Text · Amendment list
Public health aspects of biotechnology and life sciences
Document SANT-AM-774459 · 2025/2087(INI)
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- Amendment list SANT-AM-774459
- Date
- 17 June 2025
- Committee
- Committee on Public Health
- Dossier
- 2025-2087
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- 2025/2087(INI)
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| Motion for a resolution | Amendment |
|---|---|
| – 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, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the European Convention for the Protection of Human Rights and Fundamental Freedoms, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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), |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (CETS No. 195), |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes (CETS No. 203), |
| Motion for a resolution | Amendment |
|---|---|
| – 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. |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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. |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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), |
| Motion for a resolution | Amendment |
|---|---|
| – 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. |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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), |
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou
| Motion for a resolution | Amendment |
|---|---|
| – 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), |
| Motion for a resolution | Amendment |
|---|---|
| – 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), |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the European Parliaments motion for resolution on EU action to combat antimicrobial resistance (2023/2703(RSP)), |
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the Commission communication of 11 December 2019 entitled ‘The European Green Deal’ (COM(2019)640), |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin
| Motion for a resolution | Amendment |
|---|---|
| – 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), |
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, adopted on 29 January 2000, |
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, adopted on 24 May 2024, |
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the Commission communication of 29 January 2025 entitled ‘A Competitiveness Compass for the EU’ (COM(2025)0030), | deleted |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the report "The Future of European Competitiveness" by Mario Draghi, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the report "Much More Than a Market" by Enrico Letta, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the report "Stronger together" on strengthening EU civil and military preparedness and readiness by Sauli Niinistö, |
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the Commission Annual Report on European SMEs 2023/2024 of 4 July 2024, | deleted |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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), |
| Motion for a resolution | Amendment |
|---|---|
| – 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), |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the 1997 UNESCO Universal Declaration on the Human Genome and Human Rights, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the 2003 UNESCO International Declaration on Human Genetic Data, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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), |
| Motion for a resolution | Amendment |
|---|---|
| – having regard to availability, resilience of supply chains of essential and critical medicines, strategic autonomy, the Draghi Report and the Critical Medicines Act, |
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the Rathenau Institute's 2020 publication 'Data solidarity for health - Points for improvement with an eye on everyone's interests', |
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the WHO guidelines on addressing key gender inequalities in the prevention, diagnosis and treatment of drug-resistant infections, |
| Motion for a resolution | Amendment |
|---|---|
| – 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", |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – 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), |
| Motion for a resolution | Amendment |
|---|---|
| – 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', |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the 2025 concluding observations on the European Union by the United Nations Committee on the Rights of Persons with Disabilities, |
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
| Motion for a resolution | Amendment |
|---|---|
| – 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, |
| Motion for a resolution | Amendment |
|---|---|
| – having regard to the Draghi report on “the Future of European Competitiveness", |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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”; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| D a. whereas improving equitable access to these treatments is essential to ensure that all patients can benefit from biotechnological advances; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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 |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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 |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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). |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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. |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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. |
| Motion for a resolution | Amendment |
|---|---|
| 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. |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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. |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| G a. whereas a clear, coherent and efficient regulatory framework is essential to bolster the biotechnology sector in the EU; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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. |
| Motion for a resolution | Amendment |
|---|---|
| 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. |
| Motion for a resolution | Amendment |
|---|---|
| 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. |
| Motion for a resolution | Amendment |
|---|---|
| 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. |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou
| Motion for a resolution | Amendment |
|---|---|
| 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. |
| Motion for a resolution | Amendment |
|---|---|
| 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 |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| J a. whereas it is crucial that EU continues to stay competitive globally in attracting and promoting investment and innovation in biotech and biomanifacturing; |
| Motion for a resolution | Amendment |
|---|---|
| J a. whereas the EU’s share in global clinical trials has declined from 22 % in 2013 to 12 % in 2023; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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 |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 1 b. Encourages the development and validation of fit for purpose new approach methodologies (NAMs) for the safety assessment of emerging biotechnologies; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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"; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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. |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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: |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 6 a. Calls for the application of the One Health approach in biotechnology, promoting more sustainable development of new medicines and vaccines; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 6 a. Emphasizes the importance of genetic surveillance of pathogens and the rapid design of vaccines in epidemiological control and public health; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 6 b. Emphasises biotechnology’s growing role in forensics, enhancing autopsy precision through techniques like toxicogenomics and microbiome analysis; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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); |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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 ; |
| Motion for a resolution | Amendment |
|---|---|
| 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); |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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 |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 8 a. Calls on the Commission to assess existing regulatory fragmentations in the biotechnology field; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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 |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 9 a. Calls for the Biotech Act to present a common, simplified and harmonised clinical trials framework that allows innovation adoption in clinical research; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 10 a. Supports the development and validation of suitable new approach methodologies (NAMs) for the safety assessment of emerging biotechnologies; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 11 a. Stresses the need for increased research to map and investigate the risks of biotechnology for health and the environment; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 12 a. Emphasizes the need to close the gap between preclinical research and clinical development as a key factor for integrating the university environment; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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. |
| Motion for a resolution | Amendment |
|---|---|
| 13 a. Underlines that the genetic information contained in humans and all other living organisms is a public good, and should not be patented; |
| Motion for a resolution | Amendment |
|---|---|
| 13 a. Emphasizes the importance of strong intellectual property protection for promoting innovation in the EU; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 14. Underlines the need for increased public and private investment in biotechnology, especially in early-stage development; | deleted |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 14 a. Stresses the need for sustained public-private investment in research infrastructures such as biobanks, databases and cell-culture laboratories; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Nikos Papandreou, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 19 a. Highlights the need to strengthen European programmes that promote women leadership in biotechnology, as well as the consolidation of intergenerational mentoring networks; |
| Motion for a resolution | Amendment |
|---|---|
| Unlocking the full potential of the EU clinical trials framework; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| Support for biotech SMEs | Support for biotech start-ups & SMEs |
| Motion for a resolution | Amendment |
|---|---|
| Support for biotech SMEs | Support for biotech SMEs and start-ups |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Kristian Vigenin, Tiemo Wölken
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| Motion for a resolution | Amendment |
|---|---|
| 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; |
| 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; | deleted |
| 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; | deleted |
| 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 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; |
| 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 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; |
| 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; 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; |
| 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 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; |
Nicolás González Casares, Leire Pajín, Romana Jerković, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Tiemo Wölken, Kristian Vigenin, Nikos Papandreou
| 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. 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; |
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- Licensed CC BY 4.0.
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- 25 September 2026
Cite as
European Parliament (2025). “AMENDMENTS 1 - 445 - Draft report Public health aspects of biotechnology and life sciences”. Text, 17 June 2025. docId SANT-AM-774459. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/SANT-AM-774459 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/SANT-AM-774459 (CC BY 4.0).
BibTeX
@misc{epw-text-sant-am-774459,
author = {{European Parliament}},
title = {{AMENDMENTS 1 - 445 - Draft report Public health aspects of biotechnology and life sciences}},
year = {2025},
date = {2025-06-17},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/SANT-AM-774459}},
url = {https://news.eu-parl.st-solutions.dev/texts/SANT-AM-774459},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId SANT-AM-774459. Data: EP Open Data API: document record (CC BY 4.0)}
}