2025/0406(COD) · Committee Report Adopted
357 submissions from 295 organizations told the European Commission what they think about this file. Here is what each of them said, in their own words.
The Commission lists 847 submissions on this file. Shown here: the 357 from organizations. Not shown, by design: submissions from private individuals, which we never publish, and anything filed since our last weekly refresh.
181 submissions from industry — companies and their trade associations — against 91 from civil society: NGOs, consumer organizations, environmental groups and trade unions. That is 2.0 industry submissions for every one from civil society.
Groupings use the respondent type each organization selected when filing. Counting submissions, not organizations — a body that filed twice is counted twice.
What the room declares
Self-declared to the EU Transparency Register (snapshot 30 Aug 2026). The cost figure sums band floors, so the true total is higher.
The file, right now
The consultation closed on 5 Aug 2026 — it ran from 17 Apr 2026.
How it got here
Also on the Commission’s pipeline for this file, with no date recorded: Initiative planned.
357 positions · showing 25
· · filed 5 Aug 2026 · source
The Association welcomes the European Biotech Act I and strongly supports the objective of making Europe the world’s most attractive location for research, development, clinical trials, manufacturing and scaling of biotech innovations. It is crucial to create a coherent, reliable and internationally competitive framework along the entire value chain.
Filed in German · English published by the European Commission
Feedback on the Proposal of the European Biotech Act I Future Affairs Consulting welcomes the proposal and, in particular, the extension of EFSA's role and strongly supports the introduction of structured pre-submission advice for applicants. This is a much needed regulatory change. However, we suggest the following changes. 1. Biosecurity should expressly include the security of the food-and-feed supply chain 2.
· · filed 5 Aug 2026 · source
The biotech sector plays a critical role in several areas of the EU economy. It is research-driven, fast-moving and requires substantial public and private investments. The Biotech Act will propose a series of measures to create an enabling environment to accelerate the transition of biotech products from laboratory to factory and to the market, while maintaining the highest safety standards for the protection of…
Filed in Italian · English published by the European Commission
· · filed 5 Aug 2026 · source
Recommendation: Establish a European Good Drug Development Practice Framework I am submitting this recommendation based on more than 13 years of experience in global drug development, clinical operations, quality assurance, regulatory readiness and strategic oversight across biotechnology and clinical research.
· · filed 5 Aug 2026 · source
EPODIN European Patient Organisation for Dysimmune Inflammatory Neuropathies welcomes the European Commission's proposal for an EU Biotech Act as a timely and ambitious initiative to strengthen Europe's biotechnology ecosystem, enhance its global competitiveness and ensure that scientific excellence translates into faster development, availability and equitable access to innovative medicines for all European…
Pharma Deutschland welcomes the European Commission's proposal for a European Biotech Act as an important step towards strengthening Europe's competitiveness, resilience and innovation capacity in biotechnology and biomanufacturing. The proposal addresses several key barriers to innovation by promoting faster clinical development, regulatory cooperation, digitalisation and strategic investment.
InnovProtein EU Alliance Contribution to the Call for Evidence on the European Biotech Act (COM (2025) 1022) I. Introduction The InnovProtein EU Alliance, represented by the European Algae Biomass Association (EABA) and the International Platform of Insects for Food and Feed (IPIFF) , welcomes the European Biotech Act and support the Commission's objective of strengthening the Union's biotechnology and…
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
Fresenius welcomes the European Commission's proposal for a Biotech Act as an important step towards strengthening Europe's biotechnology and biomanufacturing ecosystem. The proposal rightly recognises biosimilars as a strategic biotechnology industry.
Viridian Therapeutics welcomes the European Biotech Act as an opportunity to strengthen Europe's attractiveness for biotechnology investment and support timely patient access to innovative therapies. Europe's ambition to become a leading biotech scale-up region depends on being not only a place where companies conduct science, but also where innovation is launched and scaled.
· · filed 5 Aug 2026 · source
Anticancer Fund welcomes the proposed Biotech Act and particularly the need to simplify and streamline the Clinical Trials Regulation. Being strong supporters of resolution WHA75.8 (2022) on strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, we encourage the consideration of WHOs Global Action Plan for clinical trial ecosystem…
· · filed 5 Aug 2026 · source
Anticancer Fund welcomes the proposed Biotech Act and particularly the need to simplify and streamline the Clinical Trials Regulation. Being strong supporters of resolution WHA75.8 (2022) on strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, we encourage the consideration of WHOs Global Action Plan for clinical trial ecosystem…
· · filed 5 Aug 2026 · source
Europes competitiveness has taken a serious hit in the recent years, particularly in biotechnology. The EU Biotech Act I is a positive step towards strengthening the European biotechnology ecosystem with measures to accelerate clinical trials, reduce regulatory complexity and incentiv-ise innovation in Europe all improving patient access to best-in-class medicines.
August 5, 2026 European Biotech Act I - Regulation COM(2025) 1022 FUJIFILM Position and Policy Recommendations FUJIFILM welcomes the opportunity to provide comments on the Proposal for the European Biotech Act I. We support the European Union’s objective of strengthening biotechnology and biomanufacturing competitiveness, accelerating innovation, and reinforcing Europe’s resilience in health biotechnology.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
EuropaBio represents the European biotechnology industry, including small and medium-sized enterprises, startups, scale-ups, established companies and European national and regional biotech associations. EuropaBio supports the objectives of the European Biotech Act and sets out chapter-by-chapter recommendations in the attached paper. Some of the main positions are as follows.
Please the file attached for Applied Microbiology International's member response to the proposed amendments to the EU Directive on the Deliberate Release into the Environment of Genetically Modified Microorganisms, as part of the EU Biotech Act consultation.
Farmindustria, in line with EFPIA, welcomes the Commission’s proposal to create a favourable environment for the development and growth of the biotech sector and, more generally, of the entire pharmaceutical sector. It is a priority to foster an ecosystem that can adapt to future scientific and technological advancements, strengthening the EU’s competitiveness and sustainability.
Filed in Italian · English published by the European Commission
Healthtech Finland welcomes the opportunity to provide feedback on the proposal for the Biotech Act (I). Healthtech Finland supports the Act, and its aims to strengthen the EU health biotechnology ecosystem, support innovation, and enhance European competitiveness.
The Pharmabiotic Research Institute (PRI) welcomes the European Commission's proposal for a European Biotech Act. The proposal represents a timely and important opportunity to strengthen Europe's biotechnology ecosystem by improving competitiveness, fostering innovation, facilitating investment and enhancing regulatory efficiency while maintaining the Union's high standards of public health, food safety…
· · filed 5 Aug 2026 · source
Pharma Industry Finland strongly supports the objectives of the proposed Biotech Act and recognizes its potential to strengthen the EUs competitiveness, attract investment, expand clinical research activity and accelerate patients access to innovative therapies. The Biotech Act offers an opportunity to reinforce Europes position as a competitive location for life sciences.
Stand: 08/2026 Stellungnahme – European Biotech Act I Der Vorschlag für den European Biotech Act I durch die Kommission, der unter anderem die verstärkte Nutzung tierversuchsfreier Methoden befürwortet, stellt ein großes, komplexes und multidimensionales Vorhaben dar.
Filed in German · English published by the European Commission
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
Novartis welcomes the Biotech Act as a concrete step towards strengthening Europes life sciences ecosystem. By promoting simplification, regulatory coherence, reduced administrative burden and a stronger IP framework, the Act can support innovation and enhance Europes attractiveness for research, development, manufacturing and investment. To maximise its impact, Novartis highlights three priorities. 1.
The BioMed Alliance welcomes the European Commissions initiative to develop a European Biotech Act as an important opportunity to strengthen Europes biotechnology ecosystem, enhance its global competitiveness and accelerate the translation of scientific innovation into solutions that benefit society.
Please find attached the full text of comments, which is summarised below. The Right of Animals is Sweden’s leading animal rights and welfare organisation and wishes to comment on the proposed Biotech Act. The following are the most important pieces of animal law: 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…
Filed in Swedish · English published by the European Commission
The ANRS MIE welcomes the proposed Biotech Act, and particularly the introduction of an accelerated procedure for multinational clinical trials during public health emergencies, which is highly relevant. Such a measure is essential to allow the rapid deployment of multi-national coordinated clinical trials in response to an epidemic or pandemic.
Hollandbio, the Dutch biotech association, welcomes the ambition to strengthen biotech as one of Europes key technologies for health, sustainability, resilience and economic prosperity. More than ever, global challenges and geopolitics underline biotechs strategic importance.
EAHP Opinion on the Biotech Act On 16 December 2025, the European Commission published its proposal for a Biotech Act. The European AssociaAon of Hospital Pharmacists (EAHP) acknowledges the proposal as a step forward to support innovaAve biotechnologies going from scienAfic discoveries to new products more swiKly in the healthcare sector.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
· · filed 4 Aug 2026 · source
The European Biotech Act represents an opportunity to position biotechnology as a strategic enabling industry for EUs competitiveness, sustainability and economic security. This ambition is consistent with both the Draghi report, and the Commissions Competitiveness Compass which identifies simplification, innovation and frontier technologies, including biotech, as core drivers of EU competitiveness.
The Centre for Long-Term Resilience (CLTR) welcomes both the European Commission's initiative to develop a comprehensive European Biotech Act, and many of the amendments to the draft text tabled by the joint SANT and ITRE committees.
· · filed 4 Aug 2026 · source
EPTRI supports the proposed European Biotech Act as a strategic opportunity to strengthen Europe's biotechnology ecosystem by translating scientific excellence into innovative healthcare products while promoting equitable access to innovation. However, the current draft does not yet fully recognise paediatric health and research as strategic priorities for biotechnology innovation.
The European Cancer Organisation welcomes the European Commissions proposal for a Biotech Act. The Act shows strong potential in supporting an environment in Europe in which research and innovation in fields such as new cancer treatments can flourish. The Act also identifies a number of barriers to the adoption of improved forms of treatment, with sensible proposals for how these can be alleviated.
Cellular Agriculture Europe welcomes the publication of the Commissions proposal for a European Biotech Act. The proposal is an important first step in strengthening Europes biotechnology and biomanufacturing ecosystem, improving regulatory predictability, and reducing delays for innovative companies.
The European Animal Research Association (EARA) represents over 230 member organisations in 25 European countries and 21 others and promotes openness and transparency in animal research. EARA welcomes the European Biotech Act Part I and its ambition to strengthen Europe's health biotechnology pathway from scientific discovery to clinical application, manufacturing and patient access.
· · filed 4 Aug 2026 · source
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. We connect European stakeholders to ignite change and bridge the policy gaps in allergy and airways diseases so that patients live uncompromised lives, have the right and access to the best quality care and a…
· · filed 4 Aug 2026 · source
The German Environment Agency has the following comments on the proposed amendments to Regulation EU 2019/6 and the corresponding annex II due to the Biotech Act: i) Art. 136a, regulatory sandbox - The concept of the regulatory sandbox is complex.
IPEC Europe welcomes the objectives of the proposed Biotech Act, particularly efforts to strengthen the resilience and strategic autonomy of the EU biotechnology ecosystem. However, the proposal does not explicitly recognise the essential role of pharmaceutical excipients in biotechnology value chains.
