Biotech Act

128 submissions in the snapshot (118 from organisations), portal total 128. Feedback list on the portal.

118 of 118 organisation submissions analysed; the model reads them as: supports 16 wants changes 90 12 held back for review (low confidence).

• European Society for Medical Oncology (ESMO) NGO, CHE; register: Trade unions and professional associations model reads as: wants changes source
  • Explicitly incorporate lessons learned from the Clinical Trials Regulation and IVDR into the Biotech Act, ensuring meaningful EU-level coordination, proportionate requirements, and safeguards against additional procedural layers.

    ESMO therefore considers that the Biotech Act should explicitly incorporate the lessons learned from the CTR and IVDR. In particular, the final Regulation should ensure meaningful EU-level coordination, proportionate and risk-based requirements, greater predictability for sponsors and investigators, and safeguards against the introduction of additional procedural layers across Member States.

  • Accompany regulatory simplification with a coherent and sufficiently ambitious funding framework for health innovation, with dedicated financial envelope for oncology research and ATMP development.

    ESMO also stresses that regulatory simplification must be accompanied by a coherent and sufficiently ambitious funding framework. In the negotiations on the next Multiannual Financial Framework and the proposed European Competitiveness Fund, it will be essential to safeguard a dedicated financial envelope reserved for health innovation, preserving continuity with EU4Health and supporting oncology research, clinical trial infrastructure, regulatory capacity-building, digital health, data governance and ATMP development.

  • Design biotechnology innovation incentives to preserve affordability and timely patient access, particularly where public funding or EU-supported research has contributed to product development.

    Finally, ESMO emphasises that incentives for biotechnology innovation should be designed in a manner that preserves affordability and timely patient access, particularly where public funding or EU-supported research infrastructure has contributed to product development.

• Axel'One Academic or research institution, FRA model reads as: supports source
  • Provide adequate funding for biotechnology development, scale-up and demonstration projects.

    We strongly believe that it is important to support innovation in biotechnology, with adequate funding for development, scale-up and demonstration projects.

  • Utilize existing infrastructures and skills from networks like Pilots4U and IBISBA to avoid redundant investments and accelerate commercialization.

    We also think that utilizing the existing infrastructures and skills, e.g. those listed in the Pilots4U network or in IBISBA, is important to avoid redundant investments and accelerate commercialization.

  • Integrate advanced technologies like online analysis, sensors, big data, and AI to optimize bioprocesses.

    It seems also important to us to integrate advanced technologies like online analysis, sensors, big data, and AI to optimize bioprocesses.

• Empowered By Us Other, NLD; register: Self-employed individuals model reads as: wants changes source
  • Strategic project recognition criteria should explicitly require early and structured engagement with affected communities and relevant civil society actors.

    designation criteria should explicitly require early and structured engagement with affected communities and relevant civil society actors where appropriate.

  • Funding assessment criteria for investment mechanisms should incorporate explicit consideration of unmet health needs, system readiness, and outcomes beyond clinical efficacy.

    To maximise public return on investment, funding assessment criteria should incorporate explicit consideration of: - Unmet or non-lucrative health needs - Real-world system readiness - Outcome dimensions beyond clinical efficacy, including quality of life and functional impact

  • Clarify that patient organisations and affected communities may participate in regulatory sandboxes to strengthen legitimacy and performance.

    Clarifying that patient organisations and affected communities may participate, where relevant, would strengthen both legitimacy and performance.

• DIRECCIÓN GENERAL DE SALUD PÚBLICA. SUBDIRECCIÓN GENERAL DE SEGURIDAD ALIMENTARIA Y LABORATORIOS DE SALUD PÚBLICA Public authority, ESP model reads as: wants changes source
  • The regulation must explicitly guarantee preservation of existing levels of food law and not compromise the precautionary principle in biotechnology applications affecting the food chain.

    the current wording does not explicitly guarantee the preservation of existing levels of food law.

    machine translation by the Commission, original in ES
  • The proposal must specify how risk assessments of biotechnological applications with food implications will maintain independence, scientific rigour, and harmonised criteria between Member States.

    The proposal addresses the need for more agile regulatory frameworks, including sandboxes and fast-track procedures, but does not specify how it will be ensured that risk assessments of biotechnological applications with food implications maintain: independence, scientific rigour, harmonised criteria between Member States.

    machine translation by the Commission, original in ES
  • The Regulation must incorporate clear and harmonised requirements for complete traceability of micro-organisms, enzymes, and metabolites used in biotechnological processes.

    It is proposed that the Regulation incorporates clear and harmonised requirements to: full traceability of the origin and destination of micro-organisms or metabolites used in biotechnological processes, interoperability between operators and authorities, integration with official food control systems.

    machine translation by the Commission, original in ES
• EIT Health Other, DEU model reads as: supports source
  • EIT Health seeks to be involved in the implementation of the Biotech Act to strengthen EU biotech competitiveness.

    EIT Health stands ready to contribute to the implementation of the Biotech Act and to support a more competitive and innovation-driven biotech landscape in Europe.

• EORTC NGO, BEL model reads as: wants changes source
  • Establish a revisited definition and simple regulatory process for low-intervention clinical trials (LICTs) as called for in the attached Annex.

    To tackle this, we are calling for a revisited definition and a simple regulatory process for LICTs (in attached Annex).

  • Make LICTs eligible for a simplified regulatory pathway equivalent to that proposed for minimal-intervention clinical trials.

    To better support this research, these trials, much like minimal-intervention clinical trials, should be eligible for a simplified regulatory pathway.

  • Require only Ethics Committee approval for LICTs instead of all standard regulatory requirements designed for standard trials.

    Instead of fulfilling all regulatory requirements that are designed for standard trials, these trials should only need Ethics Committee approval (as is the case for the proposed minimal-intervention category).

• Nemzeti Agrárgazdasági Kamara Other, HUN model reads as: supports source
  • Maintain regulatory sandboxes allowing Member States to establish controlled environments for food business operators to test innovative products and processes at pre-marketing stages.

    The proposal allows Member States to set up sandboxes at all stages of production, processing and distribution of food.

    machine translation by the Commission, original in HU
  • Extend EFSA's role to provide pre-submission scientific advice to food business operators and SMEs on study design and testing strategies prior to application submission.

    The role of the European Food Safety Authority (EFSA) is extended to provide applicants (e.g. food processors) with scientific advice on study design and testing strategies prior to the submission of an application.

    machine translation by the Commission, original in HU
  • Expedite market access for genetically modified micro-organisms in food applications to bring these innovative solutions to the EU market faster and at lower cost.

