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Biotech Act

Food safety, Public health

The biotech sector is research-driven, fast-moving and requires substantial and continuous public and private investments. Biotechnology is an enabling technology, which plays a critical role in several areas of the EU economy. The Biotech Act will propose a series of measures aiming at creating an enabling environment to accelerate the transition of biotech products and applications from the laboratory to factory and to the market while maintaining the highest safety standards for the protection of the population and the environment.

Links

Public consultation

ID: 14627

Lobbying Activity

130 responses

AmCham EU urges transatlantic cooperation for new Biotech Act

American Chamber of Commerce to the European Union, 11 Jun 2025

The organization requests regulatory coherence to avoid duplicative rules and expedited pathways for faster product approvals. They emphasize aligning EU standards with global frameworks and US regulatory agencies.
Transatlantic alignment and streamlined permits would reduce operational costs for US biotech investors.
Proponents of European strategic autonomy may see domestic sourcing priorities undermined by global chains.

Chemical Industry Urges Multi-Sectoral Approach to EU Biotech Act

European Chemical Industry Council, 11 Jun 2025

The organisation requests clear definitions of biotechnology and biomanufacturing, a multi-sectoral approach covering all sectors, clear delineation between different policies, and strong patent protections. They argue biotechnology serves multiple sectors with distinct regulatory requirements and investment profiles.
This would create a single market for sustainable products and avoid offshoring.
No clear harm to specific groups is identified in the feedback.

EFPIA Urges Stronger IP Rules for European Biotech Growth

European Federation of Pharmaceutical Industries and Associations, 11 Jun 2025

EFPIA calls for reinforced intellectual property rules, including removing the five-year cap on certificates. They also advocate for simplified clinical trial frameworks and incentives for private investment. The group suggests pension reforms to increase liquidity for venture capital and small enterprises.
These measures would secure research investments and improve competitiveness against the US and China.
Generic manufacturers face high financial penalties and delayed market entry from stricter patent enforcement.

Eurogroup for Animals Urges Support for Animal-Free Biotech Methods

Eurogroup for Animals, 11 Jun 2025

The organisation calls for support of cellular agriculture while rejecting insect farming as a sustainable solution. They urge the EU to prioritise animal-free methodologies like organ-on-chip and AI over traditional testing.
Adopting non-animal methods would advance the group’s core mission of animal protection.
The insect farming industry would lose access to critical EU financial support.

Finnish Forest Industry Urges Holistic Approach to EU Biotech Act

Finnish Forest Industries Federation (Metsäteollisuus ry), 11 Jun 2025

The federation emphasizes the Biotech Act must adopt a comprehensive approach including the forest sector. Biomanufacturing should be defined technology-neutrally, including chemical and mechanical processing of biomass into products. EU funding must better support higher Technology Readiness Levels to facilitate commercialization and innovation.
The industry would gain subsidies and market dominance by substituting fossil-based materials with wood.
Fossil fuel companies lose market share as regulations move to prioritize renewable wood-based products.

BASF urges EU to simplify GMO approvals and biotech rules

BASF SE, 11 Jun 2025

BASF calls for a drastic simplification of the authorization process for GMO cultivation and imports. They advocate for a feedstock-agnostic approach to support all biotech sectors and ensure competitiveness.
Lowering these regulatory barriers would reduce the substantial time and costs required for market entry.

Bayer urges EU Biotech Act to simplify agricultural regulations

Bayer AG, 11 Jun 2025

Bayer requests that agricultural biotechnology be included in the new Act's scope. They advocate for simplified approval processes and stronger intellectual property protections for research.
Faster market access and stronger patent protections would safeguard Bayer's high-cost research investments.
Groups advocating for the precautionary principle lose regular safety reviews for bio-engineered products.

Danish Industry demands broad Biotech Act with strong IP protection

Confederation of Danish Industry, 11 Jun 2025

DI urges a broad scope covering medical, food, and industrial sectors with streamlined approvals. They demand that intellectual property rights remain untouched and benchmarked against high global standards. Additionally, the group seeks better access to capital for scaling up late-stage production.
Streamlined approvals and rigid IP rules would protect high-value research and speed up sales.

Medicines for Europe urges major biotech investment to secure EU biosimilar leadership

MEDICINES FOR EUROPE, 11 Jun 2025

The organization requests substantial public investment in biosimilar R&D and manufacturing capacity, regulatory streamlining to waive default comparative efficacy studies, reformed procurement practices allowing multi-winner tenders, and harmonized IP rules including clarification of the Bolar exemption and ban on patent linkage.
This would reduce their development costs by eliminating expensive comparative efficacy studies and enable faster market entry and export opportunities.
Originator pharmaceutical companies lose extended market exclusivity periods and face increased competition from biosimilars.

FoodDrinkEurope urges faster market pathways for food biotech

FoodDrinkEurope, 10 Jun 2025

The group wants the food sector included in the Act to reduce regulatory complexity and speed up approvals. They also call for better risk communication and a strategic policy to boost private investment.
Simplified rules would lower compliance costs and improve the financial viability of new products.
International competitors lose their dominance as the EU seeks to close the innovation gap.

MedTech Europe calls for biotech funding and regulatory simplification

MedTech Europe, 11 Jun 2025

MedTech Europe recommends increased investment in research hubs and prioritized funding for medtech innovations. They call for regulatory simplification and fast-track pathways to prevent delays for patients. Furthermore, they support procurement models reflecting broad public health benefits.
Proposed regulatory simplification would lower market entry barriers and decrease operational compliance costs.

Consultation response

CropLife Europe, 6 Jun 2025

CropLife Europe supports the objective of the European Biotech Act to strengthen the EUs global competitiveness in biotechnology. We believe the Act must address the major regulatory and perception barriers that limit the potential of agricultural biotechnology to contribute to EU food security,…

Cepi urges Biotech Act to include forest-based industries

Confederation of European Paper Industries, 11 Jun 2025

Cepi urges the Commission to broaden the Biotech Act's scope to include high-potential sectors like the forest-based bioeconomy. They request that biorefineries and industrial biotechnology applications be fully integrated into the EU's regulatory and innovation frameworks.
Inclusion would provide the regulatory clarity and innovation incentives necessary for their biomanufacturing investments.
Fossil-based producers may lose out as renewable bio-based alternatives replace their materials in the market.

