amendment list, 17 June 2025
Public health aspects of biotechnology and life sciences
Document SANT-AM-774523 · (2025/2087(INI))
Committee on Public Health
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Text 816 paragraphs
Amendment 446
Dan-Ştefan Motreanu
Motion for a resolution
Paragraph 22
| Motion for a resolution | Amendment |
|---|---|
| 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, including data exclusivity enhancements as an alternative incentive to patent-based exclusivities where appropriate; |
Or. en
Amendment 447
Billy Kelleher
Motion for a resolution
Paragraph 22 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 22 a. Calls on the creation of an EU Biotech Innovation Fund to support researchers, academia, start-ups and SMEs conducting R&D and innovation in healthcare biotechnologies. The fund should also allocate dedicated resources to the European Medicines Agency (EMA) and national competent authorities to support regulatory modernisation, including the development and implementation of pilot projects; it should further contribute to the enhancement, maintenance, and interoperability of databases, digital portals and tools used in regulatory processes. This fund should complement existing EU tools and national funding initiatives, therefore creating a framework for capital investments; |
Or. en
Read the rest (804 paragraphs)
Amendment 448
Galato Alexandraki, Emmanouil Fragkos
Motion for a resolution
Paragraph 22 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 22a. Calls on the Commission to support the use of biotechnology to benefit the European Union's self-sufficiency in medicines, with an emphasis on boosting production by small and medium-sized enterprises, with the provision that full transparency and a focus on public health over corporate profit be ensured, while also guaranteeing high safety standards; |
Or. el
Amendment 449
Viktória Ferenc, Margarita de la Pisa Carrión
Motion for a resolution
Paragraph 22 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 22 a. Underlines the importance of stronger IP protection and the need to support biotech SMEs in leveraging their IP assets to access finance; such measures could include the introduction of IP vouchers, broad access to strategic IP advisory services, and a simplified trademark application process for applicants who do not engage professional representatives; |
Or. en
Amendment 450
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 22 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 22 a. Notes the importance of intellectual property rights as a main asset for SMEs and start-ups to secure investment; recalls the importance to speed up the implementation of the Unitary Patent System by reducing costs, increasing the value of intellectual property and improving predictability for investors; |
Or. en
Amendment 451
Ignazio Roberto Marino
Motion for a resolution
Paragraph 22 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 22 a. Strongly supports shared public/private ownership of biotechnologies developed with the contribution of public funding; stresses the importance of fair and equitable pricing to ensure accessibility for all, particularly in the context of publicly funded research and innovation; |
Or. en
Amendment 452
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 22 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 22 a. Strongly emphasises the need for alignment between the EU Biotech Act and the Pharmaceutical Regulation 2023/0131, particularly concerning incentive mechanisms for innovation in the antimicrobials, regulatory sandbox approaches, and flexible lifecycle management for biologics; |
Or. en
Amendment 453
Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz
Motion for a resolution
Paragraph 22 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 22 a. Calls for dedicated funding instruments and innovation support for SMEs developing novel biological therapies, including bacteriophage-based treatments, recognising their high public health relevance and the challenges associated with early-stage development and scale-up; |
Or. en
Amendment 454
Laurent Castillo
Motion for a resolution
Paragraph 22 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 22a. Calls for State aid rules to be revised to allow national authorities to invest in high-risk biotechnology projects, in particular those developed by biotech start-ups and SMEs; |
Or. fr
Amendment 455
Aurelijus Veryga
Motion for a resolution
Paragraph 22 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 22 a. Calls for a review of state-aid frameworks to enable greater public investment in high-risk stages of biotechnological innovation, particularly for start-ups and SMEs developing disruptive therapies; |
Or. en
Amendment 456
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 22 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 22 b. Strongly emphasises the need for alignment between the EU Biotech Act and the Pharmaceutical Directive 2023/0132, particularly concerning and in particular all the technical, scientific, and safety standards, as well as the safeguards for the accessibility of medicinal products established therein; |
Or. en
Amendment 457
Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz
Motion for a resolution
Paragraph 22 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 22 b. Stresses the importance of ensuring coherence between the EU Biotech Act and the Pharmaceutical Package, in particular with regard to incentive mechanisms for antimicrobial innovation, regulatory sandbox initiatives, and lifecycle flexibility for biologics; |
Or. en
Amendment 458
Ignazio Roberto Marino
Motion for a resolution
Paragraph 22 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 22 b. Highlights the importance of strong ethical oversight in biotechnology, including for AI-based tools; |
Or. en
Amendment 459
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Subheading 5
| Motion for a resolution | Amendment |
|---|---|
| Ethical and legal implications | Ethical, privacy, environmental and legal implications |
Or. en
Amendment 460
Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová
Motion for a resolution
Paragraph 23
| Motion for a resolution | Amendment |
|---|---|
| 23. Highlights that biotechnological advancements can entail risks of misuse or unintended consequences; calls on the Member States and the Commission to adopt a precautionary yet innovation-enabling regulatory approach; | 23. Recognises that biotechnologies brings both opportunities and challenges; calls on the Commission and Member States to develop a balanced regulatory approach that safeguards public trust and strong EU ethical standards while fostering responsible innovation and the rapid uptake of safe and effective technologies; |
Or. en
Amendment 461
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 23
| Motion for a resolution | Amendment |
|---|---|
| 23. Highlights that biotechnological advancements can entail risks of misuse or unintended consequences; calls on the Member States and the Commission to adopt a precautionary yet innovation-enabling regulatory approach; | 23. Highlights that biotechnological advances may entail risks of misuse or unintended consequences; it calls on the Member States and the Commission to adopt an approach that fosters innovation while maintaining the highest standards of safety and reliability in accordance with the state of scientific knowledge; |
Or. en
Amendment 462
Jessica Polfjärd
Motion for a resolution
Paragraph 23
| Motion for a resolution | Amendment |
|---|---|
| 23. Highlights that biotechnological advancements can entail risks of misuse or unintended consequences; calls on the Member States and the Commission to adopt a precautionary yet innovation-enabling regulatory approach; | 23. Recognises that biotechnological advancements can can raise ethical concerns; calls on Member States and the Commission to adopt a balanced regulatory approach, supporting innovation while ensuring strong ethical oversight and safeguarding human rights; |
Or. en
Amendment 463
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 23
| Motion for a resolution | Amendment |
|---|---|
| 23. Highlights that biotechnological advancements can entail risks of misuse or unintended consequences; calls on the Member States and the Commission to adopt a precautionary yet innovation-enabling regulatory approach; | 23. Highlights that biotechnological advancements entails risks of misuse or unintended consequences; calls on the Member States and the Commission to adopt a precautionary regulatory approach, anchored in the One Health principle; |
Or. en
Amendment 464
Jessica Polfjärd
Motion for a resolution
Paragraph 24
| Motion for a resolution | Amendment |
|---|---|
| 24. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare, ensuring that it is always used in favour of patients, safeguards human dignity and life and avoids discrimination; highlights that all practices must avoid trait-selection or eugenic attitudes towards persons with disabilities; | deleted |
Or. en
Amendment 465
Ignazio Roberto Marino
Motion for a resolution
