EU Biotech Act | Dual-Use and Security Concerns
What is the EU Biotech Act?
The proposed Biotech Act will create a coherent, innovation driven, and security conscious legal framework that governs biotechnology and biomanufacturing across the European Union. This legislative initiative intersects with key domains such as health, agriculture, energy, sustainability, economic security, national security, and biosecurity.
As the United States, China, and other global powers intensify their investments in biotechnology, including synthetic biology, genetic engineering, and advanced biomanufacturing, the EU recognizes that its internal market must become more agile, harmonized, and strategically autonomous. The EU Biotech Act is positioned as the flagship instrument to achieve these objectives.
The legislative proposal is expected to be presented by the European Commission in 2026, but preparatory work is already under way. It will address the regulatory fragmentation that currently hinders competitiveness.
From a legal and regulatory standpoint, the Act is expected to confront and reconcile multiple layers of EU law that currently intersect in the biotech space. These include environmental law (such as the legislation on genetically modified organisms), medicinal product regulations, clinical trials legislation, intellectual property frameworks, and EU level funding instruments.
One of the key challenges to be addressed is the tension between innovation facilitation and precautionary legal principles, particularly in the context of genetic modification, synthetic biology, and dual use technologies. The new legislative architecture must avoid duplication and inconsistencies while promoting legal certainty for innovators and protecting public health, safety, and the environment.
Central to the proposed Act is the effort to streamline regulatory procedures across Member States, thereby eliminating bottlenecks that delay time to market for biotechnological innovations. Presently, the patchwork nature of biotechnology regulation in the EU impedes not only the efficiency of product development but also the legal predictability that investors and firms require. Through the EU Biotech Act, the Commission aims to enhance the single market for biotech by introducing centralized or harmonized procedures, possibly inspired by the regulatory models already employed in the pharmaceutical and medical devices sectors.
Crucially, the Act is anticipated to introduce mechanisms such as regulatory sandboxes (controlled environments where new biotechnological approaches can be tested under the supervision of competent authorities). These sandboxes will allow for early stage experimentation while preserving safety and oversight, making it easier for disruptive technologies to gain regulatory feedback and, ultimately, approval. This model reflects a broader trend in EU lawmaking to allow for adaptive regulation, particularly in fast moving technological domains.
For risk and compliance professionals, the dual use nature of biotechnology presents a particularly significant concern. Technologies such as gene editing, engineered viruses, or synthetic biological agents can have legitimate medical or industrial uses, but they may also be weaponized or misused. As such, the EU Biotech Act is expected to integrate biosecurity considerations, linking innovation policy with the EU’s broader security agenda.
The legislation will need to align with the EU’s Dual Use Regulation (Regulation (EU) 2021/821), and impose new obligations on research institutions, firms, and laboratories to report risks, establish internal compliance systems, and undergo audits or inspections. These requirements will elevate the role of risk and compliance officers, particularly those tasked with navigating the intersection of biosafety, cybersecurity, and national security.
The extraterritorial dimensions of the EU Biotech Act should not be underestimated. As with the EU Artificial Intelligence Act, there is a clear trajectory in EU legislative practice toward asserting regulatory influence beyond its borders, especially where fundamental rights, environmental protection, or public health are implicated. This means that non EU biotech firms operating in or trading with the European market will likely be subject to the Act’s provisions, either directly or indirectly through contractual obligations, import controls, or equivalency mechanisms. This creates an imperative for global firms to monitor developments closely and integrate EU biotech compliance considerations into their risk management frameworks early.
December 16, 2025 - We have the text, the proposal for the European Biotech Act
The full name is "Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)."
According to Article 20, the European Health Biotechnology Steering Group (‘the Steering Group’) is established to facilitate the implementation of this Regulation. It will be composed of representatives from all Member States and the Commission.
Article 1, Subject matter and scope.
1. This Regulation establishes a framework to strengthen the competitiveness of the health biotechnology sector in the Union. It creates and reinforces favourable conditions for health biotechnology as defined in Article 2(1), point (2), from research and development to the timely placing on the Union market and production of biotechnology innovations and products, while safeguarding high standards of protection of human health, patient safety and animal health, the environment, ethics, quality of products, food and feed safety and biosecurity.