IFOAM Europe insists on strict GMO traceability in Biotech Act

International Federation of Organic Agriculture Movements EU Regional Group, 11 Jun 2025

The organization demands mandatory identification and traceability for all genetically modified products to protect GM-free production chains. They insist that new genomic techniques must meet the same biosafety and labeling standards as older GMOs. They also call for the polluter pays principle to prevent contamination of organic crops.
These regulations would protect the economic livelihoods and market integrity of organic farmers and processors.
Biotech developers and patent holders would face increased liability and restricted control over seed genetics.

Danish Chamber of Commerce urges ambitious EU Biotech Act

The Danish Chamber of Commerce, 11 Jun 2025

The group calls for a centralized EU one-stop shop to simplify procedures. They want stronger intellectual property protections and streamlined trials to attract investment. Finally, they recommend recognizing biosolutions as a distinct legislative sector.
Harmonized rules and enhanced data access would reduce administrative costs for companies.
Generic drug manufacturers and healthcare systems may face higher costs from extended patents.

Novo Nordisk Urges Stronger IP Protections and Streamlined Regulations

Novo Nordisk A/S, 11 Jun 2025

Novo Nordisk requests robust intellectual property frameworks, specifically ten years of data protection. They advocate for streamlining regulatory procedures to match global timelines. The company also suggests harmonizing clinical trial approvals across the EU.
Extended data protection and faster approvals would protect products and reduce investment risks.
Generic drug manufacturers would face significantly longer delays before entering the market.

EuropaBio demands Biotech Act to drive European industrial leadership

EuropaBio, 10 Jun 2025

EuropaBio requests a dedicated Biotech Omnibus Package to resolve barriers and streamline market access. They advocate for an EU biotech NASDAQ to help companies raise capital locally.
Faster permitting and better financing would prevent innovative companies from moving to non-EU markets.
Fossil-based product manufacturers would face increased competition from bio-based alternatives through new sustainability accounting.

Invest Europe Urges Faster Biotech Commercialization and Investment Incentives

Invest Europe, 6 Jun 2025

They request faster regulatory approvals and stronger intellectual property rights for innovation. The group calls for R&D tax incentives to attract long-term private capital. They support biotech regulatory sandboxes to test new models without full regulatory burdens.
These measures would de-risk R&D investments and increase confidence for private equity funds.
Competing innovation hubs like the US may lose market share and global capital.

Sanofi urges EU to centralize biotech approvals and funding

SANOFI, 11 Jun 2025

Sanofi requests a single EU approval system for clinical trials and a simplified regulatory framework. They also propose merging medical regulations and increasing high-risk investment support.
Standardized processes would allow Sanofi to launch products faster while reducing administrative burdens.
National regulatory bodies would see their influence diminished by centralized European oversight.

German chemical industry urges unified EU biotechnology regulatory framework

Verband der Chemischen Industrie e.V., 11 Jun 2025

The group wants a single regulatory framework that treats biotechnology as a cross-sectoral technology. They suggest moving away from rules designed for fossil-based products to streamline approvals. It is also vital to include large companies as partners in the biotech ecosystem.
Creating a separate track for biological products would reduce costs and regulatory friction.
Fossil-fuel industries may lose competitive advantages as regulations pivot toward biological production systems.

AstraZeneca urges ambitious EU Biotech Act to boost competitiveness

AstraZeneca PLC, 11 Jun 2025

AstraZeneca calls for an Act securing competitive IP and optimized clinical trial systems. They advocate for centralized diagnostic approvals and dedicated evidence frameworks for orphan drugs.
Centralization would reduce administrative burdens and provide greater certainty for AstraZeneca’s market entry timelines.
National ethics committees lose independent oversight as approval processes are centralized and harmonized.

MSD urges strong IP and streamlined biotech regulations

Merck Sharp Dohme Europe Belgium SRL, 11 Jun 2025

MSD calls for an accelerated and harmonized clinical trial framework across Europe. They also request strong, enforceable intellectual property rights to support innovation.
Streamlined processes and IP protections would make Europe a more attractive hub for MSD's investments.

European Patients' Forum Urges Patient-Centred Focus in Biotech Act

European Patients' Forum (EPF), 11 Jun 2025

The Forum demands a patient-centred framework prioritizing equal access and meaningful involvement in innovation. They advocate for rigorous safety safeguards and harmonized assessments to ensure timely treatment availability.
Patients would gain greater agency over their health data and more affordable, personalized treatments.
Biotech companies could face higher costs from mandatory patient involvement and stricter safety monitoring.

Vaccines Europe Urges Faster Approvals to Boost Lagging Innovation

Vaccines Europe, 11 Jun 2025

The group requests harmonized clinical trial frameworks and the expansion of fast-track regulatory pathways used during the pandemic. They also propose adopting common packaging standards and digital leaflets to ensure faster access and prevent supply shortages.
These reforms would lower operating costs and help the region attract more global clinical research funding.
National governments might face pressure to surrender authority over vaccine reimbursement and health budgets.

GSK urges health-specific focus and streamlined rules for biotech

GSK, 10 Jun 2025

GSK requests a tailored approach to healthcare biotechnology and the streamlining of clinical trial approvals. They also seek stronger intellectual property protections and safeguards for sensitive trade data.
Streamlined approvals and stronger data protections would reduce research risks and operational costs.
Environmental protection standards could be weakened by efforts to reduce regulatory impacts on production.

EURORDIS urges dedicated Rare Disease Cluster in Biotech Act

EUROPEAN ORGANISATION FOR RARE DISEASES, 11 Jun 2025

EURORDIS proposes a Rare Disease Cluster to consolidate fragmented efforts and strengthen competitiveness. They recommend adaptive approval pathways and greater acceptance of non-traditional evidence like surrogate endpoints. The group calls for strategic investment tailored to academic institutions and smaller developers.
Regulatory alignment would reduce the high development costs currently hindering smaller developers.

Euroseeds Urges Modernized Rules for Plant Breeding Innovation

Euroseeds, 10 Jun 2025

The organization requests a science-based, proportionate regulatory environment to support plant breeding. They argue for a differentiated framework for New Genomic Techniques and modernized GMO legislation.
Simplified regulations and targeted funding would lower R&D costs and market barriers.
Foreign biotech developers lose market dominance as European domestic production becomes viable.