Paragraph 24
| Motion for a resolution | Amendment |
|---|---|
| 24. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare, ensuring that it is always used in favour of patients, safeguards human dignity and life and avoids discrimination; highlights that all practices must avoid trait-selection or eugenic attitudes towards persons with disabilities; | 24. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare that enables the most advanced innovation, ensuring that it is always used in favour of patients, safeguards human dignity and life and avoids discrimination; highlights that all practices must avoid trait-selection or eugenic attitudes towards persons with disabilities or marginalised communities; further underlines the importance of integrating social justice, gender equality, and environmental sustainability into ethical assessments of biotechnological development and use; |
Or. en
Amendment 466
Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová
Motion for a resolution
Paragraph 24
| Motion for a resolution | Amendment |
|---|---|
| 24. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare, ensuring that it is always used in favour of patients, safeguards human dignity and life and avoids discrimination; highlights that all practices must avoid trait-selection or eugenic attitudes towards persons with disabilities; | 24. Emphasises the need for robust ethical oversight mechanisms in biotechnology, ensuring that innovations serve patients' best interests, respect human dignity and promote inclusiveness; encourages open dialogue with civil society, patients and experts to ensure broad societal support for emerging technologies, including gene therapies; |
Or. en
Amendment 467
Ruggero Razza
Motion for a resolution
Paragraph 24
| Motion for a resolution | Amendment |
|---|---|
| 24. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare, ensuring that it is always used in favour of patients, safeguards human dignity and life and avoids discrimination; highlights that all practices must avoid trait-selection or eugenic attitudes towards persons with disabilities; | 24. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare, ensuring that it is always used in favour of patients, safeguards human dignity and life and avoids discrimination; highlights that all practices must avoid trait-selection or eugenic attitudes towards persons with disabilities; considers it imperative that testing of new biotechnology technologies always be subject to strict ethical controls, ensuring complete transparency and information for the public while fully honouring human dignity; |
Or. it
Amendment 468
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 24
| Motion for a resolution | Amendment |
|---|---|
| 24. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare, ensuring that it is always used in favour of patients, safeguards human dignity and life and avoids discrimination; highlights that all practices must avoid trait-selection or eugenic attitudes towards persons with disabilities; | 24. Recalls the obligations arising from the Oviedo Convention for the protection of human rights and human dignity with regard to the applications of Biology and Medicine of 1997 and its protocols; |
Or. en
Amendment 469
Elena Nevado del Campo, Dolors Montserrat
Motion for a resolution
Paragraph 24
| Motion for a resolution | Amendment |
|---|---|
| 24. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare, ensuring that it is always used in favour of patients, safeguards human dignity and life and avoids discrimination; highlights that all practices must avoid trait-selection or eugenic attitudes towards persons with disabilities; | 24. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare, emphasising that scientific advances must guide ethical considerations, ensuring that it is always used in favour of patients, safeguards human dignity and life and avoids discrimination; highlights that all practices must avoid trait-selection or eugenic attitudes towards persons with disabilities; |
Or. en
Amendment 470
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 24
| Motion for a resolution | Amendment |
|---|---|
| 24. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare, ensuring that it is always used in favour of patients, safeguards human dignity and life and avoids discrimination; highlights that all practices must avoid trait-selection or eugenic attitudes towards persons with disabilities; | 24. Stresses the need for strong ethical oversight in the field of biotechnology in healthcare, ensuring that it is always used in favour of patients, safeguards human and animal dignity and life and avoids discrimination; highlights that all practices must avoid trait-selection or eugenic attitudes towards persons with disabilities; |
Or. en
Amendment 471
András Tivadar Kulja
Motion for a resolution
Paragraph 24 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 24 a. Stresses the need for transparent and clear communication on ethical considerations and science-based decision-making; underlines the importance of building and maintaining public trust in modern science and the biotechnology sector by strengthening health literacy, including through accessible formats for communicating new technologies, both for the general population and as part of healthcare professional training; |
Or. en
Amendment 472
Galato Alexandraki, Emmanouil Fragkos
Motion for a resolution
Paragraph 24 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 24a. Stresses that biotechnology in the healthcare sector should not be used to create or enforce standards of eugenics or mass genetic testing, and rejects any attempt at global uniformity in bioethics at the expense of national traditions and values; |
Or. el
Amendment 473
Ignazio Roberto Marino
Motion for a resolution
Paragraph 24 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 24 a. Recognises the role of SMEs and specialised biotech developers in innovation; calls for tailored regulatory and financial support to improve market access and foster competition while ensuring patient safety; |
Or. en
Amendment 474
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 24 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 24 a. Emphasizes that the possibilities offered by biotechnology should be directed exclusively towards therapeutic treatment and not for other purposes such as trait selection; |
Or. en
Amendment 475
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 24 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 24 b. Warns against the use of genetic tests for purposes that lack clinical utility and recalls their prohibition in the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes; |
Or. en
Amendment 476
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 24 c (new)
| Motion for a resolution | Amendment |
|---|---|
| 24 c. Emphasizes that the commercialisation of genetic tests without a health-related purpose is often accompanied by personal data collection practices that do not comply with the European Union’s legal standards regarding consent for data acquisition, processing, and the purposes for which data are used and shared, and urges the Commission to develop mechanisms and protocols to address and prosecute such practices; |
Or. en
Amendment 477
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 24 d (new)
| Motion for a resolution | Amendment |
|---|---|
| 24 d. Highlights that crowdsourcing smartphone data and another similar data collection procedures pose a risk to the consistency of health data and the effectiveness of informed consent. Healthcare professionals must be involved in data collection and ensure the quality of health data for research. These professionals themselves must have access to quality training in these tasks, both from the perspective of the necessary knowledge of the data to be collected and the rights of patients regarding them; |
Or. en
Amendment 478
Jessica Polfjärd
Motion for a resolution
Paragraph 25
| Motion for a resolution | Amendment |
|---|---|
| 25. Recalls that EU legislation should not interfere with national laws in terms of ethics; calls on the Commission to promote cooperation among national ethics committees, ensuring impartiality and involving all parties concerned; | deleted |
Or. en
Amendment 479
Ruggero Razza
Motion for a resolution
Paragraph 25
| Motion for a resolution | Amendment |
|---|---|
| 25. Recalls that EU legislation should not interfere with national laws in terms of ethics; calls on the Commission to promote cooperation among national ethics committees, ensuring impartiality and involving all parties concerned; | 25. Recalls that EU legislation should not interfere with national laws in terms of ethics; calls on the Commission to promote cooperation among national ethics committees, ensuring impartiality and involving all parties concerned; reiterates that the regulation and adoption of biotechnological technologies in the medical field must adhere to the principle of subsidiarity, leaving the Member States to decide on the basis of their own healthcare and cultural priorities; |
Or. it
Amendment 480
Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová
Motion for a resolution
Paragraph 25
| Motion for a resolution | Amendment |
|---|---|
| 25. Recalls that EU legislation should not interfere with national laws in terms of ethics; calls on the Commission to promote cooperation among national ethics committees, ensuring impartiality and involving all parties concerned; | 25. Underlines the importance of EU-level coordination in ethical matters to avoid regulatory fragmentation and ensure a coherent internal market; calls on the Commission to work closely with national ethics committees and stakeholders to define shared principles and best practices, while respecting the principle of subsidiarity; |
Or. en
Amendment 481
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 25
| Motion for a resolution | Amendment |
|---|---|
| 25. Recalls that EU legislation should not interfere with national laws in terms of ethics; calls on the Commission to promote cooperation among national ethics committees, ensuring impartiality and involving all parties concerned; | 25. Calls on the Commission to promote cooperation among national ethics committees, ensuring impartiality and involving all relevant stakeholders, and to promote good practices based on the common constitutional heritage, international human rights treaties ratified by the Member States, the Charter of Fundamental Rights of the EU, the European Convention on Human Rights, and its instruments and protocols; |
Or. en
Amendment 482
Ignazio Roberto Marino
Motion for a resolution
Paragraph 25
| Motion for a resolution | Amendment |
|---|---|
| 25. Recalls that EU legislation should not interfere with national laws in terms of ethics; calls on the Commission to promote cooperation among national ethics committees, ensuring impartiality and involving all parties concerned; | 25. calls on the Commission to provide harmonised ethical guidelines for emerging biotechnologies; promote cooperation among national ethics committees, ensuring impartiality and involving all parties concerned; transparency, and broad stakeholder involvement, while promoting the exchange of best practices and fostering cross-border dialogue on emerging bioethical issues; |
Or. en
Amendment 483
Victor Negrescu
Motion for a resolution
Paragraph 25 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 25 a. Calls on the Commission to initiate a European-wide public consultation and continuous information process on the risks and benefits of biotechnologies, ensuring transparency in decision-making and active involvement of citizens, especially affected communities, in ethical and regulatory debates; |
Or. en
Amendment 484
Jessica Polfjärd
Motion for a resolution
Paragraph 26
| Motion for a resolution | Amendment |
|---|---|
| 26. Calls on the Commission to address ethical concerns regarding gene editing technologies like CRISPR; welcomes the fact that germ line modifications are banned due to their unpredictable impact on individuals and future generations; | deleted |
Or. en
Amendment 485
Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová
Motion for a resolution
Paragraph 26
| Motion for a resolution | Amendment |
|---|---|
| 26. Calls on the Commission to address ethical concerns regarding gene editing technologies like CRISPR; welcomes the fact that germ line modifications are banned due to their unpredictable impact on individuals and future generations; | 26. Stresses the importance of addressing ethical and legal considerations related to emerging gene-editing technologies such as CRISPR, particularly in the context of germline modification; emphasises the need for ongoing dialogue with the scientific community, ethics bodies and the public to ensure responsible and transparent governance of these technologies; |
Or. en
Amendment 486
Laurent Castillo
Motion for a resolution
Paragraph 26
| Motion for a resolution | Amendment |
|---|---|
| 26. Calls on the Commission to address ethical concerns regarding gene editing technologies like CRISPR; welcomes the fact that germ line modifications are banned due to their unpredictable impact on individuals and future generations; | 26. Considers that human embryos and gametes cannot be treated merely as commercial and industrial products; calls on the Commission to address ethical concerns regarding gene editing technologies like CRISPR; welcomes the fact that germ line modifications are banned due to their unpredictable impact on individuals and future generations; |
Or. fr
Amendment 487
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 26
| Motion for a resolution | Amendment |
|---|---|
| 26. Calls on the Commission to address ethical concerns regarding gene editing technologies like CRISPR; welcomes the fact that germ line modifications are banned due to their unpredictable impact on individuals and future generations; | 26. Calls on the Commission to assess the impact of biotechnology on the environment, to reevaluate medical research practices involving animals, and to incorporate a gender perspective in biomedical research; |
Or. en
Amendment 488
Christine Anderson
Motion for a resolution
Paragraph 26 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 26 a. Underlines the need for robust ethical oversight in the deployment of mRNA-based technologies, particularly in vulnerable populations such as children, pregnant women, and the immunocompromised; calls for clear and accessible informed consent procedures that reflect the novel nature of the technology and its potential risks; |
Or. en
Amendment 489
Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová
Motion for a resolution
Paragraph 27
| Motion for a resolution | Amendment |
|---|---|
| 27. Recognises the Universal Declaration on the Human Genome and Human Rights as a guide for ethical and legal frameworks in biotechnology; | deleted |
Or. en
Amendment 490
Jessica Polfjärd
Motion for a resolution
Paragraph 27
| Motion for a resolution | Amendment |
|---|---|
| 27. Recognises the Universal Declaration on the Human Genome and Human Rights as a guide for ethical and legal frameworks in biotechnology; | deleted |
Or. en
Amendment 491
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 27 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 27 a. Emphasises that reducing social inequality and unequal access to healthcare and a greater commitment to prevention and healthy environments are much more important for improving public health than biotechnology and deserve much more structural investments and commitments; |
Or. en
Amendment 492
Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc
Motion for a resolution
Paragraph 27 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 27 a. Emphasises the need to prevent animal mistreatment in testing and develop alternatives as biotechnology advances, while acknowledging that animal testing may still be necessary for replicating organism-wide effects like drug absorption, systemic toxicity, or behavioral outcomes; |
Or. en
Amendment 493
Ignazio Roberto Marino
Motion for a resolution
Paragraph 27 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 27 a. Supports cross-border collaboration and regulatory harmonisation to speed up patient access to safe and effective biotech products; calls for early dialogue between developers, health technology assessment (HTA) bodies, and payers; |
Or. en
Amendment 494
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 27 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 27 b. Expresses its concern that public values are being compromised by the increasing (commercial) use of (digital) DNA data in all kinds of domains and settings, and stresses that issues of privacy, autonomy, security and control, human dignity, justice and power relations call for targeted adjustments to legal frameworks for dealing with DNA data by Direct to consumer genetic testing (DTC-GT) companies, as well as by governments and employers; calls for mandatory measures against the risks of unwanted and unauthorised processing of genetic data in the employment relationship, and stresses that the processing of genetic data of employees and job applicants should only be allowed on the basis of a legal requirement; |
Or. en
Amendment 495
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 27 c (new)
| Motion for a resolution | Amendment |
|---|---|
| 27 c. Stresses the importance of Ethics by Design when setting up systems that combine DNA data and digital technology to support forensic investigation and medical decisions; |
Or. en
Amendment 496
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 27 d (new)
| Motion for a resolution | Amendment |
|---|---|
| 27 d. Stresses the need for citizens to be better informed and involved in DNA data developments, and asks the Commission to establish guidelines for this, and to facilitate processes in which citizens can participate in a democratic debate on the use of DNA data by governments and commercial parties; |
Or. en
Amendment 497
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 27 e (new)
| Motion for a resolution | Amendment |
|---|---|
