EUROPEAN COMMISSION
Strasbourg, 16.12.2025
COM(2025) 1022 final
2025/0406(COD)
1.CONTEXT OF THE PROPOSAL
•Reasons for and objectives of the proposal
Biotechnology and biomanufacturing are essential to the EU’s competitiveness, strategic autonomy and economic security. They are a pillar of the Union’s societal wellbeing in key areas such as health and food.
This strategic importance is underscored by the sector’s rapid expansion. Over the last decade, the EU biotechnology industry has grown more than twice as fast as the overall EU economy and is one of the most economically productive industries. The spillover effect is also significant, each job in industrial biotechnology generates 3.4 additional jobs in the broader economy. In 2022, it accounted for EUR 38.1 billion of Union GDP and contributed to 913 160 jobs, with more than 75 % of those jobs (685 000) coming from the health biotechnology sector.[1]
However, the EU lags behind other global regions when it comes to translating its world‑class science and innovation into commercially viable products, and even more so in manufacturing such products at scale. Despite world‑leading biotechnology science, reflected by a publication record comparable to that of the US and China (Figure 1), the EU faces structural barriers in clinical development, regulation and manufacturing. As a result, too often Union start‑ups end up investing, growing, employing, creating value and placing their products on the market abroad rather than in the EU. This is especially true for health biotechnology, where it is at times challenging for the legislative frameworks to keep pace with the speed of scientific developments.
Figure 1: Top tier life science publications of the EU compared to the USA and China
To remain a biotechnology powerhouse, the EU must make the most of its scale. Fragmented governance and sub‑optimal coordination across Member States weaken the EU’s ability to deploy industrial facilities at scale, resulting in under‑used biomanufacturing potential – including in strategic areas such as biosimilars, where the EU has strong expertise but insufficiently exploited capacity. It should also ensure a strong alignment between the available labour supply and the specialised skills that the biotechnology and biomanufacturing sectors will require in the future. Current skill shortages across key areas including R&D, regulatory affairs, AI, and data analytics further hinder Europe’s competitiveness. At the same time, the widening gender gap and the untapped potential of a diverse workforce represent missed opportunities for innovation and resilience.
Access to finance for scale‑up funding in the EU remains limited compared to other regions. US biopharma start‑ups received around nine times more late‑stage funding than EU biopharma start‑ups, with around EUR 219 billion of venture capital focused on health biotechnology invested in the US compared to EUR 25 billion in the EU between 2015 and June 2025 (Figure 2). EU public equity markets for biotechnology also remain comparatively underdeveloped, with stock exchanges still largely fragmented across EU Member States.[2] As a result, many EU scale‑ups choose to list abroad: over the last six years, 66 out of 67 EU biotechnology companies that went public chose to list on non‑EU stock exchanges, illustrating the persistent structural disadvantages faced by EU‑based innovators.[3]
Figure 2: Health Biotechnology investment in the EU compared to the US and China
Aligned with the objectives of the AI Continent Action Plan and the Apply AI Strategy, the EU must also tap into the massive potential of AI for biotechnologies, addressing obstacles like limited testing environments, fragmented data, and exploiting the full potential of AI across the lifecycle of biotechnology products, in particular for medicines. Further, Regulation (EU) 2024/1689 (AI Act)[4], which entered into force in August 2024, lays down a uniform legal framework in particular for the development, the placing on the market, the putting into service and the use of AI systems and models in the Union, in accordance with Union values, to promote the uptake of human‑centric and trustworthy AI.
Biotechnology introduces new biosecurity risks as the wider accessibility of these technologies increases their potential for misuse, posing significant health threats. However, divergent or absent national rules on screening biotechnology products with significant potential for misuse, such as the synthetic DNA of dangerous pathogens, raise compliance costs, fail to offer a level playing field to competitors, and weaken prevention.
Fragmentation and the complexity of the EU regulatory framework are factors that make the EU less attractive for translating cutting‑edge research and innovation into marketable products. For instance, the global share of commercially sponsored clinical trials in the European Economic Area has declined from 22 % in 2013 to 12 % in 2023, while China’s share of commercial clinical trials rose from 5 % to 18 % in the same period, with the US share remaining considerably more stable.[5] Importantly, the overall reported decline in small‑molecule trials suggests a strategic shift toward the development of biological medicines at the expense of small‑molecule programs. The drop in the number of small‑molecule trials was the most significant in Phase II trials from 62 % in 2015 to 47 % in 2024 and in Phase III trials from 65 % to 53 % during the same period.[6] In particular, the EU is losing ground to other regions with increasingly agile regulatory and financial systems. Most of these regions issue decisions on validated clinical trial applications within 60 days, whereas in the EU it takes on average 113 days for multinational trials.