· · filed 4 Aug 2026 · source
AstraZeneca welcomes the Biotech Act as a timely and important initiative to strengthen EUs regulatory framework for attracting investments in advanced medical R&D through improving clinical trial conduct and innovation incentives. More ambition is essential to overturn the decade-long decline in EUs share in commercial clinical trials and its erosion of intellectual property rights by the NPL.
The European Algae Biomass Association (EABA) welcomes the European Biotech Act and supports the Commission's objective of strengthening Europe's biotechnology and biomanufacturing ecosystem, reducing regulatory complexity, accelerating innovation and enhancing competitiveness.
MedTech Europe welcomes the opportunity to provide feedback on the published proposal for a Biotech Act I, which aims to strengthen the EU health biotechnology ecosystem, support innovation, and enhance Europes competitiveness. Medical technologies play a central role in Europes biotechnology landscape.
· · filed 4 Aug 2026 · source
Takeda welcomes the European Commissions proposal for a European Biotech Act and supports its overall ambition to strengthen Europes biotechnology and life sciences ecosystem. The Biotech Act is a positive and necessary step to reinforce Europes position in innovative biotechnologybased medicines.
· · filed 4 Aug 2026 · source
DECHEMA welcomes the EU initiative to support and accelerate the path from the laboratory to marketed biotech products by removing obstacles and creating a more enabling environment. The EU Biotech Act I is considered an important step, particularly through the harmonisation and streamlining of regulatory and bureaucratic procedures.
· · filed 4 Aug 2026 · source
Europe has a unique opportunity to make biotechnology a driver for both innovation and more modern health research. The future European Biotech Act I should therefore focus not only on strengthening Europe’s competitiveness, but also on promoting those technologies that can deliver more human-relevant research while reducing reliance on animal testing.
Filed in Danish · English published by the European Commission
· · filed 3 Aug 2026 · source
Regeneron is a leading biotechnology company that develops medicines for people with serious diseases, and has substantial clinical trial and regulatory activity in the EU. The Biotech Act's CTR and SPC proposals address real barriers to that work, but impact depends on consistent implementation across Member States and alignment of the EHDS Regulation secondary use provisions with CTR/EMA Policy 0070.
Dear Sir/Madam, Enclosed you will find the contribution of the Biosimilar medicines group, a Medicines for Europe sector group to the European Commissions call for feedback on the proposed European Biotech Act I (Health). We remain at disposal should you need any clarification. Kind regards
I am Ingrid Klingmann, MD, PhD, Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP, EU Transparency Register No 620464443740-12), Belgium, and Co-Chair of the EU-X-CT Initiative. The EU-X-CT Initiative has been established in 2022 to help enable cross-border access to clinical trials for patients when there is no option for them to join a clinical trial in their own country, and as the…
IPIFF Position Paper Response to the European Commission's Open Call for Consultation on the European Biotech Act International Platform of Insects for Food and Feed (IPIFF) Date: August 2026 Executive Summary IPIFF, the International Platform of Insects for Food and Feed, warmly welcomes the European Commission's initiative to develop a European Biotech Act as announced in the 2024-2029 Political Guidelines.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
· · filed 3 Aug 2026 · source
Cancer Patients Voice is an umbrella organization in the Czech Republic for patients with all types of cancer. From our patients experiences, we know full well that clinical trials can offer them access to innovative treatments when no other effective option is available. For some patients, access to a clinical trial can be a matter of life and death.
ESPP welcomes that the Call for Evidence for the BioTech 2 consultation of 10th June identified fertilisers as an area for action, citing creation of lead markets and simplification of legislation. This is coherent with the EU Fertiliser Action Plan (19th May 2026) which states that the Biotech Act will prepare measures to create lead markets for bio-based fertilising products.
The European Hematology Association (EHA) is the leading representative of hematology and hematology professionals in Europe. We are a not-for-profit organization with over 12,000 members. EHA develops and harmonises hematology education, produces clinical practice guidelines, supports career development and research, and advocates for affordable and equitable access to innovative therapies for patients with…
AxelOne fully supports the European Commissions proposal for the European Biotech Act as an important step towards strengthening biotechnology and biomanufacturing as strategic capabilities for Europe. AxelOne is the French collaborative innovation platform in the Chemistry and Environment sector created in 2011 and dedicated to smart processes and innovative materials.
· · filed 31 Jul 2026 · source
The Commissions proposal for a European Biotech Act I 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, 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.
1. An unbalanced text to the detriment of public health and patients’ interests. Strengthening the competitiveness of the health biotechnology sector appears to be the sole objective of the Regulation. There is a need for clear prioritisation of public health objectives.
Filed in French · English published by the European Commission
· · filed 31 Jul 2026 · source
Genetically modified microorganisms (GMMs) are a key component of modern biotechnology. They can be used both as production organisms in contained systems or as products in their own right. Examples include industrial processes, in agriculture, in the food industry, in environmental biotechnology and the recovery of raw materials.
· · filed 31 Jul 2026 · source
DIB welcomes the European Commissions proposal for the European Biotech Act I as an important step towards strengthening biotechnology and biomanufacturing as strategic capabilities for Europe. Biotechnology contributes to innovations in healthcare, food and feed innovation, agricultural production, the bioeconomy, industrial manufacturing, resilience and security.
Sanofi is one of the world's leading healthcare companies and the largest EU-headquartered pharmaceutical company, with deep and long-standing roots across the European research, clinical development and manufacturing.
Eurogroup for Animals welcomes the Commissions proposal for a European Biotech Act, considering it a timely opportunity to place human-relevant, non-animal biotechnologies at the centre of the EUs biotechnology strategy. By doing so, the Biotech Act will better align biotechnology policy with European values, scientific excellence, societal expectations and public health priorities.
GAIA Global Action in the Interest of Animals welcomes the European Commissions ambition to strengthen the European Unions competitiveness, innovation capacity and strategic autonomy in the biotechnology sector. However, the future Biotech Act should go beyond accelerating the transition of discoveries from the laboratory to the market.
EuropaBio welcomes the introduction of targeted improvements in the Directive. It supports the objective of ensuring a high level of safety for human health and the environment while stimulating and advancing innovation, competitiveness and legal certainty.
AseBio welcomes the Proposal for a Directive COM(2025) 1031 final, amending Directives 2001/18/EC and 2010/53/EU, as a necessary first step to adapt the regulatory framework for genetically modified microorganisms (GMMs) to scientific and technological progress and to current biotechnology applications.
· · filed 31 Jul 2026 · source
31 July 2026 Submitted electronically via Have Your Say Feedback on public consultation by the European Commissions on Biotech Act I and the proposal for amending Directive 2001/18/EC for placing GMMs on the market As an independent regulatory professional, I welcome the European Commissions (EC) Biotech Act I and the proposal for amending Directive 2001/18/EC to enable placing on the market of genetically modified…
PHARMIG, the Austrian Pharmaceutical Industry Association, welcomes in principle the European Commission’s proposal on the European Biotech Act I (Proposal for a Regulation of the European Parliament and of the Council establishing a framework of measures for strengthening biotechnology and biomanufacturing in the Union, in particular in the field of health, and amending Regulations (EC) No 178/2002, (EC) No…
Filed in German · English published by the European Commission
· · filed 31 Jul 2026 · source
Clinical trials may offer patients access to innovative treatments when no other effective option is available. For some patients, access to a clinical trial can be a matter of life or death. However, clinical trials are often opened only in selected EU Member States. Patients living in other countries may therefore be denied access to a potentially life-saving treatment simply because of where they live.
AseBio welcomes the European Commissions proposal for a European Biotechnology Act and supports its objective of strengthening Europes biotechnology and biomanufacturing sectors. However, several provisions should be clarified and harmonised to ensure effective implementation, legal certainty and global competitiveness.
As part of the EU legislative process for an EU Biotech Act I, Regulation (EU) No. 536/2014 on clinical trials on medicinal products is to be amended to improve the framework for clinical trials in Europe. The European Commissions proposal (Proposed Regulation COM(2025)1022 of December 16, 2025) aims to shorten approval timelines, promote cross-border cooperation, and improve procedural efficiency.
· · filed 30 Jul 2026 · source
The Biotech Acts goals of simplifying procedures, boosting EU competitiveness, and supporting innovation are welcome. However, the development, approval and availability of biotechnological medicines, particularly for rare disease (RD) patients and other vulnerable groups, seem not fully considered.
With over 160 years of experience, Bayer is a life science company and a global leader in healthcare, agriculture and nutrition. Driven by our mission,Health for all, Hunger for none, we harness the power of science to unlock new possibilities that enhance life while serving the most essential human needs.
The European Institute for Animal Law & Policy welcomes the opportunity to provide feedback on the proposal for a Regulation on establishing framework of measures for strengthening the Unions biotechnology and biomanufacturing sectors, particularly in the area of health (European Biotech Act) (2025/0406 (COD)). Please see our comment attached.
· · filed 29 Jul 2026 · source
Clinical trials may offer patients access to innovative treatments when no other effective option is available. For some patients, access to a clinical trial can be a matter of life or death. However, clinical trials are often opened only in selected EU Member States. Patients living in other countries may therefore be denied access to a potentially life-saving treatment simply because of where they live.
Cancer Patients Europe (CPE) welcomes the European Commission's proposal for a European Biotech Act and supports its ambition to strengthen Europe's biotechnology and biomanufacturing ecosystem. Biotechnology has enormous potential to improve disease prevention, diagnosis and treatment, particularly through advanced diagnostics, innovative therapies and clinical research.
· · filed 29 Jul 2026 · source
Cancer Patients Europe (CPE) response to the European Commission consultation on the proposed Directive accompanying the European Biotech Act CPE welcomes the European Commission's proposed Directive amending Directives 2001/18/EC and 2010/53/EU as part of the implementation of the European Biotech Act.
· · filed 28 Jul 2026 · source
For the 34 million people living with diabetes in the EU, biotechnology has the potential to transform prevention, treatment and long-term care. Advances such as next-generation insulins, cell and gene-based therapies and other biotechnology-derived medicines could significantly improve health outcomes and quality of life. Europe already has the scientific excellence to lead this transformation.
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), representing predominantly small- and mid-sized innovative pharmaceutical companies, views Part I of the European Commissions proposed European Biotech Act as a timely and promising initiative.
Servier, an independent international pharmaceutical group focusing on oncology, neurology and cardio-metabolic diseases, welcomes this public consultation. Our unique governance as an independent company governed by a non-profit Foundation allows us to maintain a long-term vision focused solely on therapeutic progress and patient needs.
701 Carlson Parkway, Suite 220 Minnetonka, MN 55305 July 25, 2026 Submitted electronically via Have Your Say Regarding: 1462 Biotech Act Subject: Feedback on public consultation by the European Commission’s (DG Sante) on Biotech Act I and the proposal for amending Directive 2001/18/EC for placing GMMs on the market I’m writing as a senior member of the team at Pivot Bio. Based in Minnesota, USA.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
The European Social Insurance Platform (ESIP) and the Medicine Evaluation Committee (MEDEV) support the objective of strengthening Europe's biotechnology and biomanufacturing ecosystem through the EU Biotech Act. Importantly, industrial policy measures must remain compatible with timely patient access, affordable medicines, robust clinical evidence and the long-term sustainability of healthcare systems.
Pro Anima Scientific Committee welcomes the European Commissions initiative to develop a European Biotech Act and strongly supports its ambition to strengthen the EUs position as a global biotechnology leader by accelerating innovation and translating scientific excellence into societal and economic value.