| 27 e. Underlines that public parties who are outsourcing DNA analyses to (semi-)private parties must be vigilant in ensuring quality, privacy and security, and calls for a more well thought-out governance system for this, with oversight and clear, binding agreements, suggest that it would be proper to differentiate between biotechnology companies active within healthcare and biotechnology companies aimed towards DNA storage and analysis; |
Or. en
Amendment 498
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 27 f (new)
| Motion for a resolution | Amendment |
|---|---|
| 27 f. Notes that technological dependence on international digital platforms such as Google, Amazon and Microsoft is undesirable, as knowledge about our DNA for societal applications is a public good; asks the Commission to assess the data monopoly by companies and the dominance of the major international digital platforms in computing capacity for DNA data using the frameworks of the Digital Services Act, and calls for targeted measures to counter this dependence; |
Or. en
Amendment 499
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 27 g (new)
| Motion for a resolution | Amendment |
|---|---|
| 27 g. Notes that it is essential that digital platforms such as Google, Amazon and Microsoft, when storing and processing DNA data, have obligations imposed on them that are part of responsible handling of public goods; stresses that access to those services must be guaranteed, as must the extent to which information can be exchanged with other services; |
Or. en
Amendment 500
Jessica Polfjärd
Motion for a resolution
Paragraph 28
| Motion for a resolution | Amendment |
|---|---|
| 28. Stresses the importance of data processing in biotechnology research; calls on the Member States to strengthen the protection of health-related personal and genetic data; | deleted |
Or. en
Amendment 501
Ignazio Roberto Marino
Motion for a resolution
Paragraph 28
| Motion for a resolution | Amendment |
|---|---|
| 28. Stresses the importance of data processing in biotechnology research; calls on the Member States to strengthen the protection of health-related personal and genetic data; | 28. Stresses the importance of data processing in biotechnology research; calls on the Member States to strengthen the protection of health-related personal and genetic data, especially in the development of innovative health solutions; underlines that the EU’s existing data protection framework, already offers strong and comprehensive safeguards;urges Member States to ensure proportionate and harmonised implementation to support responsible data use and foster innovation |
Or. en
Amendment 502
Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová
Motion for a resolution
Paragraph 28
| Motion for a resolution | Amendment |
|---|---|
| 28. Stresses the importance of data processing in biotechnology research; calls on the Member States to strengthen the protection of health-related personal and genetic data; | 28. Emphasises the critical role of high-quality biomedical and genetic data in accelerating research and personalised medicine; calls on the Commission to strengthen data governance frameworks that ensure privacy, security, and interoperability, enabling trusted and responsible cross-border data sharing for research and innovation; underlines the strategic importance of the European Health Data Space (EHDS) as a cornerstone for enabling secure access and secondary use of health data across the EU, and calls for its effective implementation to support biomedical innovation and improve patient outcomes; |
Or. en
Amendment 503
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 28
| Motion for a resolution | Amendment |
|---|---|
| 28. Stresses the importance of data processing in biotechnology research; calls on the Member States to strengthen the protection of health-related personal and genetic data; | 28. Emphasises the importance of data processing in biotechnological research; calls on the Commission and the Member States to strengthen the protection of personal and genetic health data, and to establish the necessary governance mechanisms within the framework of the European Health Data Space; |
Or. en
Amendment 504
Margarita de la Pisa Carrión, Viktória Ferenc
Motion for a resolution
Paragraph 28
| Motion for a resolution | Amendment |
|---|---|
| 28. Stresses the importance of data processing in biotechnology research; calls on the Member States to strengthen the protection of health-related personal and genetic data; | 28. Stresses the importance of data processing in biotechnology research while expressing concern about data misuse, breaches, and unclear consent; calls on the Member States to strengthen the protection of health-related personal and genetic data; |
Or. en
Amendment 505
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 28 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 28 a. Stresses the importance of Open Science when doing research with DNA data, emphasises that this should be founded on FAIR principles, meaning that data should be findable, accessible, exchangeable and reusable, allowing researchers to better verify and reuse research results; |
Or. en
Amendment 506
Galato Alexandraki, Emmanouil Fragkos
Motion for a resolution
Paragraph 28 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 28a. Highlights that genetic data processing practices must not lead to a concentration of biomedical power by supranational institutions or private tech giants. Calls for strict controls to be put in place to prevent the commercialisation of the human genome; |
Or. el
Amendment 507
Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz
Motion for a resolution
Paragraph 28 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 28 a. Supports infrastructure development for secure, interoperable, and ethically managed use of biomedical and simulation-derived data to inform integrated, systems-level modelling in clinical research; |
Or. en
Amendment 508
Jessica Polfjärd
Motion for a resolution
Paragraph 29
| Motion for a resolution | Amendment |
|---|---|
| 29. Highlights the legal and ethical challenges of biomedical data in AI systems; stresses the need for human oversight and dynamic validation of AI; | deleted |
Or. en
Amendment 509
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 29
| Motion for a resolution | Amendment |
|---|---|
| 29. Highlights the legal and ethical challenges of biomedical data in AI systems; stresses the need for human oversight and dynamic validation of AI; | 29. Highlights the legal and ethical challenges of biomedical data in AI systems; underscores the need for human oversight and dynamic validation of AI, as well as the use of AI operated remotely from third countries outside the Union whose data protection standards do not meet those of the Union, taking into account the special sensitivity of the processed data; |
Or. en
Amendment 510
Ignazio Roberto Marino
Motion for a resolution
Paragraph 29
| Motion for a resolution | Amendment |
|---|---|
| 29. Highlights the legal and ethical challenges of biomedical data in AI systems; stresses the need for human oversight and dynamic validation of AI; | 29. Highlights the legal and ethical challenges of biomedical data in AI systems; stresses the need for human oversight and dynamic validation of AI, tailored to the specificities of the sector and aligned with existing EU rules, guidance, and frameworks; |
Or. en
Amendment 511
Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová
Motion for a resolution
Paragraph 29 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 29 a. Calls on the Commission to ensure the smooth functioning of the EU Single Market, to work with Member States to prevent regulatory fragmentation, and to ensure that all new regulatory initiatives in life sciences and biotechnology hold legal certainty, as well as timely and predictable regulatory paths to market, as core principles; |
Or. en
Amendment 512
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 29 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 29 a. Demands a correct and full implementation of the Cartagena and Nagoya Protocols and ratification of the WIPO Treaty, calls on Member States to step up their enforcement of those essential agreements, and calls on the Commission to publish a report on the implementation of the protocols in 2026; |
Or. en
Amendment 513
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 29 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 29 a. Stresses the need for civil society involvement on the ethical implications of biotechnology, empowering individuals to make informed decisions about therapeutic adherence, science-based regulation and the importance of using health data in research and technological innovation processes; |
Or. en
Amendment 514
Ignazio Roberto Marino
Motion for a resolution
Paragraph 29 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 29 a. Calls on the Commission to facilitate stronger, practical, and long-term data-sharing agreements with international partners to enable global collaboration in AI-driven research; |
Or. en
Amendment 515
Ignazio Roberto Marino