Highlight: the need to simplify and streamline the Clinical Trials Regulation (CTR)
Clinical trials in the EU are crucial to provide patients with early and equal access to innovative treatments, uphold scientific excellence, and support the EU’s long‑term competitiveness and prosperity. By attracting investment in research and development (R&D), creating jobs, and reducing healthcare costs, these trials deliver substantial economic and societal benefits. They also significantly benefit patients by providing earlier access to new therapies, including personalised therapies (e.g. for rare diseases and cancers), improving quality of life, and strengthening the evidence base for clinical guidelines, marketing authorisation and health technology assessments. The share of clinical trials with biological medicines seems to be increasing at the expense of low‑molecule trials. Biological medicines sales are key drivers of growth. In 2024, the European Union spent €228 Bn on medicines at list prices, including €95 Bn on biological medicines, which now comprise 41 % of total pharmaceutical spending. Increased clinical trials in the Union for biological medicines could potentially contribute to more manufacturing in the Union, higher number and earlier regulatory submission of biological medicines for marketing authorisation applications and a higher percentage of EU clinical data in marketing authorisation applications. A conducive environment for clinical trials is essential to speed‑up market access for novel medicines, especially against global competition. There are still significant regulatory fragmentations across Member States that limit the system’s efficiency. Against this background, further regulatory streamlining and simplification of the authorisation and conduct of clinical trials are imperative. This is a key point of the Draghi report on the future of European Competitiveness[7], which highlights the need to address these inefficiencies, stressing the importance of reducing regulatory delays and administrative burdens. It calls for harmonised templates, stronger coordination between national ethics committees, and a greater emphasis on using artificial intelligence (AI) and digital tools to streamline the process.
This is why a European Biotech Act was announced by the President of the European Commission in the 2024‑2029 Political Guidelines of the Commission[8], with the aim of creating an enabling environment to make it easier to bring biotechnology products from the laboratory to the factory and then onto the market, while maintaining the highest safety standards for the protection of the population and the environment. As previously acknowledged in the Communication on Biotechnology and Biomanufacturing (March 2024) and the reports by Enrico Letta[9] (April 2024) and Mario Draghi[10] (September 2024), it is necessary to address the challenges faced by EU companies, users and consumers to boost the EU’s technological advancement, competitiveness and economic growth. In its resolution ‘Future of the EU biotechnology and biomanufacturing sector’[11], the European Parliament recommended ‘facilitating a fast and efficient uptake of biotechnology and biomanufacturing through clear regulatory frameworks’. The European Parliament is now preparing an own‑initiative report on ‘Public health aspects of biotechnology and life sciences’[12]. More recently, EU Member States urged the Commission to unlock the potential of biotechnologies, by reducing fragmentation and simplifying the EU regulatory framework across policy areas[13].
Given the importance of health biotechnology amongst the other applications of biotechnology as, it is appropriate that the European Biotech Act focusses on, and sets out specific measures for, the health dimension of biotechnology. To ensure the effectiveness of this proposal, its scope of application extends to health biotechnology in a comprehensive manner and cover health within the wide meaning of Article 168 of the Treaty of the Functioning of the European Union (TFEU) on the protection of public health. In this regard, Article 168(1) TFEU emphasises that a high level of human health protection is to be ensured when defining and implementing all Union policies and activities. Article 168(4) TFEU clarifies that this objective is, amongst others, to be pursued through measures setting high standards of quality and safety for medicinal products and devices for medical use and of organs and substances of human origin, blood and blood derivatives, measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health. Accordingly, and in line with the One Health approach, this Regulation should apply to health biotechnology, understood as the application of biotechnology in the human medical, veterinary, pharmaceutical and phytosanitary areas for the development of biotechnology products and services. The Regulation should apply to their entire lifecycle, including the related research, access to funding, development, innovation, testing, validation, manufacturing, placing on the market and use activities.
The proposal for a European Biotech Act acknowledges the EU’s potential to be a global leader. The region combines a highly skilled workforce, world‑class scientific institutes, innovative startups and scale‑ups, advanced infrastructure and large private capital pools that could be used to support the domestic scale‑up of promising companies. The proposal therefore seeks to address the barriers hindering the development of the EU’s health biotechnology sector, starting from early‑stage research through to later‑stage deployment and scale‑up. It introduces facilitation measures in the health biotechnology areas, including a framework for the recognition of, and support for, health biotechnology strategic projects and high impact health biotechnology strategic projects, aimed at reducing time‑to‑market, with particular attention paid to the needs of small and medium‑sized enterprises (SMEs), and includes future‑proofing provisions to anticipate the needs of health biotechnologies. Acting decisively now will allow the EU to fully harness its fast‑moving biotechnology sector, reinforce strategic autonomy and economic security, and lay the foundations for a competitive and forward‑looking EU biotechnology sector.
With a view to ensure the effectiveness of the substantive provisions put forward in this proposal, amendments to Union legislation in the areas of health and food and feed safety are also established for regulatory simplification, that have an impact on innovation and the time to market for biotechnology products and services, including where such legislation also applies to products other than biotechnology products. In this regard, without an efficient, accelerated and streamlined legislative framework for clinical trials in the Union, the other measures in this Regulation, and in particular the framework for the recognition and support of health biotechnology strategic projects and high‑impact health biotechnology strategic projects would be deprived of their effectiveness, as all health biotechnology medicinal products require state‑of‑the‑art clinical research and a globally competitive regulatory framework for clinical trials authorisation. Similarly, a timelier risk assessment process for products subject to pre‑market authorisation in accordance with Union food and feed legislation, including for biotechnology innovations where pre‑submission advice of the European Food Safety Authority for aspects such as study design is paramount, as well as accelerated procedures are needed for the effectiveness of the substantive facilitation measures put forward in this proposal.
