What changed between the draft committee report and the plenary report

MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION

on public health aspects of biotechnology and life sciences

(2025/2087(INI))

The European Parliament,

Changed:– having regard to the Treaty on the Functioning of the European Union, in particular Articles 9, 151, 168,6, 1738 and 17921 thereof,

Changed:– having regard to the Treaty on Europeanthe Union,Functioning inof particularthe ArticleEuropean 5(3)Union, thereofin andparticular ProtocolArticles No4, 25, thereto6, on9, the114, application151, of153, the168, principles169, of173, subsidiarity179 and proportionality,191 thereof,

Removed:– 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,

Added:– 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 to Articles 3, 8 and 35 thereof,

Removed:– 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) 2021/241,

Added:– having regard to the European Convention on Human Rights,

Added:– 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,

Added:– having regard to the Additional Protocol to the Convention on Human Rights and Biomedicine on the Prohibition of Cloning Human Beings (CETS No 168),

Added:– having regard to the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research (CETS No 195),

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

Added:– having regard to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (Cross-Border Healthcare Directive),

Added:– 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 (the Clinical Trials Regulation),

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

– having regard to Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU,

Removed:– having regard to the Commission communication of 20 March 2024 entitled ‘Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU’ (COM(2024)0137),

Added:– 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,

Removed:– having regard to the Commission communication of 3 February 2021 entitled ‘Europe’s Beating Cancer Plan’ (COM(2021)0044),

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

Changed:– having regard to the Commission Recommendationproposal (EU)of 2023/211326 April 2023 for a directive of 3the OctoberEuropean 2023Parliament onand criticalof technologythe areasCouncil foron the EU’sUnion economiccode securityrelating to medicinal products for furtherhuman riskuse, assessmentand withrepealing MemberDirective States,2001/83/EC and Directive 2009/35/EC (COM(2023)0192),

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

Added:– having regard to the Commission proposal of 26 April 2023 for a 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 (COM(2023)0193),

Changed:– having regard to theits Commissionresolution Annualof Report1 onJune European2023 SMEson 2023/2024EU ofaction 4to Julycombat 2024,antimicrobial resistance,

– having regard to the Universal Declaration on the Human Genome and Human Rights, adopted by UNESCO on 11 November 1997,

Removed:– having regard to the 2025 concluding remarks on the European Union of the UN Committee on the Rights of Persons with Disabilities,

Added:– 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),

Added:– having regard to the report by Mario Draghi of 9 September 2024 entitled ‘The future of European competitiveness’,

Added:– having regard to the report by Enrico Letta of 17 April 2024 entitled ‘Much More Than a Market’,

Added:– having regard to the report by Sauli Niinistö of 30 October 2024 entitled ‘Safer Together – Strengthening Europe’s Civilian and Military Preparedness and Readiness’,

Added:– having regard to the report by the Panel for the Future of Science and Technology (STOA) entitled ‘Improving access to medicines and promoting pharmaceutical innovation’, published in November 2023,

Added:– having regard to the Commission communication of 28 May 2025 entitled ‘The EU Startup and Scaleup Strategy – Choose Europe to start and scale’ (COM(2025)0270),

Added:– having regard to the 1948 Universal Declaration of Human Rights,

Added:– having regard to the 2003 UNESCO International Declaration on Human Genetic Data,

Added:– having regard to the 2005 UNESCO Universal Declaration on Bioethics and Human Rights,

Added:– having regard to the report to the UN Human Rights Council by the former Special Rapporteur in the field of Cultural Rights, Farida Shaheed, on the right to enjoy the benefits of scientific progress and its applications (A/HRC/20/26), published on 14 May 2012,

Added:– having regard to the report to the UN Human Rights Council by the Special Rapporteur in the field of Cultural Rights, Alexandra Xanthaki, on the right to participate in science (A/HRC/55/44), published on 21 February 2024,

Added:– having regard to the World Health Organization 2024 guidelines on addressing key gender inequalities in national action plans on antimicrobial resistance,

Added:– 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’,

Added:– having regard to the 2025 concluding observations on the combined 2nd and 3rd periodic reports of the European Union by the UN Committee on the Rights of Persons with Disabilities,

Added:– 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),

– having regard to Rule 55 of its Rules of Procedure,

Changed:– having regard to the report of the Committee on Public Health (A100000/2025),(A10-0274/2025),

Change 1

Removed: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;

Added:A. whereas the Organisation for Economic Co-operation and Development 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’, aimed at improving human health;

Removed:B. whereas the sequencing of the DNA structure marked a pivotal moment in understanding human genetics and accelerating biotechnology development;

Added:B. whereas advanced therapy medicinal products (ATMPs) represent a strategic frontier in biotechnology, with the potential to address high unmet medical needs, redefine the treatment of severe and rare diseases, markedly enhance patient outcomes and alleviate burdens on healthcare systems;

Removed:C. whereas biotechnology has been identified as a critical technology area for the EU;

Added:C. 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 limited support for technology transfer and manufacturing scale-up;

Removed: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;

Added:D. whereas the sequencing of the human genome, along with the manipulation of stem cells and the emergence of gene editing mechanisms, among other innovations, have transformed the capacity to understand human biology and accelerated the development of new fields of innovation to improve health;

Removed:E. whereas deepening our knowledge of life sciences can drive innovation in biotechnology, particularly in the pharmaceutical industry;

Added:E. 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 shown during the COVID-19 pandemic; whereas these biotech-driven innovations not only exemplify the swift translation of advanced research into life-saving solutions with high societal impact, but are also essential to advancing a prevention-focused healthcare model, centred on early intervention, screening, preparedness and broad immunisation strategies;

Removed:F. whereas the EU leads in scientific publications in biotechnology, but struggles to turn research into market solutions;

Added:F. whereas biotechnology contributes significantly to better preparedness and response, applying the One Health approach to 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 (AMR) and unexpected emergencies;

Removed: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;

Added:G. whereas biotechnology should help to cover the full spectrum of natural risks and threats, promoting coordination and efficiency and fostering capacity building and cooperation among Member States;

Removed:H. whereas small and medium-sized enterprises (SMEs) represent over 99 % of EU businesses and constitute the majority in the biotechnology field;