· · filed 22 Jul 2026 · source
EFPIA welcomes the European Commission's initiative to develop the Biotech Act and strongly supports its objective of strengthening Europe's life sciences ecosystem. Europe has world-class scientific capabilities and a strong industrial base but continues to face challenges in translating research excellence into investment, clinical development, manufacturing and patient access.
Vaccines Europe (VE) concurs with the responses submitted by EFPIA on proposed Biotech Act, while raising implications specific for vaccines development and manufacturing. Sitting at intersection of public health, innovation, and industrial policy, vaccines are one of the most advanced and impactful applications of biotechnology.
· · filed 22 Jul 2026 · source
EFPIA welcomes the European Commission's initiative to develop the Biotech Act and strongly supports its objective of strengthening Europe's life sciences ecosystem. Europe has world-class scientific capabilities and a strong industrial base but continues to face challenges in translating research excellence into investment, clinical development, manufacturing and patient access.
Recognises the strategic importance of non-animal biotechnologies for strengthening Europe's biotechnology ecosystem and advancing a more innovative, human-relevant and competitive life sciences sector; underlines that these technologies are already contributing to progress in disease modelling, medicinal product development, safety assessment and personalised medicine, while supporting the gradual transition away…
Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates zur Schaffung eines Rahmens für Maßnahmen zur Stärkung der Biotechnologie und der Bioproduktion in der Union, insbesondere im Bereich der Gesundheit, und zur Änderung der Verordnungen (EG) Nr. 178/2002, (EG) Nr. 1394/2007, (EU) Nr.
Filed in German · English published by the European Commission
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
Corbion welcomes the European Commissions proposal for the European Biotech Act I and particularly supports the measures aimed at optimising approval processes under Regulation (EC) No 178/2002. Biotechnology is essential to strengthening EU competitiveness, resilience, and strategic autonomy, and efficient regulatory pathways are critical to ensuring timely market access for innovative biotech solutions.
The proposed Biotech Act recognises biotechnology as a strategic driver of EU competitiveness and economic security. CropLife Europe welcomes the provisions linked to the General Food Law that expand EFSA pre-submission advice to cover scientific aspects, fostering more effective dialogue and greater regulatory clarity for applicants.
The Japan Business Council in Europe (JBCE) welcomes the opportunity to present its views on the European Commission's proposal for a European Biotech Act. JBCE supports the proposal's ambitious and innovation-oriented framework for the competitiveness of the EU's biomanufacturing sector, in particular its commitment to rewarding innovation, as well as its measures to accelerate and simplify clinical trials, foster…
The Life Science Manufacturers Association (LSMA) represents the companies that supply the tools, equipment, and technologies enabling Europes biotech and biomanufacturing ecosystem. LSMA welcomes the Biotech Act I and its ambition to strengthen Europes biotechnology ecosystem, enhance competitiveness, and increase manufacturing capacity within the EU.
Europe has world class scientific excellence in biotech and healthcare, yet it underperforms in translating this strength into globally competitive companies, industrial capacity and patient access. Public capital is retreating from biotech and healthcare faster than from the wider PE/VC market, while institutional investors remain underrepresented in the sector, limiting long-term, stable capital.
· · filed 14 Jul 2026 · source
EHPM Feedback on the Biotech Act The European Federation of Associations of Health Product Manufacturers, hereinafter EHPM, EU stakeholder registered on the EU Transparency Register (No. 65512466920-96) is delighted to submit comments in the context of the Biotech Act.
14 July 2026 Biotech Act I IBMA, the International Biocontrol Manufacturers Association Feedback IBMA, the association representing biological control manufacturers in Europe and globally since 1995, with over 200 members, welcomes the European Commission's initiative to develop a European Biotech Act I.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
· · filed 13 Jul 2026 · source
Farmaindustria appreciates the Regulation for its potential to strengthen the EU’s competitiveness, strategic autonomy and innovation capacity, although it could be more ambitious in the face of increasing global competition and investment pressure from other regions.
Filed in Spanish · English published by the European Commission
The Helmholtz Association of German Research Centres welcomes the European Commission's proposal for a European Biotech Act as an important step towards strengthening Europe's biotechnology ecosystem, research and innovation capacity, competitiveness and resilience.
The Federation of Polish Entrepreneurs (FPP) welcomes the European Commissions initiative to establish a European Biotech Act. FPP supports the overall direction of the proposal, but 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.
Plasma Protein Therapeutics Association (PPTA) is pleased to share feedback for the Biotech Act in the attached document. The plasma-derived medicinal products industry represents a significant and established component of Europes biotechnology ecosystem, with a substantial manufacturing footprint and contribution to employment and economic activity.
We support the development of a strong Biotech Act that strengthens Europe’s competitiveness, supports industrial scaling, promotes sustainable bio-based innovation, and simplifies regulation. The Biotech Act should clearly include the agri-food sector, recognise advanced fermentation and existing bio-based industrial capacities, accelerate regulatory procedures while maintaining high safety standards, enable…
Filed in French · English published by the European Commission
The European Microbiome Innovation for Health (EMIH) welcomes the European Commission's proposal for a European Biotech Act and is pleased to submit the attached contribution. EMIH fully supports the ambition of the Act to strengthen Europe's biotechnology ecosystem and proposes a number of targeted recommendations to ensure that microbiome-based health innovation is fully considered during the implementation of the…
Biocodex welcomes the European Commission's initiative to establish a dedicated EU Biotech Act and fully supports its objective of strengthening Europe's biotechnology ecosystem. While the proposal is an important step forward, we believe its impact could be enhanced by ensuring that the framework also addresses the needs of mid-sized innovative companies alongside start-ups and SMEs.
The European Society for Medical Oncology (ESMO) - a professional society representing over 50,000 members globally - welcomes the Commissions proposal for a European Biotech Act as a timely initiative to strengthen Europes attractiveness for biomedical research and innovation, including in oncology.
BEUC welcomes this initiative and recognises the importance of strengthening the biotechnology sector to deliver innovative products and improve access for patients and consumers. However, such efforts must be accompanied by strong safeguards to ensure that innovation serves the public interest.
ACREDITAR Feedback European Biotech Act I: Introduction text Childhood Cancer International Europe (CCI Europe) represents childhood cancer organisations, including parents and survivors groups, across Europe. ACREDITAR Associação de Pais e Amigos de Crianças com Cancro is one of the founding members of Childhood Cancer International (CCI).
The European Association of Nuclear Medicine (EANM) strongly supports the objectives of the Act and welcomes the European Commissions aims to strengthen Europes biotechnology ecosystem, improve competitiveness and advance innovation.
Biotechnology as a Strategic Pillar for European Sovereignty, Competitiveness, and Resilience: Europe faces the existential task of shaping its future, and biotechnology sits at the very heart of that challenge.
INSERM fully supports the European Commission’s proposal to strengthen the biotechnology and biomanufacturing sectors in the field of health. The Institute welcomes in particular the Commission’s commitment to tackle the fragmentation and regulatory complexity that are currently holding back the development of this sector in Europe.
Filed in French · English published by the European Commission
EFFCA welcomes the Commissions initiative to develop a more tailored framework for genetically modified micro-organisms (GMMs), recognising that the current plant-based GMO legislation is not suited to microorganisms. It supports a proportionate, science-based approach that maintains high safety standards while reflecting the specific characteristics of microorganisms, including food and fermentation cultures.
The EU Biotech Act is an important opportunity to boost Europes standing in the biotechnology sector. The accompanying adjustments to existing regulations proposed by the directive COM(2025)1031 are much needed to contextualise the difference between low-risk GMM and, e.g., plant GMO.
· · filed 12 Jun 2026 · source
The proposed European Biotech Act rightly places strong emphasis on accelerating clinical development, improving regulatory efficiency, and strengthening Europes competitiveness in biotechnology. One additional consideration may merit greater attention during the legislative process: the role of patient identification in determining the success of biotechnology innovation.
DI Biosolutions welcomes the European Commissions proposal COM(2025) 1031 as an important step towards a more proportionate, risk-based and innovation-friendly regulatory framework for genetically modified micro-organisms (GMMs) in the European Union. GMMs play a critical role across a wide range of sectors, including food and agriculture, industrial biotech and environmental applications.
· · filed 11 Jun 2026 · source
The Government of the Canary Islands welcomes the proposal for a directive amending Directives 2001/18/EC and 2010/53/EU, adapting the European framework to biotechnological developments and encouraging innovation, provided that simplification preserves public health, patient safety, biosafety and the environment.
Filed in Spanish · English published by the European Commission
· · filed 11 Jun 2026 · source
SIOP Europe welcomes the proposed Biotech Act I as an important signal of the European Unions commitment to strengthening innovation in health. This is particularly important in Paediatric Oncology, where innovation remains critically insufficient.
· · filed 10 Jun 2026 · source
The Marseille Immunology Biocluster (MIB) welcomes the European Biotech Act as a pivotal step in closing Europe's biotech developpement and commercialisation gap. Bioclusters are structurally unique and cost-efficient pipeline for strenghtening our European Industry: by de-risking early-stage innovation at the public-private interface, they channel a disproportionate share of high-value therapeutic assets toward…
Synadiet welcomes the European Commissions presentation of the Biotech Act I and the ongoing work towards the Biotech Act II. Strengthening Europes biotechnology sector is essential to maintaining global competitiveness and securing Europes strategic autonomy in innovation. Achieving this objective requires a regulatory framework that actively supports innovation.
Position paper by Prescrire about Biotech act regulation proposal Proposal for a regulation establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health (COM(2025) 1022 final – 2025/0406(COD)) 9 June 2026 General comment With this proposed Biotech Act regulation, the European Commission aims to strengthen the competitiveness of the…
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
Novonesis welcomes the European Commission proposal COM(2025) 1031 which is a step towards a more proportionate and risk-based application of EU GMO legislation. It is positive that the proposal takes steps towards a lighter regime for genetically modified microorganisms (GMMs) with a demonstrably low-risk profile.
EFFA welcomes the opportunity to comment on the European Biotech Act. We warmly welcome the EuropeanCommissions initiative to modernise the biotechnology and food regulatory environment through the EUBiotechAct. The proposal represents a solid step toward a more innovation friendly, science based, and efficient system that can support sustainable bio based solutions for food ingredients and flavour developments.
The Spanish Federation of Children’s Cancer Families (FEFCI) is a non-profit organisation founded in 1990 by parents of children and adolescents with cancer and comprising 23 parents’ associations in Spain. Our main objective is to ensure that all children and adolescents with cancer in Spain have the greatest opportunities for diagnosis, treatment and cure, and receive comprehensive care that supports their quality…
Filed in Spanish · English published by the European Commission
KickCancer is a Belgian foundation that funds paediatric cancer research, empowers patients and drives innovation to cure every child and young adult. Over the last decades, medicine development for specific childhood cancer indications, First-in-Child (FiC), has significantly stalled compared to adult anticancer medicines, even in contrast to rare types of adult cancer.
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 Commissions Biotech Act Proposal as an important initiative to strengthen Europes clinical research ecosystem, improve clinical trial authorisation and conduct, and reinforce preparedness for future public…
Childhood Cancer International Europe (CCI Europe) represents childhood cancer organisations, including parents and survivors groups, across Europe. Over the last decades, medicine development for specific childhood cancer indications, First-in-Child (FiC), has significantly stalled compared to adult anticancer medicines, even in contrast to rare types of adult cancer.