    The proposal aims to bring these innovative solutions to the EU market faster and at a lower cost.

    machine translation by the Commission, original in HU
• Plants for the Future European Technology Platform Other, BEL; register: Other organisations, public or mixed entities model reads as: wants changes source
  • Explicitly integrate agricultural biotechnology into the scope of the European Biotech Act II as a structural component

    Biotech ActII is therefore the opportunity to explicitly and structurally address agricultural biotechnology within the European Unions biotechnology framework.

  • Better reflect the strategic importance of agricultural biotechnology in addressing climate change, food security and sustainable development

    the proposal insufficiently reflects the strategic importance of agricultural biotechnology, notwithstanding the Acts repeated references to food systems, sustainability, climate resilience and the bioeconomy.

  • Ensure Europe harnesses biotechnology as a truly cross-sectoral strategic technology across health, agriculture and bioeconomy sectors

    ensure that Europe fully harnesses biotechnology as a truly cross-sectoral strategic technology.

• The European Network of Research Ethics Committees (EUREC), the Standing Committee of European Doctors (CPME), and the Council for International Organizations of Medical Sciences (CIOMS) welcome the European Commission’s Biotech Act Proposal as an im Other, DEU model reads as: wants changes source
  • Strengthen responsible inclusion of pregnant and lactating women in clinical trials through amendments to article 33 of the Clinical Trials Regulation to address longstanding exclusion.

    First, we propose strengthening responsible inclusion, particularly regarding pregnant and lactating women, through amendments to art. 33 CTR to address longstanding exclusion from research and the resulting lack of evidence-based treatments.

  • Explicitly integrate patient and public involvement and engagement (PPIE) through a new recital and new provision in article 28 of the Clinical Trials Regulation.

    Second, we propose the explicit integration of patient and public involvement and engagement (PPIE) through a new recital and a new provision in art. 28 CTR.

  • Revise data protection provisions in article 93 of the Clinical Trials Regulation to ensure appropriate balance between research efficiency, transparency, and personal data protection.

    Third, we recommend revising the proposed data protection provisions in art. 93 CTR to ensure an appropriate balance between research efficiency, transparency, and personal data protection, while maintaining public trust in clinical research.

• WePlanet NGO, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Remove the exclusion of novel foods from the regulatory sandbox scheme during the legislative process.

    We call on the Commission and co-legislators to remove this exclusion during the legislative process.

  • Ensure Biotech Act II explicitly supports Advanced Fermentation as a strategic technology for EU food system resilience.

    WePlanet urges the Commission to ensure that Biotech Act II explicitly supports Advanced Fermentation encompassing precision fermentation, biomass fermentation, and related approaches as a strategic technology for EU food system resilience.

• Psychedelic Access and Research European Alliance (PAREA) NGO, EST; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Recognise mental health as a strategic area of high public health and socioeconomic burden with persistent innovation gaps.

    Recognise mental health as a strategic area of high public health and socioeconomic burden with persistent innovation gaps.

  • Ensure that regulatory sandboxes, including clinical trial sandboxes, can be used for complex mental health innovations where standard development pathways are not well suited.

    Ensure that regulatory sandboxes, including clinical trial sandboxes, can be used for complex mental health innovations where standard development pathways are not well suited.

  • Include mental health innovation gaps in the strategic mapping of the Union biotechnology ecosystem, covering clinical development capacity, access to risk-tolerant capital, data infrastructure, regulatory uncertainty, cross-border scale-up and real-world implementation.

    Include mental health innovation gaps in the strategic mapping of the Union biotechnology ecosystem, covering clinical development capacity, access to risk-tolerant capital, data infrastructure, regulatory uncertainty, cross-border scale-up and real-world implementation.

• European industry Trade Association for Contract Research Organizations Other, NLD; register: Trade and business associations model reads as: wants changes source
  • Accelerate multinational trial authorization to 60 days and single-country trials to 30 days to match global competition.

    Europe should be even more ambitious and aim for 60-day multinational trial authorization (vs. current 106 days) and 30 days for single-country trials to match global competition.

  • Clarify that the Reporting Member State determines the approach to fulfil Part I conditions applicable to all Member State Competent authorities.

    EUCROF seeks clarifying language that it is the Reporting Member State that determines the approach how to fulfil Part I conditions, which should be applicable to all MSCs.

  • Establish specific procedures and resources for complex and cross-border clinical trials aligned with ICH E6 (R3) and Declaration of Helsinki.

    Cross-border trials should be a given, at least within the EU and in the light of the future EDHS. Again, this is now the chance to prepare for the future, and resource the ability for cross-border trials adequately.

• Childhood Cancer International - Europe NGO, AUT; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • The Act should address market failure for children with rare life-threatening diseases through targeted incentives, procurement agreements, and funding streams.

    Addressing the market failure for children with rare life-threatening diseases through targeted incentives, procurement agreements, and funding streams;

  • The Act should ensure prioritisation of paediatric cancers within strategic projects.

    Ensuring prioritisation of paediatric cancers within strategic projects;

  • The Act should embed patient involvement and ethical governance.

    Embedding patient involvement and ethical governance;

• Micro company, BEL NGO, BEL model reads as: wants changes source
  • Introduce a 12-month patent extension incentive for first-in-child medicines whose first authorized indication specifically targets rare life-threatening paediatric diseases.

    SIOPE calls on the EU to be a champion for children with rare life-threatening diseases by introducing a targeted incentive for first-in-child medicine development in the Biotech Act I, such as by adding a new section in Article 27. The incentive can take the form of an additional 12-month patent extension for medicinal products whose first authorized indication specifically targets rare life-threatening paediatric diseases.

  • Clarify Article 27(b) to ensure incentives apply also where there is no existing curative treatment available.

    Together with the above, SIOPE calls for an additional clarification in current Article 27 - point (b) that incentives apply also where there is no existing curative treatment available at all.

  • Allocate dedicated public funding to research and non-profit projects and platforms addressing rare paediatric diseases.

    EU programmes should allocate dedicated public funding to research and other non-profit projects & platforms addressing rare paediatric diseases, recognising market failures in this area.

• Fraunhofer-Gesellschaft Academic or research institution, DEU; register: Think tanks and research institutions model reads as: supports source
  • Biotech Act I must lay the regulatory and structural groundwork by harmonizing the fragmented European biotech landscape and reducing barriers to market entry.