Pfizer Calls for Faster Clinical Trials and Enhanced Biotech Funding

Pfizer Inc., 11 Jun 2025

Pfizer requests faster clinical trial approvals through early scientific dialogues and reinforced ethics review provisions. They want dedicated funding programs for biotech SMEs and support for specialized biohubs. They also seek expanded use of real-world data in regulatory decisions.
This would speed up drug approvals and reduce research costs through public funding.

DSW Urges EU Biotech Act Focus on Global Women’s Health

DSW (Deutsche Stiftung Weltbevoelkerung), 9 Jun 2025

DSW requests prioritising public spending on neglected diseases and closing the global women's health gap. They advocate simplifying regulatory pathways and creating dedicated funding streams for women-centric biotechnology. The group also recommends using incentive mechanisms like priority review vouchers and revenue guarantees.
This would increase development of new medical tools specifically designed for female biology.
National treasuries would face pressure to meet the three percent GDP research investment target.

Merck urges "Biotech Omnibus" to boost European innovation and competitiveness

Merck, 11 Jun 2025

Merck requests a "Biotech Omnibus" to simplify regulatory processes and accelerate market access. They want the EU budget to prioritize biotech and provide guarantee funds to lower investment risks. They also advocate for harmonizing clinical trial regulations to attract research.
This strategy would reduce Merck's financial risks while accelerating its product approvals.
Taxpayers would bear the financial burden if high-risk private projects fail.

EUCOPE demands tailored support for small and mid-sized biotech companies

European Confederation of Pharmaceutical Entrepreneurs, 11 Jun 2025

EUCOPE requests a sector-specific approach for healthcare biotech through a dedicated agency. They propose streamlining regulatory procedures and updating definitions for small and mid-sized companies. Finally, they advocate for easing GMO restrictions on advanced therapies to boost innovation.
Proposed changes would lower administrative costs and improve access to funding for smaller innovators.
Groups advocating for strict GMO oversight might oppose exemptions for biotech medicinal products.

Detergent industry urges Biotech Act to include cleaning products

Association Internationale de la Savonnerie, de la Détergence et des Produits d'Entretien, 6 Jun 2025

A.I.S.E. requests the Biotech Act explicitly include detergents and cleaning products. They advocate for risk-based assessments of enzymes to foster sustainable innovation. The association seeks harmonized GMO rules to reduce administrative burdens.
Inclusive rules would reduce costs and delays for bio-based product development.
National authorities would lose the power to impose unique local registration requirements.

Novo Nordisk Foundation urges EU to fast-track biotech approvals

Novo Nordisk Foundation, 11 Jun 2025

The Foundation requests the EU Biotech Act focus on areas most in need of support, primarily agriculture and food sectors. They also seek to stimulate private investments and create new large European funds for late-stage capital rounds.
These reforms would reduce operational hurdles and financial risks for their significant investment portfolio.
Conventional fossil-based industries lose market dominance to mandated sustainable bio-based alternatives.

Novonesis urges EU to accelerate biotech product market approvals

Novonesis A/S, 11 Jun 2025

Novonesis calls for a regulatory framework that streamlines approval timelines and speeds up market access. They request exemptions from restrictive chemical safety rules for biological solutions like enzymes.
Streamlined approvals would lower operational costs and increase their international market share.
Health advocates lose the safety guarantee provided by hazard-based chemical restrictions.

Wacker Chemie Urges EU to Simplify Biotech Regulatory Approvals

WACKER CHEMIE AG, 4 Jun 2025

Wacker Chemie requests simpler authorization for products equivalent to conventional versions. They advocate for subsidies on raw materials used in fermentation processes. They also want to exempt certain products from GMO labeling.
These changes would lower costs and speed up the delivery of biotech innovations.
Transparency advocates lose visibility because certain GMO-linked products would avoid labeling.

European Doctors Link Biotech Funding to Pharma Transparency

Standing Committee of European Doctors, 20 May 2025

Doctors urge linking biotechnology financial support to increased transparency in the pharmaceutical sector. They also emphasize maintaining high standards for clinical trials and effective regulation.
Greater transparency provides medical professionals with higher quality data for healthcare decisions.

Boehringer Ingelheim urges EU to prioritize biotech IP and research

Boehringer Ingelheim, 11 Jun 2025

The organization requests a robust and harmonized intellectual property framework to attract investment. They advocate for simplified clinical trial approvals and tools to de-risk manufacturing investments.
Stronger intellectual property rights and manufacturing support would protect their significant research investments.

AnimalhealthEurope urges streamlined approvals for veterinary biotech products

AnimalhealthEurope, 11 Jun 2025

The association requests simplified reporting and a one-stop shop for regulatory data. They also seek exemptions from GMO rules and more flexible clinical trials.
Streamlining regulations would lower administrative costs and accelerate the delivery of innovative treatments.
Environmental groups may lose oversight if risk assessments for gene therapies are eliminated.

FEFAC Urges EU to Ease Biotech Rules for Additives

Fédération Européenne des Fabricants d'Aliments Composés, 6 Jun 2025

FEFAC requests that vitamins and amino acids from fermentation be recognized as critical chemicals. They call for a legal framework that encourages the uptake of new genetic techniques. They also seek to remove zero-tolerance rules for residual DNA in specific additives.
This would reduce legal risks for suppliers and lower dependency on Chinese imports.
Environmental advocates lose protections provided by strict zero-tolerance rules for genetically modified fragments.

Ecolab urges streamlined EU rules for biotech manufacturing

ECOLAB, 11 Jun 2025

Ecolab calls for implementing international guidelines to simplify medicine lifecycle management. They also advocate for standardized platform definitions to streamline manufacturing and regulatory approvals.
Streamlined rules would help Ecolab's customers adopt their products faster, reducing logistical costs.

Fraunhofer urges EU to bridge biotech research-to-industry financing gap

Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V., 5 Jun 2025

Fraunhofer requests targeted financial support for early-stage biotech startups to bridge the research-to-industry gap. They advocate for expanded technology infrastructures, such as pilot plants, and the creation of regulatory sandboxes. Additionally, they call for standardized sustainability metrics and a reassessment of waste regulations.
This would help the organization turn its research into marketable technologies while securing long-term funding.
Non-sustainable industries lose market share due to higher carbon taxes and reduced subsidies.