Motion for a resolution
Paragraph 29 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 29 b. Underlines the urgent need to build public trust in the use of biotechnology in public health by ensuring transparency, access to raw data and clinical trial results, strong ethical oversight, and meaningful public involvement; firmly rejects misinformation that undermines public health and ignores the broad scientific consensus on the safety and effectiveness of biotech innovations, such as vaccines; stresses that trust cannot be achieved through top-down promotion alone, but requires inclusive dialogue, independent scientific review, and clear, evidence-based communication on risks, benefits, and long-term effects; |
Or. en
Amendment 516
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 29 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 29 b. Stresses the importance of developing human capital with expertise in biotechnology, of supporting the cross-border recognition of qualifications and of promoting the uptake of highly specialised scientists and human technical resources in the EU; to foster partnerships between universities, research centres and technology-based start-ups and SMEs to promote biotech entrepreneurship and accelerate innovation capacity in the EU; |
Or. en
Amendment 517
Ignazio Roberto Marino
Motion for a resolution
Paragraph 29 c (new)
| Motion for a resolution | Amendment |
|---|---|
| 29 c. Highlights the importance of assessing the long-term health impacts of biotechnologies used in areas like food and agriculture, engineered microbes, and related technologies; |
Or. en
Amendment 518
Ignazio Roberto Marino
Motion for a resolution
Paragraph 29 d (new)
| Motion for a resolution | Amendment |
|---|---|
| 29 d. Calls for ecosystem impact assessments to be included in the evaluation of biotechnologies, especially in agriculture; emphasises that environmental changes linked to the use of technologies like GMOs may have important long-term consequences for public health; |
Or. en
Amendment 519
Ignazio Roberto Marino
Motion for a resolution
Paragraph 30
| Motion for a resolution | Amendment |
|---|---|
| 30. Stresses that biotechnologies should work alongside other technologies, fostering parallel development to achieve more effective solutions and innovation, in line with a technology-neutral approach; | 30. Stresses that biotechnologies should work alongside other technologies, fostering parallel development to achieve more effective solutions and innovation, in line with a technology-neutral approach; Stresses the need to simplify and align regulatory pathways for clinical research approvals, which are often subject to multiple, disconnected frameworks, each with different timelines, requirements, and systems; notes that key legislative texts (such as the CTR, IVDR, and MDR) are interpreted differently across Member States, resulting in inconsistent implementation and a fragmented regulatory landscape; |
Or. en
Amendment 520
Aurelijus Veryga
Motion for a resolution
Paragraph 30
| Motion for a resolution | Amendment |
|---|---|
| 30. Stresses that biotechnologies should work alongside other technologies, fostering parallel development to achieve more effective solutions and innovation, in line with a technology-neutral approach; | 30. Stresses that biotechnologies should work alongside other technologies, fostering parallel development to achieve more effective solutions and innovation, in line with a technology-neutral approach; stresses the need to simplify and better coordinate clinical approval processes across the EU, in order to reduce unnecessary regulatory complexity and duplication; notes that the current system is fragmented, with divergent timelines, requirements, and interpretations across Member States, which undermines legal certainty and delays innovation; |
Or. en
Amendment 521
Dan-Ştefan Motreanu
Motion for a resolution
Paragraph 30
| Motion for a resolution | Amendment |
|---|---|
| 30. Stresses that biotechnologies should work alongside other technologies, fostering parallel development to achieve more effective solutions and innovation, in line with a technology-neutral approach; | 30. Stresses that biotechnologies should work alongside other technologies, fostering parallel development to achieve more effective solutions and innovation, in line with a technology-neutral approach; Stresses the need to simplify and converge regulatory pathways for clinical approvals which are subject to multiple, often disconnected regulatory pathways, each with distinct timelines, requirements and systems and where the various legislative texts (e.g., CTR vs. MDR/IVDR) are interpreted differently across Member States; |
Or. en
Amendment 522
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 30
| Motion for a resolution | Amendment |
|---|---|
| 30. Stresses that biotechnologies should work alongside other technologies, fostering parallel development to achieve more effective solutions and innovation, in line with a technology-neutral approach; | 30. Stresses that biotechnologies should work alongside other technologies, fostering parallel development to achieve more effective solutions and innovation; |
Or. en
Amendment 523
Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová
Motion for a resolution
Paragraph 30
| Motion for a resolution | Amendment |
|---|---|
| 30. Stresses that biotechnologies should work alongside other technologies, fostering parallel development to achieve more effective solutions and innovation, in line with a technology-neutral approach; | 30. Emphasises that biotechnologies must be developed within a holistic and forward-looking framework, encouraging synergies with digital, AI, and other key technologies; |
Or. en
Amendment 524
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 30 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 30 a. Points out that accountability must be ensured through risk assessment and auditing mechanisms. Whenever possible, these mechanisms should be integrated into the data management models themselves, and reliable third-party certification mechanisms should be implemented. The development of integrated biosecurity applications should be part of biotechnology promotion programs; |
Or. en
Amendment 525
Liesbet Sommen, Sérgio Humberto
Motion for a resolution
Paragraph 30 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 30 a. Urges the Commission to propose, within the framework of the European Biotech Act, a comprehensive and integrated approach covering all key biotechnology sectors, with the aim of fostering innovation and strengthening the competitiveness of the European biotechnology sector; |
Or. en
Amendment 526
Dolors Montserrat, Elena Nevado del Campo
Motion for a resolution
Paragraph 30 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 30 a. Calls for closer alignment between Europe’s industrial, innovation, and health policies to ensure that access pathways keep pace with scientific advances, including through early dialogue between regulators, HTA bodies, and developers; |
Or. en
Amendment 527
Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc
Motion for a resolution
Paragraph 31
| Motion for a resolution | Amendment |
|---|---|
| 31. Calls on the Commission to conduct an impact assessment before the publication of the EU Biotech Act, taking stakeholders’ input into due account; | 31. Calls on the Commission to conduct an impact assessment before the publication of the EU Biotech Act and ensure subsequent monitoring after its publication, to assess the most appropriate solutions to improve public health, meet patient needs, and boost competitiveness, preserving quality and safety standards; calls on the Commission to take stakeholders’ input into due account; |
Or. en
Amendment 528
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 31
| Motion for a resolution | Amendment |
|---|---|
| 31. Calls on the Commission to conduct an impact assessment before the publication of the EU Biotech Act, taking stakeholders’ input into due account; | 31. Calls on the Commission to conduct a comprehensive impact assessment before the publication of the EU Biotech Act, incorporating input from stakeholders across the entire life science ecosystem and throughout the life cycle of technologies and products; |
Or. en
Amendment 529
Stine Bosse, Billy Kelleher
Motion for a resolution
Paragraph 31 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 31 a. Stresses the need for the Commission to enforce the cross-border healthcare directive and to support Member States in applying the provisions of the directive to advanced cell and gene therapies (ATMPs) in order to boost patient access; recognises that patients in most Member States do not have access to specialised treatment centres in their own countries, and that the most cost-effective approach is for the entirety of the EU to rely on a few such centres; calls on the Commission to issue guidance to national authorities on specialised reimbursement pathways that would enable access to life-saving treatments to as many Europeans as possible; |
Or. en
Amendment 530
Dolors Montserrat, Elena Nevado del Campo