In a second stage, following this health‑focused initiative, the Commission will address in 2026 the wider biotech ecosystem beyond health to ensure a competitive internal market for all areas of biotechnology.
Figure 3: Biotechnology and biomanufacturing sector in Europe, problem tree
•Consistency with existing provisions in the policy area
The European Biotech Act will seek to streamline the relevant EU legislative frameworks to create an enabling environment for innovation and development in order to accelerate time to market. With its primary focus on health, the present proposal will amend the Regulation on clinical trials (CTR)[14], the Regulation on advanced therapy medicinal products (ATMPs)[15], the Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO)[16] and the Regulation on veterinary medicinal products (VMPs)[17]. In the field of food safety, the proposed measures are built on the General Food Law[18]. The proposal will also amend the legislation on the deliberate release of genetically modified organisms (GMO)[19].
The proposal also considers other existing legislation that is being revised to ensure the coherence of the overall EU regulatory system, in particular the Regulation on medical devices (MDR) and the Regulation on in‑vitro diagnostic medical devices (IVDR)[20], as well as the proposed simplification measures in food and feed safety legislation (food and feed simplification package).
The Biotech Act will also exploit synergies with other EU legislation. It will complement the Critical Medicines Act (CMA)[21] to strengthen EU‑based biotechnology research and manufacturing. The Act is also in line with the pharmaceutical strategy for Europe[22] and complements the ongoing revision of the EU pharmaceutical legislation[23] to create the appropriate conditions for biotechnology from the innovation stage. Moreover, the proposed measures are complementary to the proposed regulation on plants obtained by certain new genomic techniques and their use in food and feed.
•Consistency with other Union policies
As one of the flagship initiatives of the Competitiveness Compass[24], the proposed Biotech Act aligns with the EU’s broader innovation and competitiveness agenda, translating the priorities of the Compass into concrete actions within the strategic sector of biotechnology.
In particular, the Biotech Act is part of the Commission’s life sciences strategy[25]. It was presented as a central instrument to strengthen the Union’s biotechnology ecosystem, streamline regulatory procedural pathways and boost Europe’s competitiveness in life sciences, recognising biotechnology as a strategically critical and cross‑sectoral technology.
Furthermore, the proposed Act is complementary to the other policy initiatives announced in the Compass. First, it aims to improve access to later‑stage capital for biotechnology firms, aligning with the start‑up and scale‑up strategy[26] and complementing the Scale‑up Europe Fund established under that strategy, as well as the Savings and Investments Union[27], which seeks to mobilise larger pools of private capital, support investment within the EU, and reduce financing costs for Union businesses.
Second, the provisions on biosecurity also reflect the Compass’s emphasis on talent as a cornerstone of innovation and on the interdependence between economic strength and security. In this context, the Act is consistent with the objectives put forward in the Union of Skills[28] and contributes to EU security by reinforcing safeguards for dual‑use biotechnologies. It also complements the EU Regulation (EU) 2022/2371 on serious cross‑border threats to health[29], helping to ensure a coordinated Union‑level response to health risks that may arise from the misuse of emerging biotechnologies and to the strategic technologies for Europe platform (STEP)[30] that also target biotechnologies.
Third, the emphasis on the use of AI in the proposed Act also aligns with the Competitiveness Compass, and echoes the recent Apply AI strategy[31], the AI continent action plan[32], the European AI Act[33] and the Data Union strategy[34], which stress the need to strengthen Europe’s innovation capacity, technological competitiveness and secure, data‑driven ecosystems while supporting the biotechnology landscape.
Overall, the Biotech Act is also consistent with the vision for agriculture and food[35]. It amends the General Food Law to broaden the scope of pre‑submission advice provided by the European Food Safety Authority (EFSA) to study design, and reforms the EFSA Panel system to speed up risk assessment procedures.
Finally, the proposed Act was informed by the preparation of upcoming and recent initiatives, such as the future European Innovation Act[36] and the recently adopted bioeconomy strategy[37], in order to ensure synergies.
•Climate and sustainability considerations
Furthermore, climate change has shown the need to also prioritise the resilience of the Union, including, for instance to focus on sustainable food systems, stronger health prevention and innovative health solutions. In this context, biotechnology has been identified in the Farm to Fork Strategy[38], which is a key component of the European Green Deal[39], as a technique that is safe for consumers and the environment. The proposed Act is also consistent with the European Commission’s objectives to achieve climate neutrality set out in the EU Climate Law[40] and the Union’s Strategy on Adaptation to Climate Change[41].
In this context, the proposed European Biotech Act, including through its measures supporting innovation, will accelerate the placing on the market of biotechnology products that are adaptable to climate change, that contribute to health and food security through sustainable biomanufacturing and to the protection of biodiversity. Such biotechnology products have also the potential to replace products potentially more harmful for the environment while providing great benefits for consumers and users. Biotechnology and biomanufacturing will also need to comply with Union legislation in these areas, such as, the Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)[42] or applying without prejudice to the provisions of Regulation (EU) 2024/1735 regarding sustainable biogas and biomethane technologies and biotechnology climate and energy solutions[43].