Helmholtz Association urges EU support for early-stage biotech research

Helmholtz-Gemeinschaft Deutscher Forschungszentren e.V., 11 Jun 2025

Helmholtz calls for continued support for early-stage research and scientific evidence-based decisions regarding animal research. They recommend streamlining regulatory bottlenecks in clinical trials and creating a matchmaking platform for investors.
Protecting animal research and securing infrastructure funding would safeguard Helmholtz's operational capacity and research output.
Animal welfare groups lose influence as Helmholtz advocates for the continued use of animal models.

VTT urges EU to boost biotech funding and streamline regulation

VTT Technical Research Centre of Finland Ltd, 11 Jun 2025

The organization calls for a cohesive framework aligning regulation, innovation, and industrial policies. They request increased funding for biomanufacturing infrastructure and faster market approval processes.
Enhanced funding and infrastructure would help VTT translate research into viable commercial startups.
Fossil-based plastic manufacturers face increased competition from bio-based materials reaching the market faster.

European Brain Council urges neuroscience priority in Biotech Act

European Brain Council, 11 Jun 2025

The council demands that brain health be explicitly prioritized to support the translation of research breakthroughs. They advocate for streamlining administrative processes and reducing regulatory burdens from overlapping requirements. They also stress that legislation must protect scientifically justifiable research involving animal models.
Faster regulatory pathways would allow members to bring innovative neurological treatments to patients more quickly.
Animal welfare groups lose ground as the council pushes back against restrictions on biomedical research.

German social insurers demand biotech safety and patient-first affordability

Deutsche Sozialversicherung Europavertretung, 10 Jun 2025

The DSV demands that patient health and medicine affordability take precedence over industrial policy goals. They propose adding a profitability criterion to orphan drug designations and ensuring transparent public funding leads to fair prices.
This approach protects national healthcare budgets by preventing the exploitation of funds for industrial policy.
Biotech firms lose subsidies if they fail to prove commercialization is unviable without special status.

CEPI urges EU Biotech Act to prioritise pandemic preparedness funding

Coalition for Epidemic Preparedness Innovations, 11 Jun 2025

CEPI requests a simplified, agile regulatory framework for clinical trials. They recommend allocating at least 20% of FP10 funding to health.
The proposal ensures stable funding and faster development timelines for vaccines.
Developers might lose exclusive control through mandatory tech transfer and IP sharing.

Aarhus University leads call for comprehensive EU Biotech Act

Aarhus University, 11 Jun 2025

The alliance calls for a cross-cutting Act that explicitly integrates bioeconomy-related sectors. They demand that universities be recognized as central innovation engines and biotech nurseries. The framework should ensure a seamless continuum from basic research to market deployment.
Recognition as innovation hubs would increase their access to funding and collaborative research opportunities.
Fossil-based industries would face tougher competition from subsidized and regulatory-favored bio-based products.

Biocontrol association urges EU to streamline green pesticide approvals

International Biocontrol Manufacturers' Association, 11 Jun 2025

The association wants a broad scope covering diverse agri-food biological applications. They demand a harmonized EU-wide legal definition to stimulate market demand. They also request streamlined regulatory pathways.
Streamlined rules would reduce investment payback times and foster industry growth.
Conventional chemical pesticide producers face increased competition from faster-tracked biological alternatives.

DSM-Firmenich urges EU to include food sector in Biotech Act

DSM-Firmenich, 11 Jun 2025

The company recommends including food and industrial biotechnology in the Act to support innovation. They call for a shift toward product-centric regulation for microorganisms and streamlined authorization processes. The EU should also increase research funding and venture capital access for biomanufacturing.
These changes would reduce regulatory delays and help maintain their competitive market position.
The agricultural food sector may face increased competition and higher prices for raw materials.

Dutch greenhouse growers urge faster EU biocontrol product approvals

Glastuinbouw Nederland, 6 Jun 2025

The organization advocates for a dedicated regulatory framework and a priority approval lane for biocontrol products. They suggest simplifying existing rules and establishing a specialized sustainability desk at EFSA.
Faster authorization of green alternatives would lower environmental impact and boost international competitiveness.
Traditional chemical pesticide manufacturers face increased competition from prioritized and faster-tracked green alternatives.

Pharma Deutschland seeks specific healthcare measures in EU Biotech Act

Pharma Deutschland e.V, 11 Jun 2025

The association urges a differentiated approach to biotechnology in healthcare under the wider Act. They want to streamline clinical trial authorisations and move beyond price-driven procurement logic. This targeted approach would ensure rules are adapted to the needs of biotech innovators.
This would lower development costs and protect valuable trade secrets from disclosure to competitors.
Health systems may face increased spending if drug procurement ignores lowest price criteria.

ESIP urges Biotech Act to prioritize healthcare sustainability

European Social Insurance Platform AISBL, 11 Jun 2025

Public investment in research must lead to public benefit and fair product prices. The organization demands that new regulatory pathways do not dilute evidence or safety standards. They also call for early dialogues with payers to align innovation with societal needs.
This approach would protect the financial viability and long-term sustainability of health systems.
Large multinational corporations could lose out if incentives are restricted to smaller firms.

Consultation response

Association of European Cancer Leagues, 11 Jun 2025

Both medical and technological developments have led to the increased provision of cancer medicines on the market, making it possible for cancer patients to live longer with a better quality of life. However, currently, the only way to bring innovative cell and gene therapies to patients is via a…

European Society for Paediatric Oncology demands childhood cancer focus

European Society for Paediatric Oncology, 6 Jun 2025

The organization requests targeted financial incentives and simplified regulatory pathways for academic developers. They advocate for harmonized EU quality standards to support local hospital-based manufacturing.
These changes would help academic institutions overcome financial barriers to develop authorized therapies.

German pharma group BPI calls for EU Biotech Agency

Bundesverband der Pharmazeutischen Industrie e.V., 10 Jun 2025

BPI recommends establishing a dedicated EU Biotech and Biomanufacturing Agency to manage infrastructure and funding. They also advocate for an Innovation Fund to support biotech companies from research through to manufacturing.
These measures would lower capital barriers and reduce administrative costs for pharmaceutical developers.
International suppliers will see reduced demand as Europe prioritizes local raw material production.

CNRS demands fundamental research focus in new Biotech Act

Centre National de la Recherche Scientifique, 10 Jun 2025

The CNRS wants robust support for basic research alongside better paths to the market. They recommend reinforcing European funding and creating joint academic-private laboratories.
This ensures continued funding for research while facilitating the commercialization of academic findings.
Industries relying on animal models may face disruption from shifts toward bio-inspired testing.