    Biotech Act I must lay the regulatory and structural groundwork: harmonizing the fragmented European biotech landscape, reducing barriers to market entry, aligning the incentive frameworks of the MDR, AI Act, and sector-specific regulations, and establishing the investment conditions needed to retain and scale European biotech innovation.

  • The Commission should propose Biotech Act II without delay and without compromise on ambition, covering the full breadth of biotechnology's transformative potential.

    Fraunhofer calls on the Commission to honour the commitment to propose Biotech Act II without delay and without compromise on ambition.

  • The two Acts must form a coherent, interlocking framework covering the entire biotechnology value chain from fundamental research through to sovereign digital health infrastructure.

    Together, the two Acts must form a coherent, interlocking framework that covers the entire biotechnology value chain: from fundamental research and clinical translation, through industrial scaling and circular material flows, to resilient agricultural systems and sovereign digital health infrastructure.

• Federacja Przedsiębiorców Polskich Business association, POL; register: Trade and business associations model reads as: wants changes source
  • Expand the scope to cover the full biotechnology value chain from R&D to patient access and include hospital networks and clinical sites in Centres of Excellence for Advanced Therapies.

    recommends that the final Act cover the full biotechnology value chain: from R&D, manufacturing and clinical trials to clinical deployment, post-authorisation evidence generation, HTA and patient access. FPP recommends expanding Centres of Excellence for Advanced Therapies beyond research and manufacturing hubs to include hospital networks and specialised clinical sites administering authorised ATMPs.

  • Strengthen the EU clinical trials framework by establishing a Clinical Trials Expert Committee role in multinational trials, shortening timelines, and reducing duplication through an investigational medicinal product core dossier.

    recommends improving the EU clinical trials framework by strengthening the role of a Clinical Trials Expert Committee in multinational trials, shortening and structuring timelines, limiting grounds for Member State disagreement, facilitating combined studies with medical devices or IVDs, and reducing duplication through mechanisms such as an investigational medicinal product core dossier.

  • Broaden the scope of the 12-month SPC extension and replace the cumulative eligibility test with a more flexible model rewarding both therapeutic innovation and investment in the EU.

    FPP supports the proposed 12-month SPC extension, but recommends broadening its scope and replacing the cumulative eligibility test with a more flexible model rewarding both therapeutic innovation and investment in the EU.

• Life Science Manufacturers Association Business association, BEL; register: Trade unions and professional associations model reads as: wants changes source
  • Create an Advanced Biomanufacturing Technology (ABT) Designation to recognize and accelerate integration of innovative manufacturing technologies.

    LSMA proposes the creation of an Advanced Biomanufacturing Technology (ABT) Designation to fill this gap.

  • Amend the Biotech Act to give operative effect to the ABT Designation by aligning provisions on strategic projects, regulatory sandboxes, funding, and the regulatory repository.

    LSMA therefore proposes targeted amendments to the EU Biotech Act to give the ABT Designation operative effect by aligning the relevant provisions on strategic projects, regulatory sandboxes, funding, and the Union regulatory repository.

  • Establish mechanisms that enable rapid adoption of advanced, high-quality and cleaner manufacturing technologies to translate scientific excellence into scalable production capacity.

    Enabling the rapid adoption of advanced, high-quality and cleaner manufacturing technologies is essential if Europe is to translate its scientific excellence into scalable, resilient and globally competitive production capacity.

• Japan Business Council in Europe Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Refine SPC extension conditions to treat manufacturing in trusted partner countries such as Japan as equivalent to EU manufacturing.

    refine the SPC extension conditions in Article 27 so that they operate as a non-discriminatory, innovation-oriented incentive and treat manufacturing in trusted partner countries such as Japan as equivalent to EU manufacturing

  • Reflect the strategic value of cooperation with trusted partners in Strategic Projects criteria and broaden the scope of international cooperation.

    reflect the strategic value of cooperation with trusted partners in the Strategic Projects criteria (Article 3) and broaden the scope of international cooperation under Article 30

  • Expand the definition of biomanufacturing to include pre-commercial manufacturing.

    expand the definition of biomanufacturing (Article 2(1)(5)) to include pre-commercial manufacturing

• European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Strengthen support for innovative small- and mid-sized companies in the biopharmaceutical sector.

    strengthen support for innovative (small- and mid-sized) companies

  • Enhance regulatory predictability to reduce barriers for biotech companies.

    enhance regulatory predictability

  • Facilitate the development and uptake of cutting-edge therapies across the EU.

    facilitate both the development and uptake of cutting-edge therapies across the EU

• AseBio Business association, ESP; register: Trade and business associations model reads as: wants changes source
  • Regularly update the definition of biotechnology to reflect scientific advances and explicitly include animal health within health biotechnology.

    AseBio recommends regularly updating the definition of biotechnology to reflect scientific and technological advances while maintaining the current regulatory scope. We also propose explicitly including animal health within health biotechnology

  • Provide clearer definitions of key concepts for Strategic Biotechnology Projects including 'substantial contribution,' 'high impact,' and 'systemic and catalytic potential.'

    Key concepts such as "substantial contribution," "high impact," and "systemic and catalytic potential" require clearer definitions.

  • Clarify funding, eligibility and financial mechanisms for the proposed investment instruments to strengthen implementation.

    The proposed investment instruments require greater clarity on funding, eligibility and financial mechanisms.

• Sanofi Company, FRA; register: Companies & groups model reads as: wants changes source
  • Establish a Voluntary European Clinical Trial '28th Regime' as an optional pathway for willing Member States to conduct single coordinated assessment with mutual recognition.

    a Voluntary European Clinical Trial "28th Regime" an optional pathway for willing Member States based on a single coordinated assessment, a Common Assessment Report and mutual recognition.

  • Adjust SPC incentive conditionality to reflect real investment decisions, maintain broad technology-neutral eligibility, and ensure the extension captures biologics, ATMPs, nucleic-acid therapies, mRNA and biotechnologically produced vaccines and enzymes.

    adjusting conditionality to reflect real investment decisions, maintaining broad and technology-neutral eligibility, and ensuring the extension references the Article 2 definition so it captures biologics, ATMPs, nucleic-acid therapies, mRNA and biotechnologically produced vaccines and enzymes.