This also shows that the proposed Act is in line with the ‘do no significant harm’ principle. The positive environmental impact of biotechnology and biomanufacturing was also recognised by stakeholders in their responses to the Public Consultation.
•Digital transformation
Finally, the proposed Biotech Act will support digital transformation in line with the ‘digital by default’ principle. One of its specific objectives is to “facilitate the application of AI into the Union’s biotechnology and health technology manufacturing ecosystems and frameworks, in line with Regulation (EU) 2024/1689”. The Act is expected, among others, to support the use of data, digital platforms and analytical methodologies (e.g. reducing the need for clinical data), in the development of biotechnology and in biomanufacturing. Digitalisation will also be reinforced in networking cooperation of biotechnology clusters (e.g. through the promotion of the development of infrastructure and digital platforms, and AI‑enabled technologies). Overall, accelerated digitalisation, in particular through greater data use and AI integration, aims at contributing to the Union’s technological sovereignty.
Moreover, the proposed European Biotech Act will ensure coherence with relevant digital policies, such as the Artificial Intelligence Act[44], on development and testing of AI enabled biotechnology solutions, and the EU Cybersecurity framework[45], on access principles and security safeguards.
2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
•Legal basis
The general objective of this Regulation is threefold: (i) to improve the functioning of the internal market by establishing a framework to strengthen the competitiveness of the health biotechnology sector, from research to production, (ii) to create the conditions for the development and timely placing on the EU market, of biotechnology innovations, products and services, (iii) while safeguarding high standards for the protection of human health, animal health, patients and consumers, the environment, ethics, quality, food and feed safety, and biosecurity.
This general objective translates into the establishment of measures to: (i) strengthen the biotechnology sector and reinforce the EU’s research, development and production capabilities, by establishing a framework for the recognition of, and support measures for, strategic health biotechnology projects and high‑impact strategic health biotechnology projects (pillar 1); (ii) support funding of, investments in, and access to capital for, biotechnology companies and projects, including through the setting up of an EU health biotechnology investment pilot to fill the gap in spending on biotechnology innovation (pillar 2); (iii) improve the EU manufacturing capacity of, and expertise in, biosimilars, including through international cooperation (pillar 3); (iv) facilitate the application of AI into the Union’s biotechnology and health technology manufacturing ecosystems and frameworks, in line with the Regulation (EU) 2024/1689 (pillar 4); (v) ensure a legislative framework that encourages innovation and takes account of technological and scientific developments and progress, by establishing provisions for health biotechnology products (pillar 5); (vi) prevent the misuse of biotechnologies and strengthen biodefence capabilities (pillar 6). (vii) enable the effectiveness of the measures under the pillars 1 to 6 through a legislative framework conducive to the use of biotechnology innovations, by amending Union legislation in particular on clinical trials, veterinary medicinal products, food and feed safety and related legislation (pillar 7).
The appropriate legal basis is therefore as follows: – Article 114 of the Treaty on the Functioning of the European Union (TFEU) which allows the EU to take measures that increase harmonisation and remove fragmentation to create a level playing field within, and fully exploit the scale of, the EU single market, so that the health biotechnology and biomanufacturing sectors can thrive. In accordance with Article 114(3) TFEU, the proposal seeks to achieve the objective of a high level of health and safety protection. – Article 168(4) TFEU, which mandates the Union to contribute to the achievement of a high level of human health protection through the adoption – in order to meet common safety concerns – of (i) measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; (ii) measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health; and (iii) measures setting high standards of quality and safety for medicinal products and devices for medical use. – Article 173(3) TFEU, which allows the Union to decide on specific measures in support of action taken in the Member States to ensure the conditions necessary for the competitiveness of the Union’s industry, excluding any harmonisation of the laws and regulations of the Member States. This article provides a legal basis for the provisions in this Regulation regarding the EU health biotechnology investment pilot, establishing the basis for future Union financial support together with implementing partners, to support the financing of, and investments in, companies and projects falling within the scope of the European Biotech Act.
•Subsidiarity (for non‑exclusive competence)
The objectives of the proposal cannot be achieved by Member States acting alone, as the issues tackled are of a cross‑border nature and are not limited to single Member States. The proposed actions focus on areas where there is a demonstrable value added in acting at EU level due to the scale, speed, and scope of the efforts needed.
Furthermore, the market drivers identified are shared across the Member States, affecting the functioning of the single market and the global competitiveness of EU companies. Access to finance is scattered across the EU and EU companies lack the capacity to access private finance at a competitive scale, including at later stages of development. Similarly, European biotechnology clusters are scattered across the EU, without sufficient continental scale to compete globally. The development and deployment of AI solutions for biotechnology remains limited, also due to the low level of storage, access and sharing of data relevant for biotechnology in the EU, including across borders. There is also a clear need across the EU to attract, reskill and upskill the workforce.
Moreover, while several Member States have taken action to boost innovation in biotechnology, the above‑mentioned bottlenecks persist; improvements are expected to take considerably more time and without achieving the levels needed to compete at global level. For example, access to finance would remain scattered at EU level. The growth of clusters in the EU would also remain limited, without sufficient benefits from cross‑border connections.