Consultation response

Food Fermentation Europe, 5 Jun 2025

1. Integrate food innovation as a core pillar of the Biotech Act Food biotechnology has been recognised by the European Commissions as a strategic technology under the Strategic Technologies for Europe Platform (STEP), highlighting its importance for economic resilience and innovation. To realise…

Consultation response

Pandemic Action Network, 10 Jun 2025

In our rapidly changing technological environment, we welcome the Commissions initiative to advance an EU Biotechnology Act. We urge Europes ambition to lead in biotechnology be matched by a robust, integrated approach to innovation and security, seizing a unique opportunity to emerge as a leader…

Oncology society urges putting cancer at heart of Biotech Act

European Society for Medical Oncology (ESMO), 10 Jun 2025

ESMO recommends placing cancer at the core of the legislation to accelerate drug development. They call for reduced regulatory complexity to make Europe more attractive for clinical trials.
Simpler rules would help resource-limited researchers transfer innovative cancer treatments to clinics faster.

Consultation response

Psychedelic Access and Research European Alliance, 6 Jun 2025

PAREA welcomes the Commissions ambition to strengthen the European biotech ecosystem. The Biotech Act can play a crucial role in unlocking innovation in areas that combine high public health need with persistent underinvestment - notably mental health. Mental health is not just another disease…

Consultation response

GreenLight Biosciences, 11 Jun 2025

GreenLight Biosciences is pleased to share feedback for the Biotech Act initiative in the attached document.

Bio-based industry urges EU to expand Biotech Act scope

Bio-based Industries Consortium, 11 Jun 2025

The organization wants the law to include materials, chemicals, and food production rather than just medicine. They also request simplified rules and more funding to help European companies compete globally.
Expanded scope and streamlined rules would help bio-based firms secure investments.
Fossil-based industries may face tougher competition from subsidized and faster-approved bio-based alternatives.

Cancer Patients Europe urges patient-centered focus for Biotech Act

Cancer Patients Europe, 11 Jun 2025

The organization demands that the Act focuses on patient needs and underserved communities. They advocate for equitable access to innovations and affordable cost structures across all regions. Furthermore, patient groups should be formal partners in policy governance and early-stage research.
This would ensure cancer patients receive more affordable, targeted, and effective treatments.
Commercial developers may face pressure from requirements for measurable public returns on investment.

Hospital Pharmacists Demand Central Role in Biotech Act

The European Association of Hospital Pharmacists, 11 Jun 2025

The organization calls for hospital pharmacists to be recognized as central actors in the management and delivery of advanced therapy medicinal products. They demand that new legislation includes strong transparency requirements for public funding and the development of standardized European training programs.
This would solidify their professional authority over complex therapies and secure funding for necessary hospital staffing.
Commercial biotech firms could lose control over product training and face more burdensome public disclosure rules.

Consultation response

Valneva, 11 Jun 2025

VALNEVA SE is a European biotech company developing, manufacturing and commercialising vaccines against infectious diseases with a large unmet medical need. Its affiliate Valneva Austria is a member of BIOTECH AUSTRIA, the association which represents the interests of the growing Austrian…

Austrian pharma industry urges robust biotech investment and IP framework

PHARMIG - Verband der pharmazeutischen Industrie Österreichs, 11 Jun 2025

PHARMIG advocates for a robust IP framework to provide effective R&D incentives. They seek simplified cross-border clinical trials and faster regulatory procedures for innovations.
These measures would reduce financial risks and accelerate commercialization of pharmaceutical products.
Public payers may see increased spending as health budgets are reclassified as investments.

Roche Urges Unified EU Biotech Governance to Enhance Global Competitiveness

F. Hoffmann-La Roche Ltd, 11 Jun 2025

Roche proposes streamlining clinical research through a single orchestrating body for medical authorizations. They request predictable intellectual property protections and clarity on artificial intelligence rules for pharmaceuticals. The company advocates for risk-based approaches to reduce trade burdens like product re-testing.
Unified rules and faster assessments would lower administrative costs and speed up product launches.
Environmental and chemical safety regulators may lose autonomy if pharmaceutical assessments become binding over theirs.

Amgen urges EU to streamline biotech regulatory approvals

Amgen Inc, 6 Jun 2025

Amgen requests a centralized system under the European medicines regulator to fix uncoordinated rules. They propose a faster 120-day approval process for new biotech drugs. They also want to end repetitive safety testing for imports from trusted countries.
Streamlining approvals would reduce Amgen's administrative expenses and accelerate their product launches.
European laboratories would lose business if mandatory local testing for imported drugs is removed.

GFI Europe Urges EU to Prioritize Sustainable Food Biotechnology

The Good Food Institute Europe (Belgium), 5 Jun 2025

GFI Europe calls for food biotechnology to be treated as a strategic pillar. They demand an ambitious industrial strategy involving increased public funding and improved infrastructure.
This strategy would secure more funding and faster market access for protein companies.
International competitors like the US and China may lose their advantage in attracting European biotech innovators.

INRAE urges EU to expand Biotech Act beyond healthcare

Institut national de recherche pour l’agriculture, l’alimentation et l’environnement, 6 Jun 2025

INRAE proposes including agri-food and bioeconomy sectors within the scope of the Act. They request faster marketing procedures to prevent losing economic potential to global competitors.
Modernized regulations would help the institute successfully transfer its laboratory research to industry.
The petrochemical industry stands to lose its market dominance due to proposed subsidies.

Cruelty Free Europe urges priority for non-animal biotech innovation

Cruelty Free Europe, 5 Jun 2025

The organization calls for prioritizing non-animal science as a core biotech sector. It requests a clear pathway for regulatory acceptance and improved funding for alternative testing methods.
This would accelerate the replacement of animal testing with cheaper, human-relevant alternatives.
Traditional laboratories and researchers using animal models face being phased out by modern technologies.

Wood-based panel industry urges streamlined EU biotech regulations

European Panel Federation, 10 Jun 2025

The federation requests streamlined regulations that distinguish industrial wood biotech from pharma. They also advocate for EU-level pilot funding and public procurement support.
This framework would lower compliance burdens and increase demand for wood-based products.
Fossil-based material suppliers could lose market share to bio-based wood alternatives.