Motion for a resolution
Paragraph 31 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 31 a. Calls on the Commission to support the creation of a dedicated EU matchmaking platform to connect translation-ready academic research with investors, manufacturing infrastructures, and experienced developers, with the aim of accelerating the clinical development and commercialisation of promising biotechnology discoveries; |
Or. en
Amendment 531
Elena Nevado del Campo, Dolors Montserrat
Motion for a resolution
Paragraph 31 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 31 a. Calls on the Commission to include a clear and operational definition of biotechnology in the upcoming Biotech Act, to provide clarity for regulators, industry, and researchers; |
Or. en
Amendment 532
Stine Bosse, Billy Kelleher
Motion for a resolution
Paragraph 31 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 31 b. Encourages the Commission to make use of voluntary joint public procurement to pilot voluntary EU-level coordination for the procurement of medical products and ATMPs targeting ultra-rare conditions, where national access may currently be constrained by limited patient cohorts; |
Or. en
Amendment 533
Stine Bosse, Billy Kelleher
Motion for a resolution
Paragraph 31 c (new)
| Motion for a resolution | Amendment |
|---|---|
| 31 c. Calls for the revision of the Cross-border Healthcare Directive to ensure greater patient access to treatment, in particular as regards orphan drugs and advanced therapies (ATMPs), across borders with a single set of authorisation rules and a single appeal system for rejects that may be unwarranted; |
Or. en
Amendment 534
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 32
| Motion for a resolution | Amendment |
|---|---|
| 32. Calls on the Commission to support the Member States in launching attractive programmes for health-related biotechnology companies, such as industrial parks that offer a collaborative environment for development; | 32. Calls for the implementation of national biotechnology strategies to integrate into their national health systems a plan for updating and developing biotechnology within the healthcare system, as well as recommendations for developing their research networks and integrating them into the European data space; |
Or. en
Amendment 535
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 32
| Motion for a resolution | Amendment |
|---|---|
| 32. Calls on the Commission to support the Member States in launching attractive programmes for health-related biotechnology companies, such as industrial parks that offer a collaborative environment for development; | 32. Calls on the Commission to support Member States in launching attractive programmes for health-related biotechnology companies, such as technology transfer offices at universities and research centres, incubators and industrial parks that offer a collaborative environment for development; |
Or. en
Amendment 536
Dolors Montserrat, Elena Nevado del Campo
Motion for a resolution
Paragraph 32
| Motion for a resolution | Amendment |
|---|---|
| 32. Calls on the Commission to support the Member States in launching attractive programmes for health-related biotechnology companies, such as industrial parks that offer a collaborative environment for development; | 32. Calls on the Commission to support the Member States in launching attractive programmes for health-related biotechnology companies that offer a collaborative environment for development, such as ecosystem hubs, innovation campuses or industrial parks; |
Or. en
Amendment 537
Ignazio Roberto Marino
Motion for a resolution
Paragraph 32 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 32 a. Encourages the integration of environmental and ethical impact assessments in biotech development strategies, ensuring alignment with the Union's sustainability goals; |
Or. en
Amendment 538
Anja Hazekamp, Catarina Martins, Sebastian Everding
Motion for a resolution
Paragraph 33
| Motion for a resolution | Amendment |
|---|---|
| 33. Urges the Commission to promote the acceleration of permitting and licensing processes across the EU for biotechnology-related activities; | deleted |
Or. en
Amendment 539
Ignazio Roberto Marino
Motion for a resolution
Paragraph 33
| Motion for a resolution | Amendment |
|---|---|
| 33. Urges the Commission to promote the acceleration of permitting and licensing processes across the EU for biotechnology-related activities; | 33. Invites the Commission to asses the need of promote the acceleration of permitting and licensing processes across the EU for biotechnology-related activities; |
| urges the Commission to accelerate clinical trial approval timelines to help Europe stay competitive and ensure that European patients can take part in global multi-country trials; stresses that any efforts to streamline procedures must not compromise public health, environmental safety, or the long-term monitoring of potential adverse effects; highlights the need for caution when dealing with new biotechnologies whose long-term health impacts are not yet fully known; |
Or. en
Amendment 540
Dolors Montserrat, Elena Nevado del Campo
Motion for a resolution
Paragraph 33
| Motion for a resolution | Amendment |
|---|---|
| 33. Urges the Commission to promote the acceleration of permitting and licensing processes across the EU for biotechnology-related activities; | 33. Urges the Commission to promote the acceleration of permitting and licensing processes across the EU for biotechnology-related activities; urges the Commission to promote the acceleration of Clinical Trial Assessment approval timelines to allow Europe to be more competitive and allow European patients to participate in global multi-country trials; |
Or. en
Amendment 541
Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc
Motion for a resolution
Paragraph 33
| Motion for a resolution | Amendment |
|---|---|
| 33. Urges the Commission to promote the acceleration of permitting and licensing processes across the EU for biotechnology-related activities; | 33. Urges the Commission to promote the acceleration of permitting and licensing processes across the EU for biotechnology-related activities; calls for collaboration with Member States to establish clear, efficient, and predictable regulatory timelines, especially for projects with low risk or strategic relevance; |
Or. en
Amendment 542
Stine Bosse, Billy Kelleher
Motion for a resolution
Paragraph 33
| Motion for a resolution | Amendment |
|---|---|
| 33. Urges the Commission to promote the acceleration of permitting and licensing processes across the EU for biotechnology-related activities; | 33. Urges the Commission to promote the acceleration of permitting and licensing processes across the EU for biotechnology-related activities while continuing to ensure a high standard of environmental sustainability and to support the strong EU record on environmental protection and sustainable water management; |
Or. en
Amendment 543
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 33
| Motion for a resolution | Amendment |
|---|---|
| 33. Urges the Commission to promote the acceleration of permitting and licensing processes across the EU for biotechnology-related activities; | 33. Urges the Commission to promote the acceleration of authorisation and licensing processes across the EU for biotechnology-related activities also by promoting regulatory coherence and harmonisation; |
Or. en
Amendment 544
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 33 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 33 a. Calls on the Commission to promote the implementation of the Clinical Trials Regulation through projects that empower and streamline the conduct of multi-country trials in the EU, making it a more competitive region, including for the development of advanced therapies and personalised medicine; |
Or. en
Amendment 545
Margarita de la Pisa Carrión
Motion for a resolution
Paragraph 33 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 33 a. Urges the Commission to promote the acceleration of Clinical Trial Assessment approval timelines to allow Europe to compete and allow European patients to participate in global multi-country trials; |
Or. en
Amendment 546
Ignazio Roberto Marino
Motion for a resolution
Paragraph 34
| Motion for a resolution | Amendment |
|---|---|
| 34. Highlights that institutions should act as enablers of health-related biotechnology innovation; | 34. Highlights that institutions should act as enablers of health-related biotechnology innovation; emphasises that institutions should act as enablers of health-related biotechnology innovation, while ensuring it serves the public interest, upholds the highest standards of safety and ethics, and applies the precautionary principle where appropriate; underlines the importance of democratic governance, independent oversight, and public participation in guiding the development and use of biotechnologies in healthcare; |
Or. en
Amendment 547
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin
Motion for a resolution
Paragraph 34
| Motion for a resolution | Amendment |