Lastly, important regulatory barriers faced by European biotechnology companies stem from EU legislation. Therefore, with a view to enable the effectiveness of the substantive measures put forward in this proposal, it is proposed to simplify EU legislation in the area of health and of food and feed safety to make it easier to innovate and place biotechnology products and services on the Union market and to enhance legal clarity.
•Proportionality
The selected measures under the industrial policy and substantive part of the proposal are targeted at the specific areas of interventions listed below. – The provisions on strategic health biotechnology projects and high‑impact strategic health biotechnology projects are proportionate to the aims pursued, including by recognising the first category of projects at Member State level, and the second category at EU level on the basis of an assessment at Member State level. Moreover, the recognition of such projects is based on clear criteria tailored to ensure that projects that contribute substantially to the Union’s competitiveness, resilience, and security fall within the enhanced support regime. Moreover, the recognition of such projects does not restrict Member States’ ability to support additional projects through other instruments. Member States benefit from flexibility as regards the authorities that they intend to designate to recognise strategic health biotechnology projects and assess applications for high‑impact strategic health biotechnology projects. This flexibility also applies to the single points of contact and the provision of administrative, technical, and financial support, in line with Union law and the national systems. Accelerated permitting timelines apply only to recognised projects and are designed to streamline procedures without lowering any environmental, health or safety standards.
Similarly, measures aimed at supporting networking among health biotechnology clusters are limited to what is necessary to foster synergies in the internal market, while the EU Health Biotechnology Support Network is aiming to build on and complement existing national and EU structures, avoiding any duplication.
– On access to funding, the interventions focus on measures mobilising public funding and private capital; public funding needs to be in line with State aid rules.
– The proposed interaction modalities with Member States in the context of a European Health Biotechnology Steering Group allows for priorities to be adjusted, including by ensuring that the support measures for strategic health biotechnology project and high‑impact strategic health biotechnology projects remain closely aligned with the Regulation’s general objective.
– The proposed amending provision aimed at reducing the time‑to‑market of biotechnology products and services focus on certain sectoral Union legislation where room for simplification of regulatory and administrative complexities has been identified. Simplification relates to changes that are necessary with a view to secure the effectiveness of the substantive provisions put forward in this proposal and will improve the legal clarity, certainty, and overall efficiency of the concerned EU legislative frameworks.
•Choice of the instrument
The proposal takes the form of a regulation of the European Parliament and of the Council. A regulation is the most suitable legal instrument for Pillars 1 to 4, given the need for a uniform application of the new rules, in particular the conditions and procedure for recognising health biotechnology strategic projects and high‑impact health biotechnology strategic projects, and for their administrative, technical and financial support, and also more broadly for companies and non‑profit organisations active in the relevant biotechnology sectors across the internal market. This is also the case for Pillar 5, regarding the provisions on biotechnology health products, given that they aim to ensure a dialogue and more flexibility across the Union legislative frameworks in the area of health. The choice of a regulation as a legal instrument is also appropriate for Pillar 6 because only a regulation, with its directly applicable legal provisions, can provide the necessary degree of uniformity needed to boost EU biodefence and biosecurity and prevent biotechnology misuse.
In all cases, the choice of the instrument is justified considering that the Pillar 7 establishes provisions amending several existing Union regulations in the area of health and food and feed safety.
3.RESULTS OF EX‑POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
•Ex‑post evaluations/fitness checks of existing legislation
The proposed measures amend several pieces of EU legislation in a targeted manner, without modifying their objectives, the overall regulatory framework put in place or their functioning. When relevant, these measures were informed by several studies or ongoing evaluations, such as the ongoing evaluation of the EFSA. Regarding the Clinical Trials Regulation, an ongoing study will contribute to the Commission’s report, which will be presented five years after the application date of the legislation (1 January 2022).
The extensive consultation process and a comprehensive supporting study identifying over 200 regulatory challenges stemming from EU legislation have gathered evidence on the challenges and problems, the relevant provisions of the legislation, and issues for which there is no legislation.
•Stakeholder consultations
Extensive stakeholder consultations were carried out to prepare for the proposal. A call for evidence, opened for feedback from 14 May to 11 June 2025, gathered 222 valid individual contributions from a wide range of stakeholders: business associations (63), companies (50), non‑governmental organisations (NGOs) (44), academic and research institutions (20), public authorities in the EU (14), EU citizens (14) and other categories (17).
Figure 4: submissions to the call for evidence
The respondents were largely based in the EU (197 responses from 15 Member States). Among these, most of the contributions came from Belgium (74), followed by Germany (29), France (20), the Netherlands (16), Denmark (12) and Spain (11). 25 contributions were received from 7 non‑EU countries (the United States, Switzerland, the United Kingdom, Norway, Canada, Australia and Argentina).
With regard to current biotechnology‑related regulation, various stakeholder groups such as academic/research institutions, NGOs, representatives of companies (including SMEs), and public authorities underlined slow and complex regulatory frameworks that lead to long authorisation/approval processes, thereby hindering innovation and delaying market access. Representatives from businesses (both associations and large companies) referred to the unpredictability of some authorisation procedures. Representatives from academic/research institutions and business associations also expressed concerns regarding outdated regulatory frameworks, while business associations mentioned in particular the limited flexibility of the EU regulatory frameworks. In addition, NGOs/others, large companies and SMEs, business associations and trade unions agreed that divergent national rules and interpretation/implementation of EU rules create fragmented market entry conditions. Feedback from small companies indicated high regulatory costs as a result of the regulatory fragmentation, while public authorities also acknowledged high compliance costs. Lastly, some feedback pointed to inconsistencies between EU legislative frameworks, in particular the CTR, ATMPs Regulation, MDR/IVDR, REACH Regulation and the General Data Protection Regulation (GDPR).