Consultation response

Plants for the Future European Technology Platform, 4 Jun 2025

Biotechnology plays an vital role in shaping the future of our agrifood systems, offering a wide range of transformative solutions to meet evolving societal and environmental needs and challenges. In the next decades, Europes transition to more sustainable, resilient and competitive agrifood…

Regenerative medicine alliance urges EU to fund advanced therapies

Alliance for Regenerative Medicine, 10 Jun 2025

The group requests EU-level funding for early development and the creation of regional manufacturing hubs. They also seek more flexible regulatory pathways and reimbursement rules for specialized medical treatments.
Streamlined regulations and new funding would lower development costs and accelerate commercial entry.
Public health payers may face increased financial pressure to fund therapies with uncertain data.

Consultation response

European Biosolutions Coalition, 11 Jun 2025

EBC appreciate the opportunity to comment on the Call for Evidence for a future Biotech Act. We strongly support the development of a Biotech Act, the description of the rationale behind and the positive impact it will have for the sector and European competitiveness as described in the Call for…

Consultation response

EIT Food ivzw, 11 Jun 2025

EIT Food welcomes the call for evidence for an impact assessment on biotechnology to improve the size and competitiveness of this strategic sector in the EU while maintaining high safety standards. EIT Food emphasizes the need for the Commission to adopt a comprehensive approach to biotechnology,…

Novamont urges EU to mandate bio-based plastic targets

Novamont SpA, 11 Jun 2025

Novamont seeks mandatory bio-based targets and financial incentives for biomass usage. They also request a unique industrial classification code to distinguish bio-based products.
Mandatory targets and unique codes would secure market share and unlock new subsidies.
Traditional petrochemical companies lose out as regulations favor biomass over fossil-fuel materials.

Consultation response

BIO Deutschland, 6 Jun 2025

BIO Deutschland welcomes an EU Biotech Act. In order to leverage the power of biotechnology, the EU Biotech Act must strengthen Europes global position in the development of this strategic technology through an ambitious, cross-sectoral approach. In doing so, the EU Biotech Act should further…

Austrian Social Insurance demands patient safeguards in Biotech Act

Dachverband der österreichischen Sozialversicherung, 11 Jun 2025

They demand binding transparency for public subsidies and strict requirements for public return on investment. The organization warns against fast-track approvals based on immature evidence to protect patient safety. They also recommend early dialogues with health payers to align innovation with clinical needs.
This ensures public funding translates into affordable treatments, protecting the financial sustainability of health systems.
Biotech companies would face stricter conditions for subsidies and potentially slower authorization processes.

Consultation response

Karolinska Institutet, 11 Jun 2025

The University Alliance Stockholm Trio - Karolinska Institutet, KTH Royal Institute of Technology, and Stockholm University - appreciates the European Commissions initiative to strengthen European biotech and value this opportunity to contribute to its impact assessment on the Biotech Act. Our full…

Consultation response

Future Matters Project gGmbH, 11 Jun 2025

The Biotech Act presents a timely opportunity for the EU to support clean biotechnologies in the food sector. These technologies can make a substantial contribution to the EUs climate goals, while also creating jobs and strengthening competitiveness in a fast-growing global industry. To realise…

Consultation response

Corbion, 11 Jun 2025

Corbion welcomes the European Commissions initiative to develop a European Biotech Act and appreciates the opportunity to contribute through this call for evidence. As highlighted in the Communication on Boosting Biotechnology and Biomanufacturing in the EU, biotechnology plays a vital role in…

Consultation response

Cellular Agriculture Europe, 6 Jun 2025

Please find attached Cellular Agriculture Europe's input to the call for evidence on the European Biotech Act.

Consultation response

International Flavors & Fragrances, 11 Jun 2025

IFF supports the overall goal of the Biotech Act, to ensure that the EU makes the most of the biotech revolution for the benefit of society, the environment and the economy. This is in line with IFFs business strategy to innovate, manufacture and commercialize biobased products which improve the…

Consultation response

CCI Europe, 11 Jun 2025

Paediatric oncology is a field that has yet to reach its full potential. The creation of a legal framework for biotechs, within a truly Single Market, holds the potential to support transformative research, improve treatments, and ultimately help cure more children affected by cancer. The…

Consultation response

Associazione delle Imprese del farmaco, 11 Jun 2025

Farmindustria, in linea con EFPIA, valuta positivamente l'iniziativa della CE di definire un Biotech Act, che miri a creare un contesto favorevole a sviluppo e crescita non solo del settore biotech ma, più in generale, di tutto il settore farmaceutico. Un ecosistema in grado di adattarsi ai futuri…

Consultation response

European Flavour Association, 11 Jun 2025

EFFA represents the European Flavour industry, with a strong SME footprint and global trade. Flavourings (small dose-big impact) are food ingredients providing taste and contributing to more sustainable food systems. As a highly skilled and research-driven sector, it invests four times the EU…

Consultation response

Koppert, 21 May 2025

Koppert welcomes the European Commissions initiative to develop a comprehensive EU Biotech Act and appreciates the opportunity to contribute to its consultation process. As an entity active for more than half a century in biological crop protection and natural pollination, we believe that…

Biostimulants council urges EU to remove agricultural biotech barriers

European Biostimulants Industry Council, 11 Jun 2025

The council calls for a predictable regulatory environment that supports innovative biological solutions in agriculture. They advocate for removing internal market barriers to help farmers access essential plant biostimulants.
Streamlined regulations would improve returns on investment and prevent companies from moving innovation abroad.
European workers and the farming sector lose out as innovation and jobs move to other global regions.

Consultation response

Läkemedelsindustriföreningen, 11 Jun 2025

Lif and SwedenBIO welcomes the opportunity to be a part of the creation of the Biotech Act and strongly support the intent to foster an innovation-conducive framework to improve the competitiveness of the EU biopharmaceutical sector. At the light of the geopolitical reality the EU now faces,…

Consultation response

Association of Manufacturers and Formulators of Enzyme Products, 11 Jun 2025

AMFEP, the Association of Manufacturers and Formulators of Enzyme Products, ‎representing 90% of the EU enzyme market, welcomes the opportunity to comment on ‎the Biotech Act call for evidence. The Biotech Act is an opportunity to build on the ‎earlier recognition of enzymes as contributing to…

Malta Business Foundation urges simpler rules for biotech growth

Malta Business Foundation, 9 Jun 2025

The foundation identifies structural barriers that hinder innovation, competitiveness, and growth within the industry. They want the EU to simplify procedures and reduce time to market for Maltese businesses.
Streamlined regulations would help smaller firms overcome local barriers and achieve global biotech leadership.