BPI welcomes the European Commissions initiative, the EU Biotech Act I, which represents a crucial step towards strengthening Europes biopharmaceutical sector. It particularly supports measures to expand biopharmaceutical manufacturing capacity, reduce dependencies on critical raw materials, accelerate approval procedures, streamline regulatory pathways for advanced therapy medicinal products (ATMPs), and promote…
· · filed 28 May 2026 · source
EUCROF represents more than 400 Clinical Research Organisations (CROs) across more than 20 countries and brings together a broad network of clinical research organizations. The European Commissions proposal for a Biotech Act is an important and welcome step forward and sets a positive signal at a time of intense global competition. EUCROF urges its rapid adoption.
The European Biosafety Association (EBSA) welcomes the European Biotech Act I as a significant initiative towards strengthening the biotechnology ecosystem in Europe, taking note of its focus on health biotechnology as an initialstep.
AnimalhealthEurope, the association representing the manufacturers of veterinary medicines, vaccines and other animal health products, welcomes the Commission Proposal on a European Biotech Act. AnimalhealthEuropes membership covers 90% of the European market for animal health products.
PAREA welcomes the development of a European Biotech Act and strongly supports its goals. However, the initiative should explicitly address one of the clearest examples of market and regulatory failure in European health innovation: mental health. Mental health conditions represent one of the largest and most persistent unmet needs in Europe.
· · filed 19 May 2026 · source
As Founder of BIOAMA Biotecnologías Aplicadas al Medio Ambiente, I strongly welcome the European Unions efforts to strengthen the biotechnology ecosystem through the upcoming Biotech Act. From our experience developing environmental biotechnology solutions focused on sludge remediation, wastewater treatment and circular bioeconomy strategies, we believe Europe has a unique opportunity to become the global leader in…
Evonik is a global specialty chemicals company that goes beyond the boundaries of chemistry by combining innovative strength with leading technological expertise. Through tailor made products and solutions, Evonik creates decisive competitive advantages for its customers and contributes to improving quality of life - across markets and every day. Evonik is actively driving the green transformation of industry.
WePlanet supports the European Commission's initiative to establish a European Biotech Act, which is designed to strengthen the EU's biotechnology and biomanufacturing sectors. While we welcome the proposed Biotech Act I, however, given that the primary focus is on health biotechnology, we are concerned that novel foods are excluded from the regulatory sandbox scheme on the grounds of consumer, ethical and cultural…
· · filed 11 May 2026 · source
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 Commissions Biotech Act Proposal as an important initiative to strengthen Europes clinical research ecosystem, improve clinical trial authorisation and conduct, and reinforce preparedness for future public…
The European Biotech Act is a timely and important initiative to strengthen the Unions competitiveness, technological sovereignty and industrial capacity in biotechnology. While the strong focus on health biotechnology is understandable, the proposal insufficiently reflects the strategic importance of agricultural biotechnology, notwithstanding the Acts repeated references to food systems, sustainability, climate…
FoodDrinkEurope welcomes the European Commissions proposal for a European Biotech Act aimed at strengthening the Unions biotechnology and biomanufacturing ecosystem and facilitating the translation of innovation into marketable products.
· · filed 30 Apr 2026 · source
The Government of the Canary Islands welcomes the proposal for a regulation. However, the following considerations are necessary: (1) it is essential to ensure the active involvement of regional health services and public hospitals in the governance, implementation and monitoring of the Regulation.
Filed in Spanish · English published by the European Commission
· · filed 28 Apr 2026 · source
The package of proposals aims to speed up market access and reduce administrative burdens, while maintaining high safety standards for human health and the environment. Particular attention will be paid to the modernisation of the regulation of genetically modified micro-organisms (GMM), introducing a low-risk category and time-limited marketing authorisations.
Filed in Hungarian · English published by the European Commission
· · filed 18 Apr 2026 · source
Feedback on the proposed European Biotech Act The proposed European Biotech Act addresses key barriers that limit the EUs ability to translate strong life-science research into timely patient benefit and sustainable economic value. Its focus on regulatory predictability, clinical trial efficiency, digitalisation, strategic project support, and improved conditions for SMEs and scale-ups is well placed.
Resulting from continuous and substantial investment in innovation, specialty food ingredients allow food manufacturers to produce food and drinks that meet consumers demands and societal needs, including for healthier and more sustainable diets.
The Spanish National Research Council (CSIC) submits this contribution in response to the public feedback process opened by the European Commission following the adoption of the Biotech Act on 16 December 2025. As Spains largest public research organisation and a key actor in the European Research Area, CSIC draws on its extensive experience in robotics, artificial intelligence, and applied ethics to focus its…
Stellungnahme zum Biotech Act I A. Grundsätzliches Der VDGH begrüßt die Initiative der Europäischen Kommission, mit dem Biotech Act I die Rahmenbedingungen für Forschung, Entwicklung, Skalierung und regulatorische Begleitung biotechnologischer Gesundheitsinnovationen in Europa zu verbessern.
Filed in German · English published by the European Commission
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
The European Organisation for Research and Treatment of Cancer (EORTC) welcomes the Biotech Act as an initiative to support clinical research by improving the European legal framework. The Acts preamble explicitly outlines a commitment to supporting clinical trial sponsors, and particularly non-commercial sponsors that conduct the majority of minimal- and low-intervention clinical trials in the Union.
BIO Deutschland e.V. welcomes the European Commissions move towards a European Biotech Act to restore the competitiveness of the biotechnology industry, remove existing barriers for businesses and promote Europe as a location for innovation. As the Biotech Act itself rightly describes, biotechnology is one of the sectors that shapes the future.
The European Blood Alliance (EBA), representing public and non-profit blood establishments across Europe, welcomes the European Commissions proposal for a European Biotech Act. EBA wishes to remind EU and national policymakers that public and non-profit blood establishments are the original precursors of personalised medicine and have played an historic and central role in the development of many ground-breaking…
30 mars 2026 Ref. Ares(2026)3346899 - 30/03/2026 Position de la CNCPI sur les aspects propriété intellectuelle de la proposition de « European Biotech Act » 2025/0406(COD) La Compagnie nationale des conseils en propriété industrielle (CNCPI) est l’organisme officiel français regroupant tous les conseils en propriété industrielle, à savoir les professionnels libéraux spécialistes de la propriété industrielle exerçant…
Filed in French · English published by the European Commission
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
EIT Health welcomes the Commissions Biotech Act proposal to boost European competitiveness & innovation, via the biotech sector. The key drivers outlined by the Commission are explored in a recent EIT Health Think Tank report, Skills, scale and science: Uniting European Innovation Ecosystems through the Biotech Act, by industry experts.
Roche welcomes the European Commission's proposal for the Biotech Act. As one of the world's largest biotech companies, we view this Act as a critical opportunity to restore Europe's competitiveness in the global life sciences landscape.
I. Ground conflict: There is a need to protect scientific freedom and strategic protection of knowledge biotechnological knowledge as strategic knowledge. However, strategic governance, security interests and economic exploitation constraints interfere with the day-to-day life of research and can create contradictions with regard to the freedom of research and teaching. ‘II.
Filed in German · English published by the European Commission
Biotechnology is essential for securing a stable and sustainable supply of key pet food ingredients, including amino acids, vitamins, enzymes, probiotics, and bio-based proteins. The European Biotech Act offers a needed opportunity to simplify todays regulatory landscape and strengthen ingredient availability.
· · filed 18 Mar 2026 · source
DI Food welcomes the proposal for a European Biotech Act. Although the primary focus is on the health sector, the regulation is highly relevant for the food and feed area. A central element of the proposal is the introduction of regulatory sandboxes under the General Food Law.
The Sub-directorate for Food Safety welcomes the European Commission’s initiative to establish a regulatory framework to strengthen the European Union’s industrial, innovative and competitive capacity in biotechnology.
Filed in Spanish · English published by the European Commission
Deutsche Krankenhausgesellschaft e.V. (DKG) welcomes the proposal for a European Biotech Act and the adaptation of the European regulatory framework in order to create an environment conducive to innovation and development and thus to speed up or facilitate the market introduction of, for example, ATMPs.
Filed in German · English published by the European Commission
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Revitalised Medicine praises the Commission for making significant improvements in the way innovation is pursued through the Biotech Act, and this regulation proposal addresses many issues in institutional frameworks (e.g. regarding personnel, data sharing, and technological integration).
· · filed 11 Feb 2026 · source
Empowered By Us welcomes the publication of the Proposal for a Regulation establishing the European Biotech Act. The structured framework and focus on strengthening health biotechnology capacity in the Union are important steps toward enhancing competitiveness and resilience. At the stage of Commission adoption, we offer three targeted observations to strengthen implementation effectiveness. 1.
· · filed 7 Feb 2026 · source
Overall assessment The proposed European Biotech Act addresses several well-documented barriers that currently limit the EUs ability to translate strong life-science research into timely patient benefit and sustainable economic value. In particular, its focus on regulatory predictability, clinical trial efficiency, digitalisation, and support for SMEs and spin-offs is welcome.
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, Fondazione Telethon suggests that the scope of this initiative is broadened also to non-profit entities engaged in the…
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 assessment bodies with expertise in in silico medicine, we support the European Commissions efforts to support the needs of…
Bio Base Europe Pilot Plant (BBEPP), based in Ghent, Belgium, is a leading open-access pilot facility that supports the scale-up of biobased innovations from lab to industrial scale. With over 15 years of experience and involvement in more than 450 scale-up projects, BBEPP provides valuable insights into the challenges faced by startups and SMEs in the bioeconomy sector. 1.
Feedback on the Call for Evidence on the Biotech Act GreenLight Biosciences develops and delivers next-generation biocontrol solutions for farmers (and beekeepers). Our biological technology represents a significant advance toward providing European farmers with sustainable alternatives to chemical pesticides.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
With regard to the use of biotechnology in agriculture, POLLINIS called for the utmost caution. These technologies are new, and we have no backsliding on their potential impacts on the environment and human health, but also more generally on their socio-economic impacts.
Filed in French · English published by the European Commission
Plantum, the Dutch association for plant breeders and young-plant producers, welcomes the European Commissions initiative for a comprehensive EU Biotech Act. As a sector that continuously transforms scientific breakthroughs into practical solutions, we strongly support a legislative framework that enables biotechnological innovation across Europe.
The Danish Government strongly supports the European Commissions ambition to promote biotechnology as a key strategic technology for Europes competitiveness, sustainability, resilience and economic security. Biotechnologies hold great transformative potential across multiple domains.
We welcome the European Commissions initiative to modernize the EUs biotechnology framework. To fully unlock the potential of agricultural innovation, the Biotech Act must address regulatory inefficiencies, support advanced plant breeding, stimulate innovation and foster public trustas emphasized by Euroseeds, CropLife Europe, and other industry stakeholders.
SecureDNA Foundation welcomes the European Commission's initiative to establish a European Biotech Act as a critical opportunity to secure Europe's biotechnology leadership while ensuring responsible innovation.
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 position is outlined in the attached paper.
As food biotechnology companies, we strongly support this initiative. In particular, we hope, for example, that the authorisation process will be faster and, ultimately, faster decisions will be made. In particular, for start-ups, in addition to funding, the respective permitting procedures are an enormous challenge.