|---|---|
| 34. Highlights that institutions should act as enablers of health-related biotechnology innovation; | 34. Highlights that institutions must act as support elements for health-related biotechnological innovation, including off-patent-led advances in technology, manufacturing, and medicinal products, promoting at the sime time the integration of innovations into their healthcare services so that patients can truly benefit from improvements in their health; |
Or. en
Amendment 548
Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc
Motion for a resolution
Paragraph 34
| Motion for a resolution | Amendment |
|---|---|
| 34. Highlights that institutions should act as enablers of health-related biotechnology innovation; | 34. Highlights that institutions, as part of their public service mission, should act as enablers of health-related biotechnology innovation, supporting projects, offering expert guidance, simplifying procedures, and fostering an environment where SMEs can thrive and scale up within the EU; |
Or. en
Amendment 549
Dolors Montserrat, Elena Nevado del Campo
Motion for a resolution
Paragraph 34
| Motion for a resolution | Amendment |
|---|---|
| 34. Highlights that institutions should act as enablers of health-related biotechnology innovation; | 34. Highlights that institutions should act as enablers of health-related biotechnology innovation, including off-patent-led innovation on technology, manufacturing, and medicinal products; |
Or. en
Amendment 550
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 34 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 34 a. Emphasizes that biotechnology must be accessible to all citizens of the European Union, regardless of their place of residence, socioeconomic status, or other factors that may limit their access to health services. This entails the need to enhance ERNs and establish cross-border healthcare that is swift, simplified, and efficient, especially for innovative therapies which, due to their nature, limited number of beneficiary patients, cost, or access conditions, cannot be provided in all Member States; |
Or. en
Amendment 551
Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová
Motion for a resolution
Paragraph 34 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 34 a. Underlines the strategic importance of the upcoming negotiations on the Multiannual Financial Framework; calls for an ambitious budget that allocates sufficient resources to research, health, and innovation, enabling Europe to remain globally competitive while addressing societal challenges through cutting-edge science; |
Or. en
Amendment 552
Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová
Motion for a resolution
Paragraph 35
| Motion for a resolution | Amendment |
|---|---|
| 35. Calls on the Commission to consider the financial needs of the biotechnology sector to foster a coherent, efficient and flexible financial framework that creates opportunities; | 35. Calls for the establishment of a coherent and flexible EU financing strategy adapted to the specific needs of the biotechnology sector; highlights the importance of fully mobilising existing instruments such as Horizon Europe, InvestEU and STEP to support biotech innovation; underlines the need to reduce financial risks at early stages and to attract more private investment in the development and scale-up of innovative biotechnology solutions; |
Or. en
Amendment 553
Adam Jarubas, Ewa Kopacz, Bartosz Arłukowicz
Motion for a resolution
Paragraph 35
| Motion for a resolution | Amendment |
|---|---|
| 35. Calls on the Commission to consider the financial needs of the biotechnology sector to foster a coherent, efficient and flexible financial framework that creates opportunities; | 35. Calls on the Commission to consider the financial needs of the biotechnology sector to foster a coherent, efficient and flexible financial framework that creates opportunities and financial stability for biomanufacturing companies operating in Europe and ensuring the continuous supply of essential medicines to European patients; |
Or. en
Amendment 554
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 35
| Motion for a resolution | Amendment |
|---|---|
| 35. Calls on the Commission to consider the financial needs of the biotechnology sector to foster a coherent, efficient and flexible financial framework that creates opportunities; | 35. Calls on the Commission to consider the financial needs of the biotechnology sector to promote a coherent, efficient and flexible financial framework that creates opportunities, including facilitated access to European-level funding for science and innovation and a European strategy for biotechnology-focused venture capital; |
Or. en
Amendment 555
Waldemar Buda
Motion for a resolution
Paragraph 35 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 35 a. Calls for the establishment of dedicated support mechanisms for biotechnology and biomanufacturing companies, especially those producing critical medicines; |
Or. en
Amendment 556
Aurelijus Veryga
Motion for a resolution
Paragraph 35 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 35 b. Calls on the creation of an EU Biotech Innovation Fund to support researchers, academia, start-ups and SMEs conducting R&D and innovation in healthcare biotechnologies; |
Or. en
Amendment 557
Liesbet Sommen, Sérgio Humberto
Motion for a resolution
Paragraph 36
| Motion for a resolution | Amendment |
|---|---|
| 36. Call for a broad and forward-looking approach to the various needs of the biotech health sector that addresses potential challenges related to the supply and cost of raw materials, equipment and components; | 36. Call for a broad and forward-looking approach to the various needs of the biotech health sector that not only adresses potential challenges related to the supply and cost of raw materials, equipment and components, but also pays due attention to emerging threats such as antimicrobial resistance (AMR), co-infections in viral and respiratory diseases during health crises and pandemics, as well as structurally underfunded areas such as long COVID and rare diseases within the EU; |
Or. en
Amendment 558
Margarita de la Pisa Carrión, Ondřej Knotek, Viktória Ferenc
Motion for a resolution
Paragraph 36
| Motion for a resolution | Amendment |
|---|---|
| 36. Call for a broad and forward-looking approach to the various needs of the biotech health sector that addresses potential challenges related to the supply and cost of raw materials, equipment and components; | 36. Call for a broad and forward-looking approach to the various needs of the biotech health sector that addresses potential challenges related to the supply and cost of raw materials, consumables, equipment and components; calls on the Commission to promote measures ensuring secure and affordable access to energy for biotech operators, including the support of cost-effective energy solutions; |
Or. en
Amendment 559
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 36
| Motion for a resolution | Amendment |
|---|---|
| 36. Call for a broad and forward-looking approach to the various needs of the biotech health sector that addresses potential challenges related to the supply and cost of raw materials, equipment and components; | 36. Calls for the diverse needs of the medical biotechnology sector to be addressed from a broad and forward-looking approach that tackles potential challenges related to supply, dependence on third countries for critical technologies, and the cost of raw materials, equipment, and components, within the framework of the Union’s overall supply and foreign trade strategy; |
Or. en
Amendment 560
Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová
Motion for a resolution
Paragraph 36
| Motion for a resolution | Amendment |
|---|---|
| 36. Call for a broad and forward-looking approach to the various needs of the biotech health sector that addresses potential challenges related to the supply and cost of raw materials, equipment and components; | 36. Stresses the importance of addressing operational and supply chain challenges, including access to raw materials, components, critical equipment and skilled workforce, through coordinated EU action, fostering a resilient and innovation-driven environment for biotech companies; |
Or. en
Amendment 561
Liesbet Sommen, Sérgio Humberto
Motion for a resolution
Paragraph 36 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 36 a. Urges the Commission to explicitly address the upskilling and reskilling of the workforce in the context of the European Biotech Act, as skills and labour shortages hamper Europe’s competitiveness, including in the biotechnology sector; also calls for the strengthening of the quality of education, training and lifelong learning, inspired by the ‘Union of Skills’ initiative, in order to ensure the development of highly qualified talent in the biotechnology sector; |
Or. en
Amendment 562
