Stresses the need to provide adequate and targeted resources to support and strengthen groundbreaking research by biotech SMEs, and urges that this priority be explicitly reflected in the next Multiannual Financial Framework (MFF); also highlights the importance of ensuring that the post-2027 framework programme of Horizon Europe, including the European Innovation Council (EIC), gives particular attention to innovative research projects in the biotechnology and life sciences sectors;

Or. en

Amendment 428

Stine Bosse, Billy Kelleher

Motion for a resolution

Paragraph 21 a (new)

Motion for a resolutionAmendment
21 a. Calls for streamlined access to follow-up funding on all types of research projects based on projects results or outcomes to explore commercialisation, scale-up or implementation of innovative biotechnology-based medical products; underlines that this would help speed up the transition from research grants to commercialisation by scaling up and improving the valorisation of research results;

Or. en

Amendment 429

András Tivadar Kulja

Motion for a resolution

Paragraph 21 a (new)

Motion for a resolutionAmendment
21 a. Recognises that small and medium-sized enterprises (SMEs) are particularly vulnerable to regulatory uncertainty in terms of costs, time, and administrative burden; therefore, stresses the need for a fit-for-purpose Biotech Act that fosters a supportive environment for SMEs to enter the market and develop innovative biotechnological solutions and therapies;

Or. en

Amendment 430

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou

Motion for a resolution

Paragraph 21 a (new)

Motion for a resolutionAmendment
21 a. Calls for the establishment of targeted funding mechanisms and innovation support tailored to SMEs developing novel biological therapies, including bacteriophage-based treatments, acknowledging their significant public health importance especially in combating AMR, and the challenges they face during early-stage development and scale-up;

Or. en

Amendment 431

Victor Negrescu

Motion for a resolution

Paragraph 21 a (new)

Motion for a resolutionAmendment
21 a. Recommends the introduction of dedicated funding mechanisms and support for innovative startups and SMEs in the field of biotechnology and digital health, as well as fostering cross-border collaboration for the development and implementation of digital technologies in health within the STEP platform;

Or. en

Amendment 432

Waldemar Buda

Motion for a resolution

Paragraph 21 a (new)

Motion for a resolutionAmendment
21 a. Calls for support measures for health related companies active in the biotechnology sector, including SMEs and start-ups, to be exempted from the scope of Directive 2013/34/EU, in order to provide the regulatory flexibility necessary for a dynamic, high-risk innovation environment;

Or. en

Amendment 433

Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz

Motion for a resolution

Paragraph 21 a (new)

Motion for a resolutionAmendment
21 a. Calls on the Commission to promote public-private partnerships that bring together start-ups, SMEs, academic groups, and clinical partners fostering and consolidating access to shared tools, datasets, and digital validation frameworks like the European Virtual Human Twins;

Or. en

Amendment 434

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 21 a (new)

Motion for a resolutionAmendment
21 a. Highlights the need for tailored European Investment Bank (EIB), European Innovation Council (EIC) and venture capital funding for innovative biotech SMEs, start-ups and scale-ups working towards launching medical products in the EU;

Or. en

Amendment 435

Viktória Ferenc, Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 21 a (new)

Motion for a resolutionAmendment
21 a. Highlights the need to streamline the set-up and management of multi-country clinical trials within the European Union, with a view to enhancing the Union’s attractiveness as a hub for clinical research;

Or. en

Amendment 436

Viktória Ferenc, Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 21 b (new)

Motion for a resolutionAmendment
21 b. Underlines that decentralised clinical trial approaches, which utilise digital technologies and innovative operational models, enable the conduct of trials without necessitating the physical presence of participants at research sites, thereby improving accessibility and efficiency;

Or. en

Amendment 437

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 21 b (new)

Motion for a resolutionAmendment
21 b. Underlines the need for early and proactive scientific advice and guidance on the regulatory path to market and time to market to be provided by the European Medicines Agency (EMA) to innovative biotech SMEs, start-ups and scale-ups;

Or. en

Amendment 438

Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová

Motion for a resolution

Paragraph 21 c (new)

Motion for a resolutionAmendment
21 c. Calls for streamlined access to follow-up funding on all types of research projects based on projects results or outcomes to explore commercialisation, scale-up or implementation of innovative biotechnology-based medical products; underlines that this would help speed up the transition from research grants to commercialisation by scaling up and improving the valorisation of research results;

Or. en

Amendment 439

Anja Hazekamp, Catarina Martins, Sebastian Everding

Motion for a resolution

Paragraph 22

Motion for a resolutionAmendment
22. Underlines the importance of tailored IP support for biotechnology SMEs; stresses the need to evaluate potential IP rights extensions within the biotechnology sector;deleted

Or. en

Amendment 440

Ignazio Roberto Marino

Motion for a resolution

Paragraph 22

Motion for a resolutionAmendment
22. Underlines the importance of tailored IP support for biotechnology SMEs; stresses the need to evaluate potential IP rights extensions within the biotechnology sector;deleted

Or. en

Amendment 441

Adam Jarubas

Motion for a resolution

Paragraph 22

Motion for a resolutionAmendment
22. Underlines the importance of tailored IP support for biotechnology SMEs; stresses the need to evaluate potential IP rights extensions within the biotechnology sector;22. Underlines the importance of IP frameworks for biotechnology SMEs while ensuring that biosimilar medicines can enter the market at loss of IP expiry; stresses the need to evaluate IP rights within the biotechnology sector that plays a significant role in providing timely and equitable access to biosimilar medicines;

Or. en

Amendment 442

Sérgio Humberto, Liesbet Sommen

Motion for a resolution

Paragraph 22

Motion for a resolutionAmendment
22. Underlines the importance of tailored IP support for biotechnology SMEs; stresses the need to evaluate potential IP rights extensions within the biotechnology sector;22. Underlines that it is crucial to provide individualised intellectual property support to biotechnology SMEs; Stresses the need to maintain a balanced and competitive intellectual property rights framework in the EU in relation to other geo-economic blocs;

Or. en

Amendment 443

Aurelijus Veryga

Motion for a resolution

Paragraph 22

Motion for a resolutionAmendment
22. Underlines the importance of tailored IP support for biotechnology SMEs; stresses the need to evaluate potential IP rights extensions within the biotechnology sector;22. Underlines the importance of tailored IP support for biotechnology SMEs; stresses the need to evaluate potential IP rights extensions within the biotechnology sector; stresses the need to evaluate potential IP rights extensions within the biotechnology sector, including data exclusivity enhancements as an alternative incentive to patent-based exclusivities where appropriate;

Or. en

Amendment 444

Laurent Castillo

Motion for a resolution

Paragraph 22

Motion for a resolutionAmendment
22. Underlines the importance of tailored IP support for biotechnology SMEs; stresses the need to evaluate potential IP rights extensions within the biotechnology sector;22. Underlines the importance of tailored regulatory support, especially IP support for biotechnology SMEs; stresses the need to evaluate potential IP rights extensions within the biotechnology sector, facilitate administrative and regulatory procedures, and establish mechanisms to mobilise public and private capital for biotechnology SMEs;

Or. fr

Amendment 445

Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou

Motion for a resolution

Paragraph 22

Motion for a resolutionAmendment
22. Underlines the importance of tailored IP support for biotechnology SMEs; stresses the need to evaluate potential IP rights extensions within the biotechnology sector;22. Emphasizes the convenience of granting specific incentives to SMEs to promote the integration of university-business programs that enable the commercial development of innovations, whilt also ensuring Day-1 entry after the expiration of patents of biosimiliar products onto the Unions market;

Or. en