Filed in German · English published by the European Commission
Contribution from the SPHERE Group The SPHERE Group is a European industrial player in household and professional packaging. Engaged in the transition to a low-carbon and circular economy for several years, SPHERE has been investing heavily in the research, development and industrialisation of bio-based and compostable plastic packaging solutions.
Filed in French · English published by the European Commission
· · filed 11 Jun 2025 · source
Farmindustria, in line with EFPIA, welcomes the Commission’s initiative to establish a Biotech Act, which aims to create an environment conducive to the development and growth not only of the biotech sector but, more generally, of the entire pharmaceutical sector. An ecosystem that can adapt to future scientific and technological advances, promoting the EU’s competitiveness and sustainability.
Filed in Italian · English published by the European Commission
Europe is a powerhouse of science and innovation. Nevertheless, Europe is lagging other innovative regions when it comes to translation science and innovation into development, manufacturing and use of innovative treatments, as confirmed by the Draghi report.
EURORDIS-Rare Diseases Europe welcomes the EU Biotech Act as a pivotal opportunity to establish the EU as a leader in biotechnology, particularly through a focus on rare diseases (RD). With 30 million people affected by RDs across Europe, and only 6% of these conditions having approved treatments, the field represents both a significant public health challenge and a strategic area for biotech innovation.
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, biosecurity, and risk management policy.
Drawing on over 150 years of research and innovation, dsm-firmenich is a pioneer in the use of modern biotechnology to develop, manufacture and commercialize new and better food and beverage ingredients, essential nutrients, fragrances, personal care and health products.
On behalf of the Biosimilar medicines group, a Medicines for Europe sector group, please find attached our contribution on the future Biotech Act. The Biosimilar Medicines Group represents the leading companies developing, manufacturing and/or marketing biosimilar medicines across Europe. Our members contribute actively to the European biotech ecosystem, including through innovation on processes.
· · filed 11 Jun 2025 · source
The Austrian Social Insurance welcomes the European Commissions initiative aimed at strengthening the competitiveness of the biotechnology sector in the Union as well as the overall strategic autonomy. In this context, the following should however be closely taken into account: We fully support enhance the Made in Europe principle to boost the attractiveness of Europe through targeted incentives to attract and…
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Boehringer Ingelheim is a leading research-driven biopharmaceutical company committed to advancing human and animal health. As one of the industrys top global investors in R&D, we focus on developing innovative therapies that address areas of high unmet medical need, improving and extending lives worldwide.
PHARMIG, the voluntary representation of the Austrian pharmaceutical industry, strongly supports the objective of the announced European Biotech Act: Creating a world-class innovation environment for biotechnologies! Among other things, PHARMIG is working to maximise the potential of the competitive pharmaceutical sector.
Filed in German · English published by the European Commission
Biotechnology has made enormous advances over the last years. It provides an entirely new approach, offering opportunities that were, a few decades ago, almost unimaginable. Biotechnologya sector that has flourished in other parts of the world and is largely lagging in Europe holds immense potential to tackle some of the EUs most pressing challenges.
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 robust IP framework.
FAMHPs contribution to the call for evidence for an impact assessment in view of a Biotech Act The FAHMP welcomes the initiative for a future Biotech Act. Biotechnology is a cornerstone of innovation and resilience for the European Unions health sector.
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 are disproportionately impacted by a number of issues.
Ecolab welcomes the opportunity to contribute to the development of the EU Biotech Act - an essential initiative to strengthen Europes life sciences framework and its role in biotechnology and biomanufacturing. As a global sustainability leader, Ecolab - through its Life Sciences business - supports pharmaceutical and biopharmaceutical manufacturers with advanced purification resins, contamination control…
You can read the English version below. Geachte Europese Commissie, De regio Utrecht, door de Europese Commissie bestempeld als “meest competitieve regio van Europa” en door de Europese Commissie aangewezen als Regional Innovation Valley op het gebied van gezondheidsinnovatie, beschikt over een unieke combinatie van hoogwaardige kennisinstellingen, (academische) ziekenhuizen en onderzoekscentra, zoals het…
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
The European Commissions initiative to develop a European Biotech Act can strengthen its biotech sector. The legislation should achieve this goal by ensuring regulatory coherence, enabling biotech innovation, strengthening supply chain resilience, supporting new technologies and deepening transatlantic cooperation.
CSL is a global biotechnology leader with a dynamic portfolio of lifesaving medicines, operating in highly specialized areas that require advanced, complex technologies, broad scientific expertise, and sustained long-term investment.
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MEDAC is a German-based pharmaceutical company with production sites in Germany and Czechia, which, in addition to medicines with conventional chemical manufacturing processes, also develops, manufactures and distributes biotechnological drugs for cancer and autoimmune diseases.
Filed in German · English published by the European Commission
· · filed 11 Jun 2025 · source
BioSpring welcomes the European Commissions initiative to introduce a dedicated EU Biotech Act. As a world-leading manufacturer of therapeutic active ingredients based on synthetic nucleic acids, we support efforts to strengthen Europes biotechnology ecosystem.
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Cancer Patients Europe (CPE) welcomes the opportunity to contribute to the European Commissions call for evidence on the proposed Biotech Act. We fully support its aim to establish a robust, forward-looking policy framework to strengthen Europes leadership in biotechnology, particularly in healthcare.
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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.
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 probioticsoffer transformative potential for advancing the EUs green transition and economic competitiveness.
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 biotechnology, sustainable (aqua)feed, and circular economy, we offer the following input: a) Infrastructure for Innovation The…
Pharma Deutschland welcomes the European Commissions intention to present a comprehensive Biotech Act in 2026. The sector is indeed fast-moving, research-intensive, and capital-demanding. A modern legislative framework is therefore urgently needed to improve translational capacity, reduce regulatory fragmentation, and facilitate market and global access for biotech products.
Response from the European Respiratory Society (ERS) and the European Lung Foundation (ELF) to the European Commission Call for Evidence on the European Biotech Act The European Respiratory Society (ERS) and the European Lung Foundation (ELF) appreciate the European Commissions initiative and efforts to create a forward-looking European Biotech Act, recognising the important role biotechnology plays in improving…
The potential outcomes and benefits of the use of biotechnology are numerous, infinitely beneficial, and therefore its recognition as a key enabler of the EUs goals and aspirations is a natural progression. We therefore welcome the European Commissions renewed intention to capitalise on this technology to meet its strategic goals of transitioning to a greener planet and economy, providing safer, affordable…
· · filed 11 Jun 2025 · source
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 biologically-based technologies such as AI, organ-on-a -chip, 3D tissue models and transcriptomics.
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 sustainability footprint of many industries, without compromising on performance.
1. Expand the scope of the Biotech Act - In March 2024, the European Commission sent a strong signal to the bio-based industries with the publication of the Communication on Boosting Biotechnology and Biomanufacturing in the EU. - The EU biotech Act should build on that vision to accelerate the pathway to technology, including biotechnology, and biomanufacturing at scale.
EBIC is the European Biostimulants Industry Council, the trade association for plant biostimulants in Europe. Founded in 2011, our vision is sustainable agriculture supported by the global adoption of plant biostimulants. We are dedicated to fostering the growth, development and fair regulation of our industry.
Creation of the EU Biotech Act comes at a pivotal moment in world events, and represents a rare opportunity for the EU to secure a leading role. New Harvest Netherlands appreciates the opportunity to contribute to its development. Our recommendations can be found in the submitted document.
The European Social Insurance Platform (ESIP), representing national social security and health insurance institutions across Europe, views positively the European Commissions initiatives to boost the EU life sciences sector, particularly the upcoming European Biotech Act.
The European Brain Council (EBC) welcomes the announcement of the upcoming European Biotech Act as an essential component of the broader EU Life Sciences Strategy. Despite recent breakthroughs in our understanding of the human brain, brain conditions are still amongst the most complex conditions to understand and treat.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
Synpa-des alimentaires de speciality represents producers and distributors of specialty food ingredients in France. These ingredients are essential for the production of food: Traditional foods: beers, wines, cider and perry, PDO cheeses, sausages, cooked hams Breakfast Cereales, dairy products (cheese, yoghurt, curd, fermented milk, fresh cream, lactose reduced milk), ice cream, bakery products, charcuterie…
Filed in French · English published by the European Commission
The Coalition for Epidemic Preparedness Innovations (CEPI) welcomes the European Commissions initiative to present an EU Biotech Act. As a global partnership dedicated to accelerating the development of vaccines and biologic countermeasures against epidemic and pandemic threats, CEPI has seen firsthand the importance of a strong, innovation-driven biotechnology sector for Europes health security and economic…
Call for Evidence, EU Biotech Act MICROBS fully support the objectives of the EU biotech Act, which seeks to strengthen the global competitiveness of the EU biotechnology sector while maintaining high safety standards in health innovation.
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Biotech chemicals regulation Biotechnology is a major asset for decarbonising the chemical industry, while strengthening its competitiveness and anchoring its value chain on the European continent. They allow the production of diverse molecules, whether platform molecules that can replace petrochemical bricks, or more complex compounds used in various applications (coatings, adhesives, dyes, hygiene products, etc.).
Filed in French · English published by the European Commission
· · filed 11 Jun 2025 · source
The French authorities share the Commission’s findings on the issues linked to the deployment of biotechnology, in particular for the production of biocontrol plant protection products and novel foods. Biocontrol plant protection products do not have, at this stage, a legislative and regulatory framework which distinguishes them from other plant protection products and which makes it possible to speed up their…
Filed in French · English published by the European Commission
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, as both biotechnology and biomanufacturing offer significant opportunities.
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The triangle collaboration between Aarhus University, Wageningen University and Research, and the French National Research Institute for Agriculture, Food and Environment (INRAE) strongly welcomes the European Commissions ambition to deliver a regulatory framework for biotechnology that can fully embrace the entire scope of biotechnology and enable the very significant opportunities embedded within this domain.
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 future pharmaceutical legislation and implementing acts of the Regulation on Substances of Human Origins (SoHO).
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BIOTECH ACT: The French authorities share the findings of the March 2024 communication and the Draghi report on European competitiveness. The biotechnology sector is growing strongly and plays a key role in the competitiveness of the EU, but this dynamic faces several challenges: global competition, regulatory fragmentation and reduced investment.
Filed in French · English published by the European Commission
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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 average in R&D+i.
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, ongoing and future regulation must ensure innovation and competitiveness without imposing additional regulatory burdens.
Biotechnologies are crucial for the EU chemical industry, driving economic growth, innovation, and sustainability. Cefic shares the overall objective of the Biotech Act to improve the size and competitiveness of the biotechnology and biomanufacturing sector in the EU while maintaining high safety standards and to ensure that the EU makes the most of the biotech revolution for the benefit of society, the environment…
11 June 2025 The EU Biotech Act – an opportunity to drive the uptake of biocontrol IBMA, the association representing biological control manufacturers in Europe and globally, welcomes the European Commission’s plans for a European Biotech Act.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
Humane World for Animals welcomes the European Commissions initiative to develop a European Biotech Act as part of the broader Strategy for European Life Sciences. Among the identified challenges, the Act highlights the medical and pharmaceutical sector, as a key area requiring greater efforts to enhance EU competitiveness and sustainability.
· · filed 11 Jun 2025 · source
The International Biosecurity and Biosafety Initiative for Science (IBBIS) welcomes the European Commissions plan to introduce a European Biotech Act. A robust biotechnology sector is central to Europes economic resilience, global competitiveness, and health security. However, achieving this vision requires addressing persistent fragmentation in policy and regulation, particularly in biosecurity governance.