Consultation response

KickCancer, 11 Jun 2025

Loncologie pédiatrique est un domaine dont le potentiel reste encore largement sous-exploité. Un véritable marché unique de la biotechnologie dans lUnion européenne constituerait le cadre idéal pour la recherche, le traitement et, à terme, la guérison du cancer de lenfant. Le marché…

Consultation response

RAND Europe (EU) AISBL, 10 Jun 2025

RAND Europe are pleased to submit evidence to this call for evidence related to the EU Biotech Act. Our submission covers six key themes: governance, workforce development, data and AI integration, access to capital, supply chain resilience, and support for physical infrastructure. We would be…

Consultation response

EIT Health, 11 Jun 2025

EIT Health welcomes the commitment to reinforce Europes competitiveness through the Biotech Act. The European biotech sector has the potential to transform health outcomes, strengthen Europes strategic autonomy, and drive competitiveness. Small start-ups and SMEs require specific policy support and…

Consultation response

Biocontrol Coalition, 11 Jun 2025

The Biocontrol Coalition argues that the current EU regulatory framework under Regulation (EC) 1107/2009 is ill-suited for biocontrol products, which are essential for sustainable agriculture. The fragmented, system built for chemistry-based products hinders innovation, delays market entry, and…

Consultation response

Breakthrough T1D, 10 Jun 2025

Breakthrough T1D (formerly JDRF) appreciates the opportunity to give comments on the Call for Evidence for an Impact Assessment on the proposed EU Biotech Act. ABOUT BREAKTHROUGH T1D As the leading global type 1 diabetes (T1D) research & advocacy organization, Breakthrough T1D helps make everyday…

Consultation response

European Institute for Wood Preservation, 10 Jun 2025

The Biotech Act should cover a broad scope of biotechnology and biomanufacturing application, notably those that are crucial for decarbonisation, sustainable construction and use of natural resources such as chemical wood protection (currently regulated under the Biocidal Products Regulation BPR…

Consultation response

Hollandbio, 10 Jun 2025

Europe worked hard to become a leader in biotech. But while the rest of the world is taking the next step, we are blocking ourselves. Innovations get stuck in outdated rules and fragmented regulations, talent moves elsewhere, and other continents capitalize on European breakthroughs. If we dont act…

Consultation response

Fondazione Telethon ETS, 11 Jun 2025

Fondazione Telethon welcomes the EC’s initiative to create an enabling environment to accelerate the transition of biotech products from laboratory to the market. As the first charity holder of a marketing authorisation (MA) in the EU for a medicinal product targeting an ultra-rare disease,…

Consultation response

Algemene vereniging van de Geneesmiddelenindustrie, 11 Jun 2025

Response of pharma.be to the Call for Evidence on the Biotech Act Pharma.be strongly supports the ambition to foster a world-class innovation environment for biotechnologies. To make the EU more attractive for researching, developing and manufacturing new technologies, simplify and safeguard a…

Consultation response

European Microbiome Innovation for Health, 11 Jun 2025

The European Microbiome Innovation for Health (EMIH) highly welcomes the initiative of the European Commission to propose a European Biotech Act. This emerging sector needs a proper regulatory framework to ensure patients safety and timely access to innovative biotechnologies, to complete the…

Consultation response

The International Aids Vaccine Initiative Inc, 11 Jun 2025

The proposal to introduce a new European Biotech Act is very welcome. Biotechnology is a real area of strength for the EU, but there are widespread concerns that the European biotech sector is not realizing its full potential, that it remains too difficult to bring new products to market, and that…

Consultation response

The European Federation for Cosmetic Ingredients AISBL, 10 Jun 2025

The European Federation for Cosmetic Ingredients welcomes the opportunity to respond to the call for evidence for an impact assessment on the European Biotech Act. PLease refer to the appended file. We remain at your disposal for further discussions and look forward to contributing to the next…

Consultation response

Phage EU, 28 May 2025

In the context of increasing antimicrobial resistance (AMR), the EU Biotech Act should recognize the role of innovative biological therapies, products and applications, such as bacteriophages, in supporting the Unions One Health objectives, strengthening health resilience, and promoting sustainable…

Consultation response

NORCE Norwegian Research Centre AS, 11 Jun 2025

The Biotechnology and Circular Economy Department at NORCE welcomes the European Commissions initiative to grow the EU biotechnology sector while upholding safety and biosecurity. Drawing on our research and Norways thematic priorities in the next framework programme for R&I priorities in…

Consultation response

European Coalition to End Animal Experiments, 11 Jun 2025

Any attempts to improve the EU biotechnology industry will also need to consider developments in the replacement of animal testing. Non-animal methods (NAMs) will be crucial to a successful biotech industry for several reasons. They can represent the very cutting edge of computer and…

Consultation response

Medtech & Pharma Platform Association, 11 Jun 2025

The Medtech & Pharma Platform Association (MPP) brings together companies from the pharmaceutical, MedTech, Diagnostics, and Tech sectors to advance combined products, i.e. solutions that integrate drugs, devices, diagnostics, and digital technologies for medical purposes. Among MPPs goals is the…

Consultation response

Pro Generika e.V., 11 Jun 2025

Konsultation zur geplanten Gesetzesinitiative EU Biotech Act (Initiative Nr. 14627) Sehr geehrte Damen und Herren, die AG Pro Biosimilars ist die Interessenvertretung der Biosimilar-Unternehmen in Deutschland. Sie steht allen Unternehmen offen, die Biosimilars entwickeln, herstellen und für die…

Consultation response

Pour Demain Europe, 11 Jun 2025

We commend the Commission for the initiative for an EU Biotech Act. This submission offers recommendations for ensuring the Act effectively integrates security and innovation to fortify Europe's strategic autonomy and global leadership in this critical field. Our response focuses on establishing a…

Consultation response

European Research Infrastructure for Translational Medicine, 11 Jun 2025

EATRIS ERIC, the European Research Infrastructure for Translational Medicine, welcomes the European Commissions initiative to develop a European Biotech Act. For the Act to succeed in boosting EU competitiveness and resilience in the healthcare domain, it must directly tackle persistent systemic…