  • Mandate the Commission to assess an EU lead-market strategy for health biotechnology and explore a European competitiveness top-up within the next multiannual budget co-financing national spending on qualifying medicines and vaccines.

    the Commission be mandated to assess an EU lead-market strategy for health biotechnology (coordinated uptake, innovative procurement, investment predictability), and explore a European competitiveness top-up within the next multiannual budget that co-finances a defined share of national spending on qualifying innovative medicines and vaccines with national pricing and reimbursement decisions untouched all while respecting Member State competencies.

• Micro company, BEL Academic or research institution, BEL model reads as: wants changes source
  • Integrate paediatric research and innovation throughout the entire biotechnology development pathway from early development to clinical implementation.

    EPTRI recommends integrating paediatric research and innovation throughout the entire biotechnology development pathway, from early development to clinical implementation.

  • Strengthen collaboration between ERNs, paediatric research infrastructures, clinical trial and specialty networks, specialised centres, registries and natural history platforms.

    The Act should also strengthen collaboration between ERNs, paediatric research infrastructures, clinical trial and specialty networks, specialised centres, registries and natural history platforms.

  • Explicitly recognise paediatric research and innovation as a strategic pillar of European biotechnology policy.

    EPTRI therefore recommends that the final Biotech Act explicitly recognises paediatric research and innovation as a strategic pillar of European biotechnology policy, strengthening Europe's scientific leadership, competitiveness and healthcare sustainability while ensuring that children benefit equitably from biotechnology innovation.

• Centre for Long-Term Resilience Other, GBR; register: Think tanks and research institutions model reads as: supports source
  • Set a clear timeline for the pathway to harmonised nucleic acid synthesis screening across the Union.

    Set a clear timeline (for example, 18 months) for the pathway to harmonised screening across the Union.

  • Give explicit priority to biodefence projects within the financing provisions.

    Give explicit priority to biodefence projects within the financing provisions (Articles 22-26).

  • Reject amendments that would strip the Advisory Group of its ability to issue qualified alerts and amendments separating civilian and defence sector interactions.

    Reject proposed amendments that would strip the Advisory Group of its ability to issue qualified alerts (Amendment 2432) and amendments that seek to separate civilian and defence/security sector interactions in biotechnology projects (Amendments 2404, 2407, 2411).

• Djurens Rätt NGO, SWE; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • The Biotech Act should clearly prioritise non-animal methods and serve as a driver for transition to innovative, human-based and non-animal research.

    The Biotech Act should clearly prioritise non-animal methods and be used as a driver for the transition to more innovative, human-based and non-animal research.

    machine translation by the Commission, original in SV
  • The EU should strengthen investment in non-animal methods through research, infrastructure, education and skills development.

    The EU should strengthen investment in non-animal methods by investing in research, infrastructure, education and skills development, benefiting people, animals and the environment and strengthening Europe's competitiveness.

    machine translation by the Commission, original in SV
  • The Biotech Act should be coordinated with EU efforts to phase out animal testing and ensure inclusion of experts in non-animal methods and animal welfare organisations.

    The Biotech Act should be coordinated with the EU's efforts to phase out animal testing and ensure that experts in non-animal methods, as well as patient and animal welfare organisations, are included in its work.

    machine translation by the Commission, original in SV
• Biomedical Alliance in Europe Other, BEL; register: Trade unions and professional associations model reads as: wants changes source
  • Recognise academic and non-commercial research organisations as strategic contributors to Europe's biotechnology ecosystem.

    Recognise academic and non-commercial research organisations as strategic contributors to Europes biotechnology ecosystem

  • Include concrete mechanisms to support low-intervention clinical trials and simplify regulatory processes for them.

    Include concrete mechanisms to support low-intervention clinical trials (LICTs) and simplify regulatory processes for LICTs.

  • Establish dedicated EU support mechanisms for academic biotechnology development, including late-stage clinical research and pivotal clinical trials.

    Establish dedicated EU support mechanisms for academic biotechnology development, including late-stage clinical research and pivotal clinical trials.

• EuropaBio - the European Association for Bioindustries Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Strategic and high-impact projects require clear criteria, binding guidance and predictable procedures to avoid divergent national interpretation.

    Recognition of strategic and high-impact projects requires clear criteria, binding guidance and predictable procedures.

  • The investment pilot should run for a minimum of seven years under the next Multiannual Financial Framework to align with pension fund investment cycles.

    Therefore, the investment pilot should run for a minimum of seven years under the next Multiannual Financial Framework, since a two-year horizon is shorter than the investment cycle of the pension funds and insurance undertakings it is designed to attract.

  • National export controls should have mandatory processing timelines, written justification for refusals, and published criteria.

    National export controls require particular attention: Member States operate with no mandatory timelines, no obligation to justify refusals and no transparency on the criteria applied. Authorisation requests should be processed within a published timeframe, refusals justified in writing, and criteria published.

• Novo Nordisk A/S Company, DNK; register: Companies & groups model reads as: wants changes source
  • Apply a non-cumulative model for Article 27 eligibility criteria whereby only two of four criteria need to be met for the SPC extension.

    Novo Nordisk recommends applying a non-cumulative model whereby only two of four criteria need to be met for companies to be eligible for the 12-month SPC extension.

  • Establish a one-door entry system with a single accountable regulatory body for integral drug-device combination products.

    A one-door entry system with a single accountable regulatory body would eliminate duplicate assessment and enable earlier patient access to new treatments.

  • Harmonize data standards and regulatory requirements across Member States to facilitate AI development in the pharmaceutical sector.

    AI development requires large amounts of harmonised data which currently dont exist as there are no common standards guiding the integration of multimodal data.

• Fresenius Company, DEU; register: Companies & groups model reads as: wants changes source
  • Maintain the waiver of Comparative Efficacy Studies (Phase III) for biosimilars with demonstrated similarity to reference medicines through analytical, functional, and pharmacokinetic evidence.

    In particular, the proposed waiver of Comparative Efficacy Studies (Phase III) for biosimilars where similarity to the reference medicine can be sufficiently demonstrated through comprehensive analytical, functional, and pharmacokinetic evidence has the potential to make biosimilar development more efficient while maintaining established standards for quality and safety.

  • Reject or reconsider the proposed 12-month extension of the Supplementary Protection Certificate (SPC) as it could delay biosimilar competition and increase healthcare costs.

    The proposed 12-month extension of the Supplementary Protection Certificate (SPC) could delay biosimilar competition and increase healthcare costs without clear evidence that it would generate additional investment or manufacturing in Europe.

  • Strengthen the SPC Manufacturing Waiver to support EU-based biosimilar manufacturing and ensure European manufacturers are not disadvantaged compared to competitors outside the EU.