AstraZeneca welcomes the European Commissions efforts to strengthen the competitiveness of the European biopharmaceutical industry through the Biotech Act. It is an important opportunity to enhance sector competitiveness and to unlock the transformational impact of biopharmaceutical innovation on peoples lives.
RESPONSE TO THE EUROPEAN COMMISSION’S CALL FOR EVIDENCE FOR AN IMPACT ASSESSMENT FOR THE EUROPEAN BIOTECH ACT Submitted by the Johns Hopkins Center for Health Security Thank you for the opportunity to provide feedback on this initiative for a European Biotech Act.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
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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 to strengthen and streamline the coordination of metrology research, innovation, and service provision across Europe.
Vaccines Europe (VE) strongly supports the EFPIA submission. Additionally in this response, VE would like to emphasize the specific needs for vaccine innovation in Europe. Innovation in prophylactic vaccines has never been more critical.
The German Association for Synthetic Biology (GASB e.V.) welcomes an EU Biotech Act, which we regard as a key element in leveraging the European biotech sector for a transition towards a circular bioeconomy, thereby facilitating numerous benefits for the economy, society, and the environment. Please find our feedback attached.
The Biotech sector is facing several challenges that threaten and limit its competitiveness in the EU, among them: regulatory barriers, R&D investment gap, global competition, supply chain vulnerabilities. EU needs to operate decisive actions to tackle those challenges and enable its biotech industry and the ones behind them, to grow and create value.
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 Evidence. To ensure its success EBC agrees the Biotech Act should be bold and broad and include all relevant sectors i.e.
DI response to the Call for Evidence on a European Biotech Act DI appreciates 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 Evidence.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
The European Association of Hospital Pharmacists (EAHP) welcomes the opportunity to provide input to the preparation of the Biotech Act. EAHP represents over 29,000 hospital pharmacists across 36 member countries. EAHP represents and develops the hospital pharmacy profession within Europe in order to ensure the continuous improvement of care and outcomes for patients in the hospital setting.
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Novo Nordisk A/S welcomes the European Commission's (EC) initiative to develop a Biotechnology and Biomanufacturing Act, aiming to transform Europe from being a regulatory leader to a global champion of biotechnology innovation.
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 biotechnology industry sector.
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 main drivers that limit the full potential of the biotech research and innovation in Europe.
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 sustainability and competitiveness in the March 2024 Commission Communication on biotechnology and biomanufacturing.
Biotechnologies play a vital role in achieving EU climate goals, addressing societal and environmental challenges, and enhancing economic competitiveness. In March 2024, the European Commission sent a strong signal to the biotech and biomass derived industries with the publication of the Communication on Boosting Biotechnology and Biomanufacturing in the EU.
Sanofis response to the European Commissions Call for Evidence on EU Biotech Act Sanofi welcomes the European Commission's initiative to develop a European Biotech Act. We believe this represents a critical opportunity to strengthen Europe's position in the global biotech landscape while addressing key challenges facing the sector.
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Position paper from WEWIS/EWI A) Crucial elements of the EU Biotech Act I. Secured access to and storage of health/ sensitive data in Europe: a) Establish a European cloud storage facility for sensitive data, including health and genome data; b) Establish a European Secured Processing Environment for the analyses of sensitive data.
Roche welcomes the objective of the European Commission's Biotech Act initiative. Europe can regain competitiveness by transforming into an efficient ecosystem that leverages the single market with unified rules, fostering Research & Development for innovative medicines and integrated solutions.
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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 health area. We applaud the European Commission on the initiative to strengthen biotech in Europe.
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EU Biotech Act - Accelerate Regulatory Convergence for Research with Biological Samples Clinical trials are a prerequisite for health innovation and technology adoption. The EU is competing globally to remain an attractive region for clinical trials. European regulatory bottlenecks for clinical trials are unacceptable. Identification and elimination of these bottlenecks should be a high priority.
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. 1.
The Danish Chamber of Commerce strongly support the European Commissions ambition to revitalise the EUs biotechnology and life sciences ecosystem through a comprehensive and forward-looking Biotech Act. An ambitious and innovative policy approach is essential to leverage the full potential of biotechnology in addressing societal, environmental, and economic challenges, while reinforcing Europes strategic autonomy.
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The European Biotech Act represents a vital opportunity to reassert Europes leadership in biotechnology. Its success depends on achieving concrete structural improvements in the EU's regulatory and investment environment, while recognizing and taking into account the transformative shift in biotechnology from a series of specialized, sector-specific applications to a fundamental, cross-sectoral, general-purpose…
As a research-intensive global healthcare leader, MSD is committed to developing innovative medicines and vaccines that save lives and improve the health and well-being of people worldwide. With a significant footprint in the EU, we welcome the opportunity to emphasise the critical importance of the upcoming Biotech Act in shaping a competitive and future-proof biopharmaceutical ecosystem for Europe.
The Novo Nordisk Foundation and its investment company Novo Holdings welcome the opportunity to respond to the European Commission's Call for Evidence on the European Biotech Act. Advancing biotech capabilities is essential for positioning the EU at the forefront of technology, fostering growth in sectors crucial for sustainable socioeconomic development and security.
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Medical biotechnology plays a crucial role in discovering and developing innovative therapies that can significantly improve patient outcomes and enhance the competitiveness of the European pharmaceutical sector.
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, ongoing and future regulation must ensure innovation and competitiveness without imposing additional regulatory burdens.
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Europe needs competitiveness. Elevating European bioeconomy as a driver of competitiveness requires broad understanding. While biotechnology is an important part of the bioeconomy, it is too narrow when considering industrial production and global business opportunities. Thus, the Finnish Forest Industries Federation emphasizes that the Biotech Act must adopt a comprehensive approach.
The organic movement welcomes the opportunity to give input to the Biotech Act. The maintenance of a system of identification and traceability for genetically modified products in agriculture is essential so that organic and conventional operators have the right and freedom to continue producing GM-free throughout the entire supply chain. Please find the full feedback attached.
The upcoming Biotech Act offers an opportunity to enhance Europes position as a global leader in biotechnology. To remain at the forefront of scientific breakthroughs, the EU must adopt policies that address the challenges and leverage the opportunities in the biotech space.
Biotechnology plays a key role in driving the transformation towards sustainable industrial production. It offers innovative and improved solutions across various sectors, including healthcare, food production, chemical manufacturing, and industrial processes. Biotechnology enables advancements such as more personalized healthcare, sustainable agriculture, and environmentally friendly products.
Rigshospitalet, Copenhagen University Hospital, welcomes the European Commissions initia-tive to develop a comprehensive EU Biotech Act and appreciates the opportunity to contribute to its consultation process. As an entity Rigshospitalet is a highly specialised hospital for all of Denmark, with treatment, research, innovation and training at international level.
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We welcome the objectives of the European Biotech Act and its potential to create an enabling framework for innovation across the biotechnology sector. We would like to highlight the importance of ensuring that nano-enabled solutions in biotechnology, particularly in medical and pharmaceutical applications, are appropriately addressed within this framework.
AnimalhealthEurope Feedback to the Commission Consultation on A European Biotech Act June 2025 AnimalhealthEurope, the association representing the manufacturers of veterinary medicines, vaccines and other animal health products highly appreciates and welcomes the Commission intention to propose a new “European Biotech Act”.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
Prague, 10 June 2025 BMT Response to the Call for Evidence on the European Biotech Act Bene Meat Technologies a.s. welcomes the European Commission's ambition to establish a regulatory framework that fully encompasses the breadth of biotechnology and unlocks its substantial potential.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
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The Canary Islands, as the outermost region (ORs) of the European Union, would like to highlight the urgent need to integrate the specific challenges and opportunities of the outermost regions into the future European Biotechnology Law. There is a territorial imbalance in the European biotechnology ecosystem, strongly concentrated in continental regions, which limits the development of decentralised poles.
Filed in Spanish · English published by the European Commission
Eurogroup for Animals welcomes the European Commissions Biotech Act as a chance to unlock circular, sustainable, and competitive food systems as well as to embed ethical, impactful innovation in EU biotechnology.
The German BfN wants to highlight the importance of an Environmental Risk Assessment (ERA) process targeting environmental effects, along with the implementation of appropriate safeguards within the biotechnology sector including genetic engineering.
Biotechnology plays a significant role in the development of medical devices and in vitro diagnostics (IVDs). For medical devices, this includes implantable devices and bioprinting. For IVDs, biotechnologies are crucial for genetic testing, encompassing molecular diagnostics for both infectious and non-infectious diseases, as well as Next Genome Sequencing.
Consultation on the planned legislative initiative EU Biotech Act (initiative No 14627) Dear Madam and AG Pro Biosimilars is representing the interests of biosimilar companies in Germany. It is open to all companies that develop, produce and supply biosimilars. The working group under the umbrella of Pro Genetic Medicines e.V.
Filed in German · English published by the European Commission
The Spanish Hospitalary Pharmacy Society (SEFH), aware of the great importance for all citizens of the European Union of the future Law on Biotechnology due to its economic, scientific and health impact, thanks to the possibility of participating in its impact assessment, in order to improve or adapt some of its aspects and is confident that its contributions will be taken into account.
Filed in Spanish · English published by the European Commission
Novonesis strongly supports the Commissions intention to develop an EU Biotech Act that aims to address the challenges and barriers faced by biotechnology across several sectors (including agriculture, food and feed, environment, and industry). The upcoming Biotech Act is Europes best chance to chart a new course for the biosolutions sector.
EFFCA welcomes the Commissions initiative to establish a European Biotech Act to support the EU biotechnology sectors competitiveness, resilience, and sustainability. We fully support the goal of enhancing the translation of innovation into market-ready solutions, particularly in the food sector, where fermentation and microbial technologies are critical. The Biotech Act presents an opportunity to create a…
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 commercial route, with extremely high prices.
The Life Science Manufacturers Association (LSMA) champions Europe's biotechnology and biomanufacturing sectors, advocating for policies that foster innovation and global access to critical technologies. LSMA and its members are key to healthcare, pandemic preparedness, and Europe's industrial strategy, striving to accelerate innovation, navigate regulatory complexities with proportionate, science-based approaches…
The Helmholtz Association of German Research Centres supports the European Commission's efforts to strengthen biotech innovation in Europe. The attached document outlines our key recommendations for enhancing the biotech sector by addressing various stages of the innovation continuum, from basic research to commercialization.
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 disproportionately affects SMEs.
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 strengthening the EUs competitiveness, resilience, and strategic autonomy.
We welcome the Biotech Act, to speed up the development of biotechnology and biomanufacturing, being the former a key tool to enhance the use of renewable raw materials and scraps, boosting the bioeconomy in different sectors as agriculture, energy and chemical industry.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) supports the European Commissions initiative to develop a Biotech Act and its overarching objective to reinforce the biopharmaceutical research and innovation ecosystem, allowing companies to thrive in the EU.
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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.
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Paediatric Loncology is an area whose potential is still largely under-exploited. A genuine single market for biotechnology in the European Union would be the ideal framework for the research, treatment and ultimately cure of laughter cancer.
Filed in French · English published by the European Commission
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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.