Consultation response

Confédération des Fabricants de Levure de l'Union Européenne, 10 Jun 2025

COFALEC represents the European yeast industry as the Confederation of European yeast producers. The European yeast industry stands as the global leader in production volume, accounting for one-third of the worldwide yeast output. Established in 1959 and representing 29 production facilities across…

Consultation response

Wagralim, 4 Jun 2025

- ne pas oublier le secteur de l'industrie alimentaire qui utilise aussi les biotech alimentaires. Il y a un réel potentiel en Europe. - soutenir le scaling up est essentiel pour être compétitif - connecter les écosystèmes pour faciliter le partage des infrastructures (par exemple) - soutenir les…

Consultation response

OGM dangers, 18 May 2025

Bonjour, Les mots sont trafiqués par la COM. Elle emploie le mot de "biotechnologies ("valeur ajoutée brute de 38,1 milliards deuros en 2022") en incluant tout activité artisanale ou industrielle sur l'agroalimentaire et le médical. Ce qu'elle veut promouvoir ce sont les biotechs (en agriculture et…

Consultation response

Virtual Physiological Human Institute, 11 Jun 2025

The VPH Institute welcomes European Commissions determined efforts to accelerate biotech products, while seeking solutions to address safety and protections. As an international scientific society representing the professionals from academia, research institutes, hospitals and health technology…

Consultation response

SPHERE, 11 Jun 2025

Contribution du Groupe SPHERE Le Groupe SPHERE est un acteur industriel européen dans le domaine des emballages ménagers et professionnels. Engagé depuis plusieurs années dans la transition vers une économie circulaire et bas carbone, SPHERE investit massivement dans la recherche, le développement…

Consultation response

Alpenglow Group Limited, trading as the Centre for Long-Term Resilience, 11 Jun 2025

The Centre for Long-Term Resilience welcomes the European Commission's initiative to develop a comprehensive European Biotech Act. We are an independent, non-profit think tank with a mission to transform global resilience to extreme risks, drawing on expertise in artificial intelligence,…

Consultation response

Medac Gesellschaft für klinische Spezialpräparate m.b.H., 11 Jun 2025

medac ist ein in Deutschland ansässiges Pharmaunternehmen mit Produktionsstandorten in Deutschland und Tschechien, welches neben Medikamenten mit konventionell chemischen Herstellungsverfahren auch biotechnologisch hergestellte Arzneimittel gegen Krebs- und Autoimmunerkrankungen entwickelt,…

Consultation response

International Probiotic Association-Europe, 11 Jun 2025

IPAEurope representing companies directly engaged in the manufacture of probiotic cultures or probiotic foods, food supplements, welcome the strong political signals of support for the biosolutions sector. Fermentation technology and biosolutionssuch as enzymes, microbial food cultures, and…

Consultation response

EURAMET e.V., 11 Jun 2025

Metrology, the science of measurement, plays a crucial role in developing and improving methods of quality assurance and standardization. To promote this, several European Metrology Networks (EMNs) have been established by EURAMET. These networks are collaborative, topic-focused platforms designed…

Consultation response

Scalable Life Sciences, 11 Jun 2025

Strengthening Resilience, Strategic Independence, and Safety Through Biotech We would like to stress the importance of linking the future EU Biotech Act strongly to the need for strengthening broad societal resilience, strategic independence and safety of the European Union, especially in the…

Consultation response

Università Vita-Salute San Raffaele, 11 Jun 2025

Contribution to the Consultation on the Future European Biotech Act Università Vita-Salute San Raffaele (UniSR) strongly welcomes the European Commissions initiative to develop a comprehensive Biotech Act and appreciates the opportunity to contribute. UniSR shares the Commissions views on the five…

Consultation response

PHARMABIOTIC RESEARCH INSTITUTE, 11 Jun 2025

The Pharmabiotic Research Institute (PRI) is a non-profit European organisation dedicated to advancing regulatory science for microbiome-based innovations. PRI welcomes the initiative to establish a European Biotech Act to support innovation, scale-up, and competitiveness in the EU biotech sector.…

Consultation response

SOCIEDAD ESPAÑOLA DE FARMACIA HOSPITALARIA, 11 Jun 2025

La Sociedad Española de Farmacia Hospitalaria (SEFH), consciente de la gran relevancia que para todos los ciudadanos de la Unión Europea va a tener la futura Ley de Biotecnología por su impacto económico, científico y sanitario, agradece la posibilidad de participar en su Evaluación de Impacto, con…

Consultation response

Ogival, 11 Jun 2025

ErVimmune - Reflections on the financing of innovative European biotechnology companies Despite the existence of numerous public support schemes, innovative biotechnology companies without clinical data (yet)particularly in oncologystill struggle to secure the private funding necessary for their…

Consultation response

Association of Clinical Research Organizations, 10 Jun 2025

Thank you very much for this opportunity to respond to this Call for Evidence on the European Biotech Act. I am submitting a response on behalf of ACRO (Association of Clinical Research Organizations). The response is attached here as a Word document. Please see attachment. Respectfully submitted,…

Consultation response

Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH, 10 Jun 2025

The Austrian Agency for Health and Food Safety GmbH / Medical Market Suveillance (AGES MEA) within its remit of medicinal products and medical devices supports this legislative initiative intended to facilitate bringing innovative biotech products from lab to market. We consider this comprehensive…

Consultation response

European Hematology Association, 10 Jun 2025

The European Hematology Association (EHA) is the leading organization representing hematology professionals in Europe. As a not-for-profit, public-benefit association with over 10,000 members and an annual congress attracting around 18,000 stakeholders, EHA supports career development, research,…

Consultation response

Empowered By Us, 5 Jun 2025

Empowered By Us is an independent, patient-led initiative focused on equitable health innovation, rare disease policy, and strategic patient involvement. We welcome the opportunity to contribute to the development of the EU Biotech Act. The Biotech Act must not only support scientific excellence.…

Consultation response

European Biosafety Association, 27 May 2025

The European Biosafety Association (EBSA) is an organisation representing biosafety and biosecurity professionals, as well as those in aligned fields. It serves as a platform for specialists across Europe and beyond to share knowledge, collaborate, and promote best practices. EBSA's 600+ members…