2. This Regulation lays down measures regarding:
(a) the establishment of a framework for the recognition of, and support measures for, health biotechnology strategic projects and high impact health biotechnology strategic projects;
(b) novel health biotechnology products and regulatory sandboxes to support innovation and take into account technological and scientific developments and progress;
(c) the support to promoters of biotechnology projects, SMEs, start-ups and scale-ups and non-profit developers of biotechnology products, by establishing an EU Health Biotechnology Support Network;
(d) the support for funding of, investments in, and access to capital for biotechnology companies and projects;
(e) the enhancement of the manufacturing capacity of, and expertise for biosimilars in the Union, including through international cooperation;
(f) the application in a facilitated manner of advanced technologies, including AI in biological applications, into the Union’s health biotechnology ecosystems, while monitoring and mitigating, in line with the Union harmonisation legislation on AI, biological risks arising from the use of such technologies;
(g) the placing on the market in particular of health biotechnology products and biotechnology services in accelerated and streamlined procedures;
(h) the prevention of the misuse of biotechnologies and the strengthening of biodefence capabilities, without prejudice to, and in complementarity with, activities financed under any defence related Union funding programmes and instruments.
3. This Regulation applies to health biotechnology innovations and products and their ecosystem during their entire lifecycle, including related research, funding, development, innovation, testing, validation, manufacturing, placing on the market, and use activities.
4. The amendments to the Union legislation laid down in Articles 56 to 61 are not limited to health biotechnology products and activities, but also relate to the other products, services and activities that fall in the scope of that legislation.
5. This Regulation does not affect the application of Directive 2010/63/EU on the protection of animals used for scientific purposes and of Regulation (EU) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
6. This Regulation shall apply without prejudice to Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence.
7. This Regulation shall apply without prejudice to Regulation […][[Regulation on speeding-up environmental impact assessments -permitting regulation].
Important biosecurity measures and compliance obligations in CHAPTER VIII
Article 46, Prevention and reporting of biotechnology misuse
1. For the purpose of preventing and detecting biotechnology misuse, economic operators and online marketplaces shall report suspicious transactions, having regard to all circumstances and in particular where the prospective customer:
(a) is not clear about their identity or affiliations, or provides information that cannot be confirmed or verified, including inconsistent addresses or unverifiable company details;
(b) would not be expected, in the normal course of business, to place such an order, including where there is no link to life science research or biotechnology, or no plausible requirement for biotechnology products of concern;
(c) proposes an intended use that does not match their reported job role or institutional affiliation;
(d) requests unusual labelling or shipping procedures, including misidentification of goods on packaging or changes to the recipient’s name after the order has been placed but before shipment;
(e) proposes unusual methods of payment, including cash for high-value items, personal credit cards for institutional purchases, or payment through non-bank third parties, or offers unusually favourable terms including above market prices;
(f) requests unusual confidentiality conditions regarding the order, including with respect to their identity, the final destination or the destruction of transaction records;
(g) requests delivery to an address without a legitimate biotechnology business or research justification, including a residential address.
2. Economic operators and online marketplaces shall have appropriate, reasonable and proportionate procedures in place to detect suspicious transactions, adapted to the specific environment in which biotechnology products of concern are made available.
3. Each Member State shall set up at least one national contact point with clearly identified contact details, web form or other effective tool for the reporting of suspicious transactions of biotechnology products of concern. The contact point shall be part of or have direct links to law enforcement and national inspection authorities.
4. Economic operators and online marketplaces shall refuse a suspicious transaction. They shall report any suspicious transaction or attempted suspicious transaction within 24 hours of determining that it is suspicious. Reports shall include, where possible, the identity of the prospective customer and the facts that led to the suspicion and shall be addressed to the national contact point of the Member State where the transaction was concluded or attempted.
5. Where a biotechnology product of concern falls also under categories regulated under other EU legislation, to avoid duplication of reporting, where the transaction for that biotechnology product of concern has already been reported as a suspicious transaction under one legal framework, it shall not be reported again. Where in doubt, its intended use should be prioritised for reporting obligations, pursuant to Regulation (EU) 2021/821[ 159 ] and Regulation (EU) 2019/1148[ 160 ].
December 16, 2025, the proposal for the European Biotech Act.