Most stakeholders also indicated a shortage of risk‑tolerant capital. Stakeholders highlight fragmented funding schemes, limited early‑stage financing, and low EU venture capital share compared to the US and China. For instance, representatives from academic/research institutes indicated that the EU’s venture capital accounted for only about 5 % of global venture capital. Representatives of large companies particularly underlined public R&D under‑investment, indicating poor alignment across policies and programmes. Some contributions from NGOs/others also indicated the risk of dependence on foreign capital, particularly in health and defence‑related biotechnologies.
Stakeholders stressed the fundamental role of education and skills for the biotechnology and biomanufacturing workforce. Stakeholders expressed concerns about talent drain and global competition. This is exacerbated by existing regulatory and mobility barriers that hamper cross‑border and cross‑sector mobility, as indicated in feedback from academic/research institutions. In addition, stakeholders underlined the limited entrepreneurial pathways from academia to company building. Moreover, many stakeholders experienced shortages in the specialised and interdisciplinary competences needed for the biotechnology and biomanufacturing workforce. Other limitations mentioned were an insufficient number of STEM graduates, the lack of funding or low investment in life‑long learning (e.g. digital, AI competencies), and unequal access to upskilling programmes.
Stakeholders across all groups (including academic/research institutions, business associations/trade unions, large companies, citizens, as well as NGOs/others and public authorities) stressed the limited manufacturing capabilities in the Union. Some of the underlying factors mentioned were, among others, the high costs, infrastructure and investment gaps, limited digitalisation, supply chain vulnerabilities, and the fragmented regulatory frameworks. SMEs underscored this statement, also pointing to the challenges related to lack of recognition for quality control technologies.
Furthermore, incubation and acceleration limitations in the EU were mentioned. Many stakeholder groups, such as academic/research institutions, large companies, NGOs/others and public authorities, highlighted the need to bridge the gap between research and industry in Europe’s biotechnology ecosystem. They expressed concerns on the barriers faced in incubation and acceleration, such as funding gaps in early stages, a fragmented support landscape, regulatory burdens, hindrances in public‑private collaboration and cultural/skill barriers. Business associations’ and public authorities’ feedback was in line with this statement, underlining that the EU lacks cohesive pathways to commercialisation. Large companies specifically pointed out the lack of financial and administrative capacity of SMEs and start‑ups to access EU‑level funding or to protect their intellectual property.
Stakeholders overall recognised the pivotal role of AI and data to advance biotechnology. As part of the challenges faced however, academic/research institutions and large companies indicated a lack of access to data and secure data sharing, fragmented data ecosystems including limited data interoperability, unclarity on data governance and insufficient coordination. Business associations and public authorities also mentioned fragmented computing power and uneven access to testing infrastructures. Furthermore, SMEs referred to a lack of information and knowledge among companies about AI implementation and compliance. Feedback from NGOs/others overall echoed these statements, while also advocating to take into consideration the environmental impact of AI infrastructures.
Finally, on biosecurity, stakeholders mentioned that while biotechnology and biomanufacturing offer transformative opportunities across multiple application areas, these must be governed by policies that balance innovation with safety, equity, and environmental protection. Various challenges were pointed out by different stakeholder groups in relation to biosecurity. For instance, academic/research institutions, NGOs and public authorities mentioned a fragmented biosecurity governance and regulatory complexity as major issues. Specifically, disjointed EU and national regulations that hinder coherent biosecurity frameworks were highlighted. Public authorities furthermore indicated limited collaboration as a key challenge – for instance gaps in cooperation between national authorities and limited cross‑border collaboration. Regarding nucleic acid screening, academic/research institutions, and NGOs mentioned inconsistent compliance in screening due to current voluntary systems as a threat to biosecurity. Finally, dual‑use risks were mentioned by SMEs and NGOs.
A public consultation was carried out from 4 August to 10 November 2025. A total of 359 contributions were received. No duplicates or campaigns were identified. The contributions considered for the analysis were submitted by 91 companies/businesses and 61 business associations, 47 NGOs, 44 academic/research institutions, 54 EU citizens and 9 non‑EU citizens, and 21 public authorities. A further 2 contributions were submitted by 2 trade unions, 2 consumer associations, and 1 by an environmental organisation, while 27 additional respondents identified themselves as ‘Other’.
Figures 5 and 6: submissions to the public consultations and industry submissions per company size
Concerning the industry sector, most of the contributions came from SMEs (53 in total out of which 12 medium‑, 17 small‑, and 24 micro‑sized SMEs) and 38 contributions came from large enterprises. Of the contributing public authorities, 8 had a national remit and 8 had a regional scope, 2 of them were local authorities and 3 were international organisations.