    Instead of extending market exclusivity, the Biotech Act should strengthen the SPC Manufacturing Waiver to support EU-based biosimilar manufacturing, enable timely market entry and improve competitiveness by ensuring that European manufacturers are not placed at a disadvantage compared with competitors producing outside the EU.

• Pharma Deutschland e.V. Business association, DEU; register: Trade and business associations model reads as: wants changes source
  • Reduce unnecessary administrative complexity and improve legal certainty throughout the Biotech Act.

    the final Regulation should further reduce unnecessary administrative complexity, improve legal certainty and strengthen coherence with existing EU legislation

  • Simplify and accelerate multinational clinical trials by reducing timelines and improving the Clinical Trials Information System.

    Europe should continue to simplify and accelerate multinational clinical trials by further reducing timelines where operationally feasible, improving the functionality of the Clinical Trials Information System (CTIS), enabling parallel assessment of core dossier and trial-specific modifications, promoting greater convergence of ethics reviews and supporting fully digital clinical trial processes.

  • Ensure AI systems are not subject to duplicative regulatory requirements when assessed within established pharmaceutical procedures.

    AI systems assessed within established pharmaceutical regulatory procedures should not be subject to duplicative regulatory requirements.

• European Patient Organisation for Dysimmune and Inflammatory Neuropathies (EPODIN) NGO, FRA; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Establish an EU mechanism to monitor equitable patient access by tracking time from EU marketing authorisation to national reimbursement decisions and first patient access.

    First, establish an EU mechanism to monitor equitable patient access by tracking the time from EU marketing authorisation to national reimbursement decisions and first patient access, monitoring the availability of innovative medicines across Member States, publishing regular benchmarking reports, and supporting greater convergence between national early access schemes to reduce avoidable administrative and reimbursement delays.

  • Accelerate clinical research while ensuring it remains patient-centred, with faster procedures for multinational trials involving orphan and immunology therapies.

    Second, accelerate clinical research while ensuring it remains patient-centred. Faster and more efficient procedures, particularly for multinational trials involving orphan and immunology therapies, are essential to strengthen Europe's attractiveness for clinical research, expand opportunities for patients to participate in innovative trials and accelerate access to new medicines.

  • Establish a European Real-World Evidence framework coordinated by EMA and Health Technology Assessment bodies to support systematic use of RWE in regulatory and post-authorisation decision-making.

    Third, establish a European Real-World Evidence framework, coordinated by the European Medicines Agency and Health Technology Assessment bodies, to support the systematic use of RWE in regulatory and post-authorisation decision-making.

• BPI German Pharmaceutical Industry Association Business association, DEU; register: Trade and business associations model reads as: wants changes source
  • Ensure all relevant bodies are adequately resourced and closely coordinated with clearly delineated mandates to prevent duplication and regulatory conflict.

    All relevant bodies, both new and existing, should therefore be adequately resourced in terms of time, expertise, funding, and staff, and closely coordinated with existing EU and national structures. Their mandates should be clearly delineated to prevent duplication, regulatory conflict, and unnecessary administrative complexity.

  • Use broader terminology to include healthcare providers and industrial actors across the Union, not just SMEs and start-ups.

    BPI therefore calls for the consistent use of the broader terminology already used in Art.15(2)(d), namely SMEs, start-ups and scale-ups, health care providers, and industrial actors from across the Union.

  • Explicitly include substances of human origin in the Act given their importance for ATMPs and innovation potential.

    In this context, substances of human origin should be explicitly included in the Act, given their importance for ATMPs and their significant innovation potential.

• Standing Committee of European Doctors (CPME) NGO, BEL; register: Trade unions and professional associations model reads as: wants changes source
  • Strengthen responsible inclusion of pregnant and lactating women by amending article 33 CTR to address their historical exclusion from research.

    First, we propose strengthening responsible inclusion, particularly regarding pregnant and lactating women, through amendments to art. 33 CTR to address longstanding exclusion from research and the resulting lack of evidence-based treatments.

  • Explicitly integrate patient and public involvement and engagement (PPIE) through new provisions in article 28 CTR.

    Second, we propose the explicit integration of patient and public involvement and engagement (PPIE) through a new recital and a new provision in art. 28 CTR.

  • Revise data protection provisions in article 93 CTR to balance research efficiency, transparency, and personal data protection.

    Third, we recommend revising the proposed data protection provisions in art. 93 CTR to ensure an appropriate balance between research efficiency, transparency, and personal data protection, while maintaining public trust in clinical research.

• Marseille Immunology Biocluster Academic or research institution, FRA model reads as: wants changes source
  • Financing instruments including EIF co-investment must explicitly target the seed range for academic spinoffs and cluster-level vehicles should qualify for preferential access conditions with reduced administrative burden.

    the financing instruments including EIF co-investment must explicitly reach the seed range where academic spinoffs face their steepest funding gap, and cluster-level vehicles should qualify for preferential access conditions to showcase their pipeline without excessive administrative burden.

  • The Act should recognize the evolving nature of biotechnology innovation in immunology and advanced therapies, particularly regarding shared scientific foundations and novel development and manufacturing approaches.

    the Act should recognize the evolving nature of biotechnology innovation, particularly in areas such as immunology and advanced therapies, where breakthrough products are often developed from shared scientific and technological foundations and rely on novel development and manufacturing approaches.

  • Co-legislators should further harmonize regulatory requirements and promote coordinated assessment procedures across Europe to enable faster initiation of first-in-human and proof-of-concept clinical trials.

    MIB therefore encourages the co-legislators to further harmonise regulatory requirements and promote coordinated assessment procedures across Europe, enabling faster and more efficient initiation of first-in-human and proof-of-concept studies.

• Corbion Company, NLD; register: Companies & groups model reads as: wants changes source
  • Pre-submission advice should be provided through confidential one-to-one meetings between applicants and EFSA.

    To maximise effectiveness, this advice should be provided through confidential one-to-one meetings, enabling targeted discussions and the exchange of sensitive information.

  • The three-month notification period should begin from the date EFSA formally notifies the applicant.

    To enhance legal certainty and transparency, the three-month period should begin from the date on which EFSA formally notifies the applicant.

  • Novel foods should be eligible for inclusion in regulatory sandboxes for testing innovations.

    Corbion believes that novel foods should not be excluded from these sandboxes.