Brussels, 11 June 2025 Cepi Contribution to the European Biotech Act – Unlocking Bioeconomy Potential The European Biotech Act, as currently outlined in the Commission’s Call for Evidence, focuses primarily on medical, pharmaceutical, and select agricultural or industrial biotechnology applications.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
bioMérieux fully supports the objectives of the EU biotech Act, which seeks to strengthen the global competitiveness of the EU biotechnology sector while maintaining high safety standards in health innovation. As a global manufacturer and supplier of pharmaceutical quality control solutions, bioMérieux firmly believes that this objective will only be achieved if quality control is fully integrated into the whole…
Compagnie nationale des agents en propriété industrielle (CNCPI) is the French official body comprising all industrial property agents, namely the liberal professionals specialising in industrial property operating in France. In the context of the public consultation on the European Biotech Act, the CNCPI wishes to bring the attached position paper to the attention of the European Commission.
Filed in French · English published by the European Commission
The twelve Dutch provinces and the state of BadenWürttemberg present their position paper on biotechnology The European Commission has announced an initiative on biotechnology and bio-production in its work programme for 2024. The state of BadenWürttemberg and the province of Noord-Holland, on behalf of the House of Dutch Provinces, welcome the initiative.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
EFPIA strongly support the ambition to foster a world-class innovation environment for biotechnologies.To make the EU more attractive for researching, developing and manufacturing new technologies,we urge coordinated and urgent action across several areas.
The European Patients Forum (EPF) welcomes the opportunity to respond to the European Commissions Call for Evidence on the forthcoming EU Biotech Act. As an umbrella organisation representing patient organisations across Europe and across disease areas, EPF is calling for the EU Biotech Act to ensure a patient-centred health innovation agenda that places patients at the heart of this initiative.
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 development in Europe.
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**** General Feedback**** We strongly support the integration of data and artificial intelligence (AI) as a central axis of the EU Biotech Act. AI is a critical enabler of productivity, innovation, and global competitiveness in the European biotech sector. Among all industrial domains, biotechnology is arguably the one where AI holds the highest potential to generate economic, societal, and environmental value.
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 the EU will be out-innovated by other countries and regions in the future.
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 resilient and responsible biotechnology ecosystem.
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 barriers across the innovation pipeline, 1.
VTT fully supports the development of an European Biotech act harvesting the full potential of the Biotechnologies in bringing products and services to the market and enhancing European industry competitiveness.
1 (6) Regionledningskontoret 2025-06-11 Inspel - Call for Evidence Biotech Act Initiativet, Biotech Act, har som övergripande mål att öka storleken och konkurrenskraften hos biotekniksektorn i EU, samtidigt som man upprätthåller en hög säkerhetsnivå. Den nya europeiska biotekniklagen ska se till att EU kan dra nytta av bioteknikrevolutionen på bästa sätt, för att skapa fördelar för samhället, miljön och ekonomin.
Filed in Swedish · English published by the European Commission
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
The Rare Disease Moonshot welcomes the European Commissions ambition to develop a comprehensive EU Biotech Act. This initiative represents a timely opportunity to unlock the full potential of biotechnology as a strategic driver of health innovation, economic resilience, and scientific leadership in Europe.
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Thank you for the opportunity to provide feedback on the upcoming EU Biotech Act. We welcome the Commissions commitment to creating an enabling environment for the biotech sector, while upholding the highest standards of safety for the population and the environment. We would like to highlight the following points for consideration: 1.
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Contribution to the EU Public Consultation on the Biotech Act Submitted by the Executive Committee (ComEx) of DIM BioconvS, Île-de-France Region (Paris Region) We welcome the European Commissions initiative to develop a European Biotech Act aimed at accelerating innovation, industrial resilience, and strategic autonomy.
Euroseeds, the voice of the European seed sector, welcomes the European Commissions initiative to modernize the regulatory framework for biotechnology and biomanufacturing. Representing a broad membership across all EU Member States and internationally, Euroseeds emphasizes the urgent need for a science-based, innovation-friendly, and proportionate regulatory environment to support plant breeding innovation. 1.
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 in both biotechnology and biosecurity.
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 happy to provide any more details needed upon request.
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, Karen Noonan Senior Vice President, Global Regulatory Policy ACRO
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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 life with type 1 diabetes better while drivingtoward cures.We do this by investing in the most promising research…
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Perstorp supports the aim to create a modern regulatory environment for biotechnology in the EU, by application of science to produce knowledge, goods and services. Manufacture of products using biological processes, such as fermentation, cell culture, and genetic engineering are of outmost importance for the well fare of the society, the environment, and the leadership of the EU.
We welcome the European Commissions (EC) initiative to develop an ambitious and comprehensive Biotech Act that positions Europe as a global leader in biotechnology. We ask the EC to take a focused and tailored approach to healthcare biotechnology within the broader EU biotech strategy.
Contribution Ajinomoto Foods Europe au futur Biotech Act Profil de l’entreprise : Notre entreprise est un acteur de référence dans la bioproduction d’ingrédients alimentaires par fermentation, ainsi qu’un CDMO (Contract Development and Manufacturing Organization) spécialisé dans les procédés dédiés aux biotechnologies industrielles.
Filed in French · English published by the European Commission
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
A4BEE welcomes EUs efforts to promote biotechnology in order to strengthen the sectors competitiveness and ensure therapeutic and economic safety. In the current era of geopolitical realignment and technological acceleration, the EU stands at a critical juncture to redefine its role in the global biotechnology sector.
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.
The EU Biotech Act should outline how to ensure coherence and interplay across different (non)legislative frameworks impacting companies to avoid duplication or inconsistencies. The cumulative impact of overlapping or complex requirements in CT, health data and environmental management can hinder innovation.
Brussels, 10 June 2025 EPF Response to the Call for Evidence on the European Biotech Act The European Panel Federation (EPF) welcomes the initiative for a European Biotech Act. We appreciate the Commission’s commitment to unlocking the full potential of biotechnology and biomanufacturing to drive sustainability, competitiveness, and resilience across EU industries.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
The CNRS welcomes the Commissions initiative to develop a coherent and ambitious European Biotech Act. Our contribution underscores the critical role of fundamental research in shaping the biotech of the future, the importance of interdisciplinary ecosystems for innovation, and the need for EU-wide coordination to overcome fragmentation and accelerate deployment.
The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organisation representing the advanced therapy medicinal products sector, which includes cell and gene therapies and tissue-engineered products. ARMs membership includes more than 400 organisations, ranging from small and medium-sized enterprises and large companies to academic institutions and non-profit research centres.
HIPRA welcomes the European Commission's efforts to develop a proposal for an EU Biotech Act. We believe that Europe is at a crucial juncture and, as highlighted in the Draghi report, the pharmaceutical industry plays a vital strategic role in the European economy.
Europe has long invested in biotech excellence. But while global competitors are scaling innovation, Europe too often stalls due to fragmented regulation and insufficient commercialization support. The risk is real: we lose talent, miss out on global leadership, and fail to capture the full value of EU-grown biotech breakthroughs. The EU Biotech Act must change that.
AseBio, the Spanish Bioindustry Association, represents the Spanish biotechnology sector, brings together a diverse ecosystem of over 300 entities, including innovative small and medium-sized enterprises (SMEs), large corporations, and other key players.
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, harmonized education, and advocates for equitable access to innovative therapies for patients with hematological diseases…
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The Netherlands National Institute for Public Health and the Environment (RIVM) houses the GMO office and in that role permits GMO activities and advises the Competent Authority on the GMO dossier. RIVM welcomes the initiative to strengthen the European biotechnology sector. An important sector that adds to the improvement of public health and the sustainability goals.
1) Challenge - Capital Market Reform: European biotech IPOs underperform due to a fragmented and underdeveloped public market infrastructure. Low liquidity, lack of specialist analyst coverage, and poor regulatory fit discourage long-term investment and scale.
1) Challenge - Addressing the funding gap European biotech companies face a severe shortage of growth-stage financing, particularly in Phase II and III clinical development. The investment ecosystem is heavily weighted toward early-stage assets, lacking the scale and continuity to support companies as they mature.
Biotechnologies play an essential role for the delivery of EU objectives for competitive, healthy, resilient and sustainable economies and societies. Future-proofing fundamental frameworks across all biotech applications including healthcare, agri-food supply chains, manufacturing processes, chemicals and consumer goods, is critical.
ANOVE, an association representing Spanish breeders of new plant varieties, welcomes the Commission’s initiative to modernise the regulatory framework for biotechnology. There is an urgent need for businesses to have adequate regulation of biotechnology applied to agriculture and food that is conducive to innovation in the area of plant genetic breeding and the breeding of new plant varieties.
Filed in Spanish · English published by the European Commission
Competitiveness is a strong claim. It is needed for every regulation and action. We are talking about very competitive competition - internationally. It is therefore essential for the EU Biotech Act to think big in order to create the framework conditions for biotech start-ups, growth companies and established companies to be the best internationally.
As an organization actively involved in supporting life sciences companies across Europe, we welcome the European Commissions efforts to develop the EU Biotech Act. This initiative comes at a crucial time, as the biotechnology sector faces increasing global competition and regulatory complexity that often hinders innovation.
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Biotechnology is essential to the EUs healthcare innovation, enabling advanced treatments and better outcomes for citizens. The BPI sees the EU Biotech Act as a key opportunity to accelerate this progress. For the EU to regain leadership in breakthrough therapies, it must rapidly translate scientific advances into accessible treatments through aligned legislative and non-legislative measures, such as the EU…
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 phases of the Biotech Act development.
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.
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.
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The German Social Insurance (DSV) welcomes the European Unions efforts to promote biotechnology in order to improve medical care and ensure supply reliability. In doing so, key principles such as availability, accessibility and affordability as well as a patient-orientated understanding of innovation must take precedence over industrial policy goals.Biotechnological medicinal products are usually highly complex…
The European Society for Medical Oncology (ESMO) welcomes the ambition of the European Commission to launch a proposal for a European Biotech Act. Please find the input from ESMO to the Call for Evidence attached. For further information, please contact: [email removed]
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The Dutch National Growth Fund program, Biotech Booster, warmly welcomes the European Commissions ambition to establish a comprehensive regulatory framework for biotechnology; one that embraces the full breadth of the field and unlocks the vast opportunities it holds for society.
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Lesaffre is a key global player in fermentation for more than a century. Lesaffre, with a 3 billion turnover, and established on all continents, counts 11,000 employees and 100 nationalities. On the strength of this experience and diversity, we work with customers, partners, and researchers to find ever more relevant answers to the needs of food, health, naturalness and respect for our environment.
FoodDrinkEurope welcomes the European Commissions initiative to develop a new Biotech Act and appreciates the opportunity to provide input to this call for evidence. We strongly support efforts to accelerate the transition from research to market for biotechnological innovations, particularly within the food and drink manufacturing sector, which plays a vital role in building more sustainable and resilient food…
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 528/2012) and forest-based industries.
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As the technological centre of the food area in CNTA (National Centre for Food Technology and Safety), we consider it of paramount importance that there is an EU regulation that speeds up the processes for placing novel foods generated by biotechnology on the market.
Filed in Spanish · English published by the European Commission
As National regulator of the GMO in Spain, we sent a detail answer of the survey you conveyed us. Please, check the attached document (250410 respuesta MAPA EUSurvey_Survey.pdf). The document follows the format supplied in your web. If any aclaration is needed, do not hesitate to contact me.