As part of all contributions received, 16 respondents identified as private investors, including 13 from the EU and 3 from outside the EU (Switzerland and the United Kingdom). Most of them identified as company/business. When asked about the type of investment they provided, 8 stated that they provided ‘Venture capital’, 5 chose ‘Business Angel’, 4 ‘Private equity’, 3‘Corporate Venture Capital (CVC)’, and 1 ‘Other’.
Lastly, 43 respondents of all contributions received indicated being part of a cluster or of a cluster organisation. These represented 26 companies/businesses, 15 business associations, 1 NGO and 1 ‘Other’.
There is a strong overall interest from stakeholders to the biotechnology sector and acknowledgment of its great potential, in line with the EU’s economic, social and environmental policy goals. More precisely, a strong majority of respondents agreed that biotechnology and biomanufacturing products could positively impact the EU’s economy and the society, also recognizing its contribution to the environment[53]. Respondents considered biotechnology and biomanufacturing products that reached the EU market to be safe and secure[54]. However, they did not consider that information to users and consumers[55] on biotechnology and biomanufacturing products in the EU was sufficiently accessible and broadly communicated. Moreover, only a minority of respondents were willing to pay a price premium for such products[56].
Answers to the public consultation on the EU regulatory framework were in line with the focus of the proposed Act. The main regulatory barriers[57] identified by stakeholders concerned the assessment and obtaining authorisation to market products, followed by the pre‑commercial testing or clinical trials stage, in commercialising products as well as in the scaling‑up production or manufacturing and product development.
Another finding of the public consultation relates to the perception of the EU regulatory environment compared to that of some countries outside the EU. The EU regulatory environment is perceived by some stakeholders to have a lower level of predictability[58] and it is also seen as more complex and unclear[59], leading to more compliance costs[60] and slower access to the market[61]. Views on whether the EU regulatory environment ensures a higher level of safety and security were rather mixed[62]. Public authorities (57,9%, 11/19), NGOs (46,5%, 20/43), other stakeholders (48,5%, 15/31) and academic/research institutions (42,9%, 18/42) had a positive stance.
These findings underscore the urgent need to take action to simplify and streamline the regulatory environment, making it flexible and innovation‑friendly so that biotechnology products and services can reach the EU market more quickly.
Furthermore, respondents reported low level of access to private investments in the EU, in particular in accessing to publicly listing, private equity, debt financing, venture capital (VC) across series B (expansion stage) and C (growth stage) and capital markets/shareholders[63]. It should be noted that stakeholders also expressed low level of accessibility to some public funding, especially for support for capacity expansion, debt/equity instruments, and commercialisation support[64]. Stakeholders indicated less difficulties in accessing strategic research or sales partnerships/collaborations, angels, venture capital at start‑up/early‑stage (series A) and corporate funding[65] and public grants and subsidies[66].
When asked about the factors driving forward investments in a biotechnology company, there were no major differences in the answers. Some factors scored highly, which are (i) groundbreaking technology; (ii) regulatory certainty; (iii) innovative science; (iv) scientific evidence; (v) experienced management team; (vi) sufficient protection of intellectual property rights[67].
On clusters, the five main barriers faced by EU biotechnology clusters and/or cluster organisations preventing them from reaching their full potential were identified as: (i) insufficient financial support; (ii) insufficient public support; (iii) incapacity to reach a critical mass of stakeholders; (iv) insufficient start‑up incubators or business support infrastructure; and (v) insufficient collaboration among existing clusters[68].
Stakeholders identified the main challenges impacting the EU biomanufacturing sector as: (i) global competition; (ii) length and/or complexity of permitting processes for new facilities; (iii) difficulty of scaling up from pilot to industrial production; (iv) high energy costs; and (v) the high cost of raw material and/or of the operations[69]. A majority of respondents also agreed that major challenges are also posed by the inconsistent environmental and sustainability policies, vulnerabilities in the supply chains and other operational costs[70].
The public consultation also confirmed the challenges faced by the EU workforce. Stakeholders’ views were aligned on three main challenges: (i) the limited financial, entrepreneurial skills and mindsets; (ii) the insufficient regulatory and quality assurance expertise; and (iii) the shortage of vocational skills[71].
Some stakeholders indicated having difficulties accessing or using data for the development of biotechnology or biomanufacturing products[72]. Stakeholders also emphasised that technological challenges and challenges in the implementation of regulatory frameworks were the main barriers to both the use of AI in R&D[73] and to the deployment of AI‑based biotechnology products[74].
When asked about the types of support needed for biotechnology companies, in particular for SMEs, stakeholders stressed (i) skills development and AI training; (ii) access to annotated datasets; (iii) partnerships with public research institutions or AI hubs/factories; (iv), dedicated funding instruments; and (v) regulatory sandboxes for testing biotech‑related AI models[75].
When it comes to the application of biotechnology in defence and security, the main challenges identified by stakeholders were: (i) the risks to strategic autonomy in biomanufacturing (and availability of medical and non‑medical countermeasures); (ii) cybersecurity risks to biotechnology infrastructure and AI tools used in biotechnology; (iii) vulnerabilities in the resilience of biotechnology supply chains; and (iv) threats related to biosecurity and biosafety including misuse of biotechnology[76]. The four main opportunities that biotechnology for defence and security were creating were: (i) to develop new innovative medical countermeasures; (ii) to facilitate detecting biological and chemical threats, (iii) to increase food security; and (iv) to develop materials with new functions and / or improved characteristics[77].