• PHARMABIOTIC RESEARCH INSTITUTE NGO, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Explicitly recognize microbiome-based innovations as a strategic biotechnology field within the Biotech Act framework.

    PRI believes that the proposal could be further strengthened by explicitly recognising microbiome-based innovations as a strategic biotechnology field.

  • Encourage greater regulatory convergence and structured scientific dialogue across competent authorities handling different regulatory pathways.

    PRI therefore encourages greater regulatory convergence and structured scientific dialogue across competent authorities.

  • Ensure the Act effectively addresses biotechnology sectors with complex living systems, multidisciplinary evidence requirements, and multiple regulatory pathways.

    ensure that the measures introduced by the Biotech Act effectively address biotechnology sectors characterised by complex living systems, multidisciplinary scientific evidence and multiple regulatory pathways

• Micro company, FIN Business association, FIN model reads as: supports source
  • Establish regulatory sandboxes especially for health biotechnology products with unclear regulatory status.

    Regulatory sandboxes, especially for health biotechnology products the regulatory status of which may be unclear.

  • Consult with stakeholders regarding medical devices and in vitro diagnostics in relation to health biotechnology.

    Our association remains available to provide additional expertise especially regarding health biotechnology in relation to medical devices and IVDs.

• Revitalised Medicine NGO, USA model reads as: wants changes source
  • Introduce an EU-wide biotechnology skills agenda with academic-industry partnerships and formal certifications in regulatory science to address workforce shortages and enhance innovation capacity.

    To spearhead this initiative, an EU-wide biotechnology skills agenda, that supports academic-industry partnerships and introduces formal certifications in regulatory science should be introduced.

  • Define standardized validation benchmarks and publish compliance guidelines for AI-integrated biotechnology products to enable safe adoption and enhance therapeutic precision.

    Defining standardized validation benchmarks and publishing compliance guidelines for AI-integrated products.

  • Establish frameworks promoting strategic domestic biomanufacturing capacity building to strengthen supply chain resilience and ensure sustainable biomedical product generation.

    frameworks promoting strategic domestic capacity building enhances security without undermining market principles, allowing for sustainable and efficient biomedical product generation.

• Confederation of Danish Industry - DI Food Business association, DNK; register: Trade and business associations model reads as: wants changes source
  • Reconsider the exclusion of novel foods from regulatory sandboxes to allow for regulated experimentation and learning.

    We therefore encourage policymakers to reconsider this exclusion.

  • Develop a comprehensive Biotech Act II that incorporates the food manufacturing sector and recognizes its strategic role.

    We thus ask the Commission for a strong Biotech Act II that incorporates the food manufacturing sector comprehensively and recognizes its strategic role for food security and sustainability.

  • Enable novel food innovations to benefit from regulatory experimentation through sandbox participation.

    Allowing novel food innovations to benefit from regulatory experimentation could strengthen the proposal even further.

• Agencia Estatal CSIC Academic or research institution, ESP; register: Think tanks and research institutions model reads as: wants changes source
  • Include a dedicated regulatory chapter on assisted and social robotics within the European regulatory framework.

    To address these challenges, CSIC proposes the inclusion of a dedicated regulatory chapter on assisted and social robotics within the European regulatory framework.

• EU Specialty Food Ingredients Business association, BEL; register: Trade and business associations model reads as: supports source
  • Implement the proposed changes to the General Food Law in the European Biotech Act to reduce regulatory burden on the specialty food ingredients sector.

    Our federation therefore sees the proposed changes to the General Food Law in the European Biotech Act as a step into the right direction.

  • Address the bureaucracy and lengthy regulatory processes that discourage applications at EU level.

    our sector has grown increasingly sceptical about the value of submitting applications at EU level, viewing it as a waste of money and effort because of increased bureaucracy and lengthy regulatory processes.

• Gobierno de Canarias Public authority, ESP model reads as: wants changes source
  • Regional health services and public hospitals should be recognized as eligible and priority actors in strategic projects and European health biotechnology networks, not only as beneficiaries.

    They should therefore be recognised not only as beneficiaries, but also as eligible and priority actors in strategic projects and European health biotechnology networks.

    machine translation by the Commission, original in ES
  • The regulation must explicitly address the specificities of outermost regions by promoting their participation in European networks, access to funding, and strengthening of health, digital and data infrastructure.

    it is necessary for the Regulation to explicitly address the specificities of the ORs, in accordance with Article 349 of the Treaty, by promoting their participation in European networks for biomedical research, multi-centre clinical trials and strategic projects, as well as access to specific funding and the strengthening of their health, digital and data infrastructure.

    machine translation by the Commission, original in ES
  • Strengthen coordination between biotechnology product development and health technology assessment policies to ensure rigorous evaluation of innovation value from multiple perspectives.

    it is imperative to strengthen the coordination of the development of new biotechnology products with health technology assessment policies and health systems sustainability strategies, including medicines, medical devices, in vitro diagnostic devices and combination products.

    machine translation by the Commission, original in ES
• Evonik Company, DEU; register: Companies & groups model reads as: wants changes source
  • Shift from a process-based to a product-based, risk-proportionate regulatory framework.

    What is needed is a decisive shift towards a product based, risk proportionate regulatory framework that:

  • Expand the scope to cover industrial and environmental biobased applications beyond non-food and non-feed uses.

    Covers the full range of applications, including industrial and future bio based uses.

  • Introduce a clearly defined and streamlined pathway for low-risk GMMs.

    Introduces a clearly defined and streamlined pathway for low risk GMMs.

• Micro company, MEX Company, MEX model reads as: wants changes source
  • Expand the Biotech Act to include environmental biotechnology, industrial demonstration pilots, circular resource recovery, and scalable deployment pathways for SMEs and startups.

    the Biotech Act should not only focus on laboratory innovation, but also on: industrial demonstration pilots, environmental biotechnology, circular resource recovery, decentralized wastewater treatment, sludge valorization, digital environmental traceability, and scalable deployment pathways for SMEs and startups.

  • Establish pilot-scale infrastructure, industrial validation environments, and cross-border acceleration mechanisms to support emerging biotech startups outside major innovation ecosystems.

    One of the main barriers faced by emerging biotech startups outside major innovation ecosystems is the lack of access to pilot-scale infrastructure, industrial validation environments and cross-border acceleration mechanisms.

  • Ensure the Biotech Act incorporates strategic support, regulatory clarity, and industrial collaboration mechanisms to accelerate maturation of biotechnology solutions.

    strategic support, regulatory clarity and industrial collaboration can significantly accelerate the maturation of deep-tech environmental solutions.