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 36 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 36 a. Recognizes that while AI systems and computing can significantly accelerate research and lead to new innovations—enabling better computational designs of biological systems and faster methods to design DNA and genomes of organisms—they can also lower the barrier to biological threats; therefore, calls for a robust governance framework to address these threats; |
Or. en
Amendment 563
Liesbet Sommen, Sérgio Humberto
Motion for a resolution
Paragraph 36 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 36 b. Stresses the importance for Member States to update their national action plans on rare diseases, in cooperation with the European Commission, academic institutions, and relevant stakeholders from the biotech sector; emphasises that the drafting of these plans should be aligned with best practices exchanged among Member States and encourages that these be discussed within the Commission’s expert groups; |
Or. en
Amendment 564
Olivier Chastel, Billy Kelleher, Stine Bosse, Veronika Cifrová Ostrihoňová
Motion for a resolution
Paragraph 37
| Motion for a resolution | Amendment |
|---|---|
| 37. Calls for a European-wide, dynamic matchmaking platform that connects technology readiness level-mature research, funding bodies, incubators and investors with shared analytics and performance indicators; | 37. Calls for a European-wide, dynamic matchmaking platform for biotechnology and life sciences that connects technology readiness level-mature research, funding bodies, legal and scientific advice, incubators and investors; suggests that the platform integrate shared performance data, patient-centred impact indicators and investment-readiness metrics to facilitate the translation of innovation into accessible solutions; |
Or. en
Amendment 565
Stine Bosse, Billy Kelleher
Motion for a resolution
Paragraph 37 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 37 a. Calls for the Biotech Act to initiate a comprehensive review of barriers to the adoption of medical innovation in the EU across borders, including the role of the EU and the Member States public health systems and encompassing i.a. screening and diagnosis, digital health records and the use of AI across the public health sector, and European Health Data Space (EHDS) funding and implementation; is convinced in this regard that the Single Market and greater patient access is a fundamental driver of market-creation and research and innovation for biotechnology in the EU; |
Or. en
Amendment 566
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 37 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 37 a. Requests the Commission’s assistance in the effort to harmonize health data to enable their combined use for research purposes; |
Or. en
Amendment 567
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 37 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 37 a. Social implications in biotechnology and life sciences; |
Or. en
Amendment 568
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 37 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 37 b. Reminds that health data are especially sensitive and fundamentally belong to the citizens, and their sharing is done in the interest of a higher public good; |
Or. en
Amendment 569
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 37 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 37 b. Life sciences and biotechnology should continue to focus on societal dialogue, mobilising public debate and citizen participation; |
Or. en
Amendment 570
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
Motion for a resolution
Paragraph 37 c (new)
| Motion for a resolution | Amendment |
|---|---|
| 37 c. Requests that the system architecture directs competition among companies towards developing better data exploitation tools, rather than competing to obtain health data themselves, and that the status of health data should be as close as possible to that of a public good; |
Or. en
Amendment 571
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 37 c (new)
| Motion for a resolution | Amendment |
|---|---|
| 37 c. Underlines the need to ensure that scientific and technological advances in biotechnology and science are used in an ethical, safe, inclusive and socially beneficial manner; |
Or. en
Amendment 572
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 37 d (new)
| Motion for a resolution | Amendment |
|---|---|
| 37 d. Underlines the need to ensure fair and equitable access by promoting the democratisation of access to health technologies (e.g. vaccines, gene therapies and advanced diagnostics) as well as technology transfer to developing countries; |
Or. en
Amendment 573
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 37 e (new)
| Motion for a resolution | Amendment |
|---|---|
| 37 e. Underlines the use of all existing and well-articulated public, private and social means to ensure the quality of the health response for all citizens; |
Or. en
Amendment 574
Sérgio Humberto, Liesbet Sommen
Motion for a resolution
Paragraph 37 f (new)
| Motion for a resolution | Amendment |
|---|---|
| 37 f. In healthcare, the need for new and innovative approaches to address demographic challenges such as population ageing and longevity is an emergency; |
Or. en
Amendment 575
Stine Bosse, Billy Kelleher
Motion for a resolution
Paragraph 38 – subparagraph 1 (new)
| Motion for a resolution | Amendment |
|---|---|
| Ensuring a simplified and future-proof regulatory environment for European Biotech; |
Or. en
Amendment 576
Stine Bosse, Billy Kelleher
Motion for a resolution
Paragraph 38 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 38 a. Highlights the de-funding and staff reductions at the Food and Drug Administration (FDA) in the United States that undermine its role as the leading global medicines regulator, and which are likely to degrade EU patient access to innovative medicines and undermines global access to vaccines; underlines in this regard the urgent need to ensure that the European Medicines Agency (EMA) becomes the world-leading medicines regulator; |
Or. en
Amendment 577
Stine Bosse, Billy Kelleher
Motion for a resolution
Paragraph 38 b (new)
| Motion for a resolution | Amendment |
|---|---|
| 38 b. Stresses the urgent need to strengthen the capacity and resourcing of the EU regulatory network for medicines, namely the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) to ensure the timely and efficient evaluation of innovative therapies and to ensure that the EU is seen as the most attractive region globally to launch new medical products; |
Or. en
Amendment 578
Stine Bosse, Billy Kelleher
Motion for a resolution
Paragraph 38 c (new)
| Motion for a resolution | Amendment |
|---|---|
| 38 c. Stresses that appropriate funding and in-house expertise for the EMA and HMA is fundamental both for the development of new vaccines and novel antimicrobials as well as for EU preparedness for health emergencies including viral threats and anti-microbial resistance (AMR); underlines that the EMA should be appropriately resourced as to proactively provide scientific advice and provide clarity on the regulatory path to market and time to market to innovative biotech companies, including SMEs and developers of novel antimicrobials; |
Or. en
Amendment 579
Stine Bosse, Billy Kelleher
Motion for a resolution
Paragraph 38 d (new)
| Motion for a resolution | Amendment |
|---|---|
| 38 d. Recalls the ongoing backlog of Good Manufacturing Practice (GMP) inspections due to the COVID-19 pandemic which must be urgently addressed, whereas the mutual recognition agreement with non-EU regulators such as the U.S. Food and Drug Administration (FDA) are important to resolve this backlog; underlines that the EU inspections backlog now risks growing given the latest U.S. administration decisions to defund the FDA and to prioritise GMP inspections in the U.S.; stresses in this regard EU vulnerability in its ability to inspect manufacturing facilities, which is a major challenge to increasing biotech manufacturing capacity and therefore EU competitiveness and strategic autonomy in public health; calls in this regard for the conclusion of additional mutual recognition agreements with like-minded partner countries; |
Or. en
Amendment 580
Stine Bosse, Billy Kelleher
Motion for a resolution
Paragraph 38 e (new)
| Motion for a resolution | Amendment |
|---|---|
| 38 e. Stresses the need to urgently restore close collaboration between the European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency (MHRA) in order to strengthen innovation in biotech and life sciences in all of Europe, including but not limited to the EU; |
Or. en
Amendment 581
Stine Bosse, Billy Kelleher
Motion for a resolution
Paragraph 38 f (new)
| Motion for a resolution | Amendment |
|---|---|
| 38 f. Highlights that, the absence of a superstructure and co-location for key agencies and regulators including the EMA, the ECDC, DG SANTE and DG HERA, a Life Sciences and Biotechnology Office should be established as part of the European Commission in order to co-ordinate all relevant horizontal policies and work to ensure that the EU is seen as the best place in the world to invest in life sciences and biotechnology R&D, manufacturing and clinical trials; |
Or. en