In addition, targeted consultation activities were carried out, as detailed below, including in the context of an external study announced in the Commission Communication ‘Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU’ (Action 1)[78].
First, the following consultation activities took place on the analysis of regulatory problems and challenges faced by the biotechnology sector and on the mapping of applicable EU and national legislations to biotechnologies: •survey for public authorities; •survey for other stakeholders, including industry representatives and patient organisations; •interviews with representatives of SMEs and large enterprises, and representatives of the spin‑off, alliance/platform, scale‑up and EU association sectors; •five thematic workshops covering (i) health/pharma; (ii) agriculture/environment; (iii) food and feed; (iv) bio‑based chemicals and plastics; and (v) bio‑based materials.
Second, to analyse the impacts of identified policy provisions, evidence was collected on the impacts of these provisions. On clinical trials, evidence has been collected (by November 2025) through: •three workshops organised by the European Commission in June, September, and November 2025[79], with representatives of national competent authorities and ethics committee members from across the EU to exchange views with experts to inform how policy options would be defined; •targeted interviews; •targeted survey to various stakeholder groups: – a survey targeted to sponsors and clinical research organisations received 48 responses[80]; – another targeted survey collected views from 44 public authorities representing 25 EU/EEA countries[81]; – a survey tailored to patient representatives received 1 response from a disease‑specific patient representing an organisation at national level.
Evidence on the impacts of options on genetically modified microorganisms was collected through 25 interviews (by November 2025).
Finally, targeted consultation activities were also conducted as part of the supporting study for the evaluation of EFSA.
4.BUDGETARY IMPLICATIONS
Without prejudice to the outcome of the negotiations on the next Multiannual financial framework (MFF) proposal, strategic health biotechnology projects and high‑impact strategic biotechnology projects may be supported by Union programmes, funds and instruments, in accordance with the objectives set out in the regulations establishing those funds and programmes. A contribution is expected to come from the “health, biotechnology, agriculture and bioeconomy” window under the European Competitiveness Fund which, according to the proposal of the Commission, would receive a total allocation of EUR 20.4 billion over the MFF 2028‑2034. Two agencies, EMA and EFSA are proposed to be reinforced in staff and financially to conduct tasks related to these projects. The necessary financial resources will be compensated from applicable programmes under the agencies' headings in the 2028‑2034 MFF and where possible by additional income to be generated from third parties. The Legislative Financial and Digital Statement (LFDS) also presents estimated budgetary impact under Heading 4 including related human and administrative resources.
5.OTHER ELEMENTS
•Implementation plans and monitoring, evaluation and reporting arrangements
In the short term, implementation will focus on completing the strategic mapping of the Union’s biotechnology ecosystem within six months of the Regulation’s entry into force, and on setting up the new governance and support structures, including the EU Health Biotechnology Support Network, the Foresight Panel for Emerging Health Innovation and the European Health Biotechnology Steering Group. To support Member States in implementing the Regulation, to promote a uniform application of the Regulation and to clarify technical or operational elements where needed, the Commission may issue guidance on specific matters, including the criteria and procedures for recognising strategic health biotechnology projects and high‑impact health biotechnology strategic projects, and the coordination between the EU Health Biotechnology Support Network and other relevant networks. Member States will be required to designate national single points of contact and begin applying the streamlined regulatory procedures.
Monitoring will rely on the strategic mapping as a continuous evidence base, complemented by regularly updated information on the list of strategic health biotechnology projects and high‑impact health biotechnology projects.
In the medium term, the strategic mapping of the biotechnology ecosystem will be updated periodically and used to inform project selection and guide the deployment of Union support. Five years after the Regulation’s entry into application, and every five years thereafter, the Commission will evaluate the Regulation’s effectiveness and impact, and report its findings to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.
•Detailed explanation of the specific provisions of the proposal
Chapter I – Subject Matter, Scope and Definitions
This Chapter sets out the subject matter of this proposal, which consists of measures that articulate its overall objective (i) to improve the functioning of the internal market by establishing a framework to strengthen the competitiveness of the biotechnology sector, from research to production, (ii) to create the conditions for the development and timely placing on the Union market, of biotechnology innovations, products and services, (iii) while safeguarding high standards for the protection of human health, animal health, patients and consumers, the environment, ethics, quality, food and feed safety, and biosecurity. This Chapter also specifies the scope of the proposal, which applies to health biotechnology products and services during their entire lifecycle, including related activities on research, funding, development, innovation, testing, validation, manufacturing, placing on the market and use. Finally, this Chapter establishes definitions for key terms used throughout the proposal, including ‘biotechnology’, ‘health biotechnology’, ‘biotechnology product’, ‘biotechnology service’ and ‘biomanufacturing’.
Chapter II – Union health biotechnology and biomanufacturing
... (content continues similarly for all chapters up to Chapter X – Final provisions) ...
6.CONCLUSION
The European Biotech Act aims to create a coherent, innovation‑friendly regulatory environment that strengthens the Union’s health biotechnology sector, ensures high standards of safety and security, and positions Europe as a global leader in biotechnology and biomanufacturing.
The news content has been shortened. Full text is available at https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:52025PC1022