• EBSA ivzw Business association, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Establish a harmonized regulatory framework across all biotechnology sectors from the outset instead of pursuing a staged approach.

    This staged approach, however, risks perpetuating sectoral fragmentation and misses the opportunity to establish a harmonised regulatory framework that encompasses all biotechnology applications from the outset.

  • Pursue regulatory alignment and ensure consistent treatment of comparable technologies across health, agriculture, and biomanufacturing sectors.

    urging policymakers to pursue alignment across health, agriculture and biomanufacturing, to name a few.

  • Define biosecurity requirements with clear, internationally-recognized standards that are risk-proportionate rather than vague or overly strict.

    EBSA calls for these requirements to be carefully calibrated, risk-proportionate, and underpinned by clear, internationally recognised standards.

• KickCancer NGO, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Implement targeted incentives, procurement agreements, and funding streams to address the market failure for children with rare life-threatening diseases.

    Addressing the market failure for children with rare life-threatening diseases through targeted incentives, procurement agreements, and funding streams

  • Prioritise paediatric cancers within strategic projects under the Act.

    Ensuring prioritisation of paediatric cancers within strategic projects

  • Adopt a more targeted, patient-centred approach to ensure EU biotechnology leadership translates into life-saving treatments for children with cancer.

    A more targeted, patient-centred approach will ensure that the EUs biotechnology leadership translates into innovative, life-saving treatments for every child affected by cancer in Europe.

• European Association of Nuclear Medicine NGO, AUT; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Explicitly recognize nuclear medicine within the Act's framework as a strategic health biotechnology area.

    Given its unique contribution to precision diagnostics, molecular imaging, and targeted radionuclide therapies, nuclear medicine should be explicitly recognized within this framework.

  • Make targeted adjustments to the legislation to address the specific characteristics of radiopharmaceuticals and decentralised production models.

    Without targeted adjustments, the legislation risks creating uncertainty, limiting innovation and reducing Europes attractiveness for radiopharmaceutical research and development.

  • Ensure the regulatory framework remains innovation-friendly while maintaining high standards of safety and patient protection.

    Europe must ensure its regulatory framework remains innovation-friendly while maintaining high standards of safety and patient protection.

• BEUC Consumer organisation, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Rather than extending the Supplementary Protection Certificate monopoly, the Union should prioritise public-health-driven incentives including Strategic Projects and milestone prizes.

    Rather than prolonging monopolies, the Union should prioritise publichealthdriven incentives, including funding for Strategic Projects and milestone prizes, to stimulate research and manufacturing without restricting competition.

  • Beneficiaries of Strategic Projects should adopt concrete measures that contribute to the availability and affordability of resulting health technologies set out in a public access plan.

    Beneficiaries should adopt concrete measures that contribute to the availability and affordability of resulting health technologies, set out in a public access plan.

  • Regulatory sandboxes should not be introduced for the food sector.

    Regulatory sandboxes are not appropriate for the food sector.

• BIOCODEX Company, FRA; register: Trade unions and professional associations model reads as: wants changes source
  • Ensure the framework addresses the needs of mid-sized innovative companies alongside start-ups and SMEs.

    ensuring that the framework also addresses the needs of mid-sized innovative companies alongside start-ups and SMEs

  • Strengthen the clinical research ecosystem.

    strengthen the clinical research ecosystem

  • Improve regulatory clarity for health biotechnologies.

    improve regulatory clarity for health biotechnologies

• European Federation of Associations of Health Product Manufacturers Business association, BEL; register: Trade and business associations model reads as: supports source
  • The regulatory framework should be predictable, proportionate and supportive of innovation throughout the entire product development lifecycle.

    Achieving the objectives of the Biotech Act will require not only scientific excellence but also a regulatory framework that is predictable, proportionate and supportive of innovation throughout the product development lifecycle.

• CropLife Europe Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Reform the EU GMO framework to focus stacked event requirements on three criteria, allow time-unlimited authorisations, and mandate animal studies only when a specific risk hypothesis exists.

    CropLife Europe recommends targeted reform to the EU GMO framework, including: (1) focusing stacked event data requirements to the three criteria outlined in Annex II, §1.2.2 of Implementing Regulation 503/2013 by accepting derogations; (2) amending Regulation 1829/2003 to allow time-unlimited authorisations; (3) mandating animal studies only when a specific risk hypothesis exists by amending Implementing Regulation 503/2013 or accepting derogation requests.

  • Ensure regulatory sandboxes are accessible to all types of innovation including GMO and novel foods.

    To ensure regulatory coherence and a level playing field, sandboxes should be accessible to all types of innovation, including GMO and novel foods (e.g. from precision fermentation and microbial production systems).

  • Exempt biotech-modified microorganisms from the GMO framework when used as biocontrols or biostimulants, regulating them exclusively under sectoral legislation.

    CropLife Europe therefore recommends that biocontrol and plant biostimulant products based on microorganisms modified through new genomic techniques as defined in EFSAs opinion from 2024, be explicitly exempted from Directive 2001/18/EC and regulated exclusively under sectoral legislation.

• Micro company, FRA NGO, FRA model reads as: wants changes source
  • The Act should explicitly integrate New Approach Methodologies (NAMs) into regulatory frameworks to align them with scientific advances.

    To address these challenges effectively, the Act should place greater emphasis on aligning regulatory frameworks with scientific advances, particularly through the integration of New Approach Methodologies (NAMs).

  • Establish harmonized validation and qualification pathways for NAM-derived data with adaptive regulatory tools such as sandboxes.

    This requires explicit recognition of NAM-derived data, harmonised validation or qualification pathways, and adaptive regulatory tools such as sandboxes.

  • Extend investment beyond data generation to include stewardship, harmonization, and secure data-sharing infrastructure aligned with FAIR principles.

    Investment should therefore extend beyond data generation to include stewardship, harmonisation, FAIR (Findable, Accessible, Interoperable and Reusable) principles, and secure data-sharing infrastructures.

• Micro company, BEL Other, BEL model reads as: wants changes source
  • Reject the proposed 12-month Supplementary Protection Certificate extension for biotechnological medicinal products.

    (1) reject the proposed 12-month SPC extension

  • Amend the SPC manufacturing waiver to allow follow-on manufacturers to produce and store their products throughout the entire SPC term and market them in countries where the certificate does not exist or has expired.