Biotechnology is one of the most promising fields of science today, encompassing countless areas of interest for governments worldwide. It offers potentially revolutionary solutions to problems in environmental science, medicine, agriculture, and energy sustainability. Most notably, biotechnology holds immense potential in accelerating vaccine development across Europe.
SPRING Position Paper on the Biotech Act SPRING – the Italian Circular Bioeconomy Cluster – welcomes the proposed Biotech Act as a key opportunity to accelerate the development of biotechnology and biomanufacturing.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
Drawing from the operational realities of Maltese biotechnology businesses, this submission highlights structural barriers that hinder innovation, competitiveness, and growth. These challenges are directly relevant to the objectives of the upcoming Biotech Act, which aims to simplify procedures, reduce time to market, and strengthen Europes global biotech leadership. Please refer to the attached feedback document.
CALL FOR EVIDENCE FOR AN IMPACT ASSESSMENT TITLE OF THE INITIATIVE: European Biotech Act ČR dlouhodobě podporuje využívání moderních biotechnologií pro výzkumné, průmyslové i zemědělské účely za předpokladu zajištění vysoké úrovně ochrany zdraví lidí a životního prostředí. Biotechnologie vnímáme jako klíčový nástroj pro rozvoj udržitelného zemědělství, inovace ve zdravotnictví a ochrany klimatu.
Filed in Czech · English published by the European Commission
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
As a stakeholder of the global health community working closely with researchers and product developers, DSW draws attention to 5 key points in the development of the European Biotech Act. As outlined in the Commissions 2024 Communication; biotechnology and its applications hold great promise in tackling societal challenges and driving EU competitiveness, including in the areas of health, which is the focus of this…
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I, as EU citizen and pediatric oncologist, share SIOPE feed-back: we welcome the opportunity to contribute to the EU Biotech Act consultation: Cancer remains the leading cause of disease-related death in children and adolescents in Europe, yet innovation continues to bypass the specific needs of this population.
FEFAC representing the European manufacturers of premixtures and compound feed for food producing animals would like to welcome the EU Commission initiative to publish a biotech act and would like herewith to share its perspectives.
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INRAE welcomes the European Commissions ambition to deliver a regulatory framework that can fully embrace the entire scope of biotechnology and enable the very significant opportunities embedded within it. We share below (and in the attached paper) our views and recommendations. 1.
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 area. It is a foundational layer that cuts across all aspects of human life and societal functioning.
To preserve European industrial sovereignty and accelerate the decarbonisation of the economy, the EU needs an enlarged Biotech Act that integrates industrial biotechnology. This regulatory framework should support the scaling up of large-scale industrial infrastructure and support the creation of innovative, sustainable and resilient supply chains adapted to the specificities of these key technologies for the…
Filed in French · English published by the European Commission
Fruit, vegetables, flowers, and plants grown with net-zero emissions nor residues on products. This is our ambition for 2030. Our growers are moving from conventional synthetic to greener plant protection like natural enemies, Biocontrol, precision techniques, and low-risk substances. The past 15 years, the footprint of controlled environment agriculture (CEA) has accordingly dropped by 90 per cent.
Filed in Dutch · English published by the European Commission
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.
A.I.S.E., representing the cleaning and maintenance products industry, welcomes the European Commissions opportunity to contribute to the Call for Evidence on the European Biotech Act. Biotechnology plays a vital role in our sector, particularly through white biotechnology and microbial applications, that enhance product performance. A.I.S.E.
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, sustainability, and innovation.
· · filed 6 Jun 2025 · source
SIOPE (the European Society for Paediatric Oncology) welcomes the opportunity to contribute to the EU Biotech Act consultation on behalf of the childhood cancer community. Cancer remains the leading cause of disease-related death in children and adolescents in Europe, yet innovation continues to bypass the specific needs of this population.
A European Biotech Act: Unleashing innovations in the agri-food sector 6-June-2025 Cellular Agriculture Europe’s members welcome the Commission’s plans for a European Biotech Act and the opening of the call for evidence to develop the initiative.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
· · filed 6 Jun 2025 · source
mock.legal, a law firm specializing in the life sciences sectorincluding MedTech, Pharma, and Biotechsubmits the following feedback regarding the proposed Biotech Act. The recommendations advocate for a streamlined regulation that supports long-term planning and innovation while maintaining regulatory balance.
Amgen, one of the world's leading biotechnology companies, welcomes the opportunity to share our views on the upcoming EU Biotech Act and how this can ensure Europe stays competitive globally. As a company founded in the 1980s that rapidly grew to a multinational pharmaceutical company with operations in more than 100 countries, we believe we can bring valuable experience to the table.
· · filed 6 Jun 2025 · source
At Invest Europe the association representing Europes private equity, venture capital (PE/VC) and infrastructure sectors, including fund managers and investors in biotech and life sciences our members are committed to unlocking the potential of competitive sectors, including biotech. Yet, persistent structural barriers are limiting progress and competitiveness.
Biotechnology and biomanufacturing are central to the EUs green transition, economic resilience, and strategic autonomy. For example open strategic autonomy challenges us to optimize the use of our bio-based raw materials throughout the value chain. Natural Resources Institute Finlands (Luke) recommendations are linked to the recommendations done for the EU Bioeconomy strategy update. 1.
Drawing on its leading expertise in biotechnology, Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB puts forward several priorities to ensure that the Biotech Act can fully support Europes competitiveness, resilience, and sustainability. A key objective must be to bridge the persistent gap between research and industrial application by improving access to finance.
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. It must also foster innovation that is accessible, societally meaningful, and system-ready.
GFI Europe welcomes the opportunity to provide feedback to the call for evidence on the EU Biotech Act. Europe has a real opportunity to lead in food biotechnology. With world-class academic institutions, a vibrant startup ecosystem, and several global leaders in fermentation, the region is well-positioned to drive innovation in this space.
The proposal for a new European Biotech Act is perfectly placed to not only accelerate biotech products from laboratory-to-factory-to-market, but to also expedite the development of non-animal science, including test methods, for the protection of human health and the environment.
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 its potential, the Biotech Act must explicitly include food biotech within its scope.
Biohm is a multi-award-winning nature-led platform company developing world-leading industrial biotechnologies destined for global commercialisation. We seamlessly integrate radical biotechnologies into the worlds most prolific industrial sectors to rapidly decarbonise and regenerate economies.
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 systems will be dependent on its ability to increase its food autonomy, while producing sufficient plant biomass to enable the…
Artemis Position Statement on the EU Biotech Act For an Innovative and Sustainable Agricultural Policy in Europe Artemis, the Dutch association for natural crop protection, welcomes the European Commissions initiative for a comprehensive EU Biotech Act.
Summary of Annex: The proposed European Biotech Act can be a crucial turning point for biotechnology in Europe, provided that it is designed as a catalyst for innovation and not as a source of new bureaucracy. It is clear to Hamilton Bonaduz AG: Not additional funding programmes or Commission bodies will strengthen Europe’s location, but transparent, fast and innovation-friendly framework conditions.
Filed in German · English published by the European Commission
Regulatory barriers hindering innovation in precision fermentation: impact and recommendations: The EUs current regulatory framework for Novel Foods, specifically Regulation (EU) 2015/2283 and Transparency Regulation (EU) 2019/1381, presents significant challenges for companies developing precision fermentation products.
Our key points have been uploaded separately. About WACKER Biotech and WACKER BioIngredients Wacker Biotech focuses on contract development and manufacturing services (CDMO) for the pharmaceutical and biotech industries. It specializes in microbial production systems for the development and production of biologics, including nucleic acids, therapeutic proteins, vaccines, and live microbial products.
— not to forget the food industry, which also uses food biotech. There is real potential in Europe. — supporting scaling up is essential to be competitive – connecting ecosystems to facilitate infrastructure sharing (e.g.) – supporting innovations in SMEs and not just in start-ups. — avoid companies fleeing with their know-how and economic benefits.
Filed in French · English published by the European Commission
Biotechnology in the broadest sense of the term is the intersection of industrial and biological innovation. Given our focus on agriculture, I would like to suggest a number of areas that I see and I see as promising both from the point of view of research and, above all, of practical application. More and more, we will look for innovations that make agricultural production more efficient.
Filed in Czech · English published by the European Commission
· · filed 3 Jun 2025 · source
Argentina agrees with the aim of the proposal to use biotechnology as a key tool to improve competitiveness in the world and in particular in the EU. However, we believe that addressing trade barriers, especially regulatory barriers, which today limit the potential of agricultural biotechnology to contribute to food security and global productive sustainability, will be key to achieving this goal.
Filed in Spanish · English published by the European Commission
To boost the biotechnology and agri-food sector in the European Union, it is essential to further strengthen public-private partnerships, but also to step up the return of European talent operating outside the EU’s borders and to match the educational offer with the needs of the industrial fabric.
Filed in Spanish · English published by the European Commission
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 and targeted biocontrol.
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 represent 45 countries and include experts from academic, clinical, governmental and industrial environments.
· · filed 26 May 2025 · source
As a stakeholder in the automation of the biotechnology sector, the Fraunhofer IPT would like to draw attention to three key points regarding the European Biotech Act. Funding from a Production Perspective: Currently, funding policies often support research projects, but not projects regarding biotechnology's engineering and development aspects.
· · filed 23 May 2025 · source
Incentivize Impact-Oriented Research: The Act should prioritize and provide incentives for research that has a clear path to societal benefit and can reach the market quickly. This will ensure that innovation translates into tangible improvements for citizens as soon as possible.
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 biotechnology, particularly biocontrol, must be recognized as a cornerstone of Europes transition to sustainable and safe…
· · filed 20 May 2025 · source
This submission responds to the European Commissions call for evidence, focusing on AI's role in the Biotech Act. The Act must balance robust risk mitigation with innovation, especially in AI-driven medical/pharma and agronomy. 1.
STATEMENT MAY 2025 The Standing Committee of European Doctors (CPME) represents national medical associations across Europe. We are committed to contributing the medical profession’s point of view to EU and European policy-making through pro-active cooperation on a wide range of health and healthcare related issues.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
· · filed 19 May 2025 · source
The 5 main drivers identified by the Commission are certainly correct. The biotech sector in the EU could be very strong, but barriers are enormous. Risk capital is one of them, but the most important are regulatory hurdles. Regulators (or competent authorities) behave as camp guards and not as competent scientists. Each innovation is evaluated as a potential threat, not as a potential opportunity.
Filed in Dutch · English published by the European Commission
The European Biotech Act, as outlined in the European Commissions 20242029 political agenda, represents a historic step toward revitalizing and scaling the biotechnology sector across the European Union. Biotechnologyspanning medical, agricultural, industrial, environmental, and marine applicationsoffers unprecedented solutions to critical challenges in health, climate change, food security, and energy…
· · filed 18 May 2025 · source
Hello, the words are trafficked by the COM, using the word ‘biotechnology’ (‘gross value added of EUR 38.1 billion in 2022’), including any artisanal or industrial activity on food and medicine. It wants to promote biotechs (in agriculture and medicines). Normal, it is ‘progressive’, that is to say, it is _croit_ in progress. I do not believe in this, and the European citizens are less and less so.
Filed in French · English published by the European Commission
The biotechnology sector is a focal point for growth and development. It cannot be overlooked that it concerns critical points of concern from an ethical point of view and the safety of citizens’ health and therefore requires careful assessment. An assessment to overcome vetoes that are often placed under the precautionary principle often used ideologically
Filed in Italian · English published by the European Commission
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