    (2) amend the SPC manufacturing waiver to allow follow-on manufacturers to produce and store their products throughout the entire SPC term, and to market them in countries where the corresponding certificate does not exist or has expired

  • Strengthen measures supporting biosimilar development, competition and uptake through strategic projects and proportionate evidence-based clinical data requirements.

    (3) strengthen measures supporting biosimilar development, competition and uptake, notably through strategic projects and a proportionate yet evidence-based approach to clinical data requirements

• Servier Company, FRA; register: Companies & groups model reads as: wants changes source
  • Adopt technological agnosticism and the broader biotechnology definition from Article 2 to ensure the framework recognizes innovation based on scientific complexity rather than production method.

    We call for technological agnosticism, recognizing innovation based on scientific complexity rather than production method, and adopting the broader biotechnology definition found in Article 2 to ensure the framework is future proof.

• Cancer Patients Europe NGO, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Make reducing inequalities in access to innovation an explicit objective of the Regulation.

    Reducing inequalities in access to innovation should become an explicit objective of the Regulation.

  • Reduce administrative and logistical barriers to cross-border clinical trial participation and strengthen cooperation between Member States.

    The Regulation should reduce administrative, financial and logistical barriers to cross-border clinical trial participation, strengthen cooperation and referral systems between Member States, support EU-wide recruitment of patients, and simplify multinational clinical trial approvals while maintaining robust patient safety, ethical oversight and meaningful patient involvement.

  • Ensure meaningful patient involvement in governance and link public investment to measurable improvements in patient access and health inequalities reduction.

    The Biotech Act should remain aligned with the wider European health legislative framework, ensure meaningful patient involvement in governance, implementation, monitoring and evaluation, preserve balanced innovation incentives alongside timely biosimilar competition, and link public investment to measurable improvements in patient access and reductions in health inequalities.

• Micro company, CZE Company, CZE model reads as: wants changes source
  • Include explicit provisions for cross-border participation in EU clinical trial legislation.

    Cross-border participation in clinical trials must be explicitly addressed in EU legislation - and it must happen now.

  • Establish a clear and workable legal framework enabling patients to participate in clinical trials across national borders without unnecessary administrative, financial, linguistic or logistical barriers.

    Europe needs a clear and workable legal framework that enables patients to participate in clinical trials across national borders without unnecessary administrative, financial, linguistic or logistical barriers.

  • Ensure every patient in need has realistic opportunity to access suitable clinical trials regardless of their country of residence.

    ensure that every patient in need has a realistic opportunity to access a suitable clinical trial, regardless of their country of residence.

• Bayer AG Company, DEU; register: Companies & groups model reads as: wants changes source
  • Maintain an SPC extension of at least 12 months with clear and proportionate eligibility criteria.

    Maintaining an SPC extension of at least 12 months, paired with clear and proportionate eligibility criteria that avoid overly restrictive conditions,

  • Implement improvements to the clinical trials framework with streamlined timelines and wide use of master files.

    Effectively implementing the proposed improvements to the clinical trials framework, including streamlined timelines, implementing core dossier and wide use of master files, to enhance predictability and accelerate patient access to innovation,

  • Foster strategic projects contributing to Union biotechnology objectives through industrial capacity, R&D, and AI technology enablement.

    Fostering strategic projects that contribute to the Unions biotechnology objectives, through either industrial capacity, research and development, and technology enablement including AI,

• Micro company, DEU Other, DEU model reads as: wants changes source
  • Encourage rapid expansion of the FAST EU project timeline initiatives.

    we encourage a swift expansion of the project.

  • Seek greater simplifications for low-intervention clinical trials analogous to those for minimal-intervention trials to strengthen academic research.

    Particularly for low-intervention clinical trials, greater simplificationsanalogous to the regulations for minimal-intervention clinical trialsshould be sought to strengthen academic research.

  • Expand the minimal-intervention clinical trials category to include OECD B1 group of trials.

    It is therefore requested that minimal-intervention clinical trials be expanded accordingly to include the OECD B1 group of clinical trials.

• Micro company, CZE NGO, CZE model reads as: wants changes source
  • Cross-border participation in clinical trials must be explicitly addressed in the Biotech Act regulation.

    Cross-border participation in clinical trials must be explicitly addressed in EU legislation - and it must happen now.

  • Establish a clear and workable legal framework enabling patients to participate in clinical trials across national borders without unnecessary barriers.

    Europe needs a clear and workable legal framework that enables patients to participate in clinical trials across national borders without unnecessary administrative, financial, linguistic or logistical barriers.

  • Ensure urgent inclusion in current legislative cycle to enable timely patient access to clinical trials.

    Patients lymphoma cannot wait for another legislative cycle. Their lives depend on timely access to appropriate clinical trials.

• GAIA (Global Action in the Interest of Animals) NGO, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Recognize non-animal biotechnologies including organoids, organs-on-chips, and computational modelling as a fully-fledged strategic component of the European biotechnology ecosystem.

    Non-animal biotechnologies, including models based on human cells and tissues, organoids, organs-on-chips, ex vivo methods, advanced imaging and computational modelling, should be recognised as a fully-fledged strategic component of the European biotechnology and life sciences ecosystem.

  • Provide comprehensive support throughout the entire development pathway of non-animal technologies from fundamental research through commercialisation and regulatory acceptance.

    The Biotech Act should therefore provide support throughout the entire development pathway of these technologies: fundamental research, access to human data and biological samples, specialised infrastructure, training, standardisation, independent validation, commercialisation and regulatory acceptance.

  • Make European and national funding prioritise projects using non-animal methods and only support animal models when scientifically appropriate alternatives are unavailable.

    European and national funding should prioritise projects that use non-animal methods or contribute to their development and adoption. Public funds should no longer automatically support animal models when scientifically appropriate non-animal methods are available.

• Micro company, FRA NGO, FRA model reads as: supports source
  • The regulation should promote the use of non-animal methods and transition away from animal use in health research and innovation.

    represents a significant opportunity to promote the use of non-animal methods and transition to health research and innovation that does no longer rely on animal use

  • The regulation should align with and support the EC roadmap on phasing out animal testing for chemical safety assessments.

    in line with the recent roadmap published by the EC on phasing out animal testing for chemical safety assessments and the European Research Area action on New Approach Methodologies

  • The regulation should create market opportunities for European companies and strengthen Europe's global competitiveness in biotech innovation.

    It would also create new market opportunities for European companies, and strengthen Europe's global competitiveness and leadership in science and innovation.

46 more analysed submissions on the consultation page.