October 20, 2025, Commission work programme 2026, planned timing of the Commission’s proposal for a Biotech Act: Q3 2026
In the Commission work programme (CWP), every initiative has:
1. A type (“legislative”, “non legislative”, “evaluation”),
2. A legal basis (here, Article 114 TFEU), and
3. An indicative timing (like Q3 2026).
When an item is marked “legislative”, it means the Commission intends to present a legislative proposal to the European Parliament and the Council during that quarter, in this case, between July and September 2026.
Note: We read Biotech Act II, not Biotech Act. But there is no record of a prior European Biotech Act I. The Commission has never before used “II” for an Act that has no predecessor. We believe (this is an opinion, not a fact) that the proposal for a Biotech Act of December 2025 will become the Biotech Act I, that focuses on health biotechnology measures. We expect Biotech Act II, covering non health biotech domains.
The fact: In the explanatory memorandum that comes with the proposal of December 2025, we read: "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."
This is an explicit Commission statement in the proposal, explaining that the current draft is the first action, and that a second legislative action covering other biotechnology sectors beyond health is expected in 2026.
The strategic tension between the European Health Data Space (EHDS) and the Biotech Act.
Two major legislative initiatives define the direction of policy in the biotech and health data sectors, the European Health Data Space (EHDS) and the proposed European Biotech Act. On the surface, these two initiatives appear complementary, both aiming to unlock the value of health related data for research, innovation, and policy. Yet a closer examination reveals that they follow two fundamentally different and potentially conflicting logics, rights based governance versus growth centric governance.
The tension between these logics reflects real world clashes between regulatory bodies, stakeholder communities, and ideologies within the EU institutions, and it has far reaching implications for the future of data governance and biotech innovation in Europe.
The EHDS follows a protection based logic similar to the one found in the General Data Protection Regulation (GDPR). The EHDS emphasizes the primacy of individual control over health data, especially in the context of sensitive data such as genetic, biometric, and medical records.
The EHDS creates a framework for the primary use of health data (in direct care and treatment) and a heavily regulated system for secondary use (research, innovation, and public health planning). It seeks to build trust in data sharing by foregrounding privacy, transparency, and consent, requiring that data reuse operate under robust safeguards, including data minimization, purpose limitation, and strict access controls.
This rights based architecture positions the EHDS as an extension of fundamental rights under Article 8 of the Charter of Fundamental Rights of the European Union, which guarantees the right to the protection of personal data. The EHDS prevents the commodification of health data, guarding against scenarios in which citizens lose visibility or control over how their sensitive data are used by corporations or public bodies. It is also designed to address growing concerns about data exploitation in AI driven health applications, where algorithmic opacity, bias, and commercial appropriation have become hot button issues.
In sharp contrast, the European Biotech Act follows a growth-oriented logic. Its core premise is that Europe's competitiveness in the global biotechnology sector is hampered by fragmented regulation, slow authorizations, limited access to capital, and burdensome ethical or environmental restrictions, particularly in relation to genomic technologies, genetically modified organisms (GMOs), and the secondary use of health data in AI research. The Act proposes to streamline biotech regulation, reduce administrative burdens for startups and innovators, and create a more permissive environment for public private partnerships and cross border data flows in research.
While the Biotech Act does not formally contradict the EHDS, its emphasis on regulatory agility and innovation friendly ecosystems introduces pressures to reinterpret or dilute the protective boundaries of health data governance.
Biotech stakeholders argue that the pace of biomedical innovation, particularly in synthetic biology, personalized medicine, and AI enabled diagnostics, demands simplified access to large scale, interoperable, real world health data sets, including genetic data. The Biotech Act appears to understand these calls by encouraging data reuse mechanisms that may lean on broadly interpreted public interest exemptions, potentially circumventing some of the consent based protections envisioned by the EHDS.
This tension is complicated by the institutional dynamics of EU policymaking. The EHDS and GDPR are legally anchored in a fundamental rights framework, while the Biotech Act emerges from an internal market and competitiveness logic. As a result, different regulatory cultures and enforcement logics are at play. The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have voiced concerns about secondary use regimes that could normalize data access without meaningful consent, warning of the erosion of hard won privacy protections. In contrast, industry groups and certain member states have emphasized the need to “unlock” the economic potential of health data, treating it as a strategic asset in the EU’s global competition with the United States and China.
The Biotech Act could create a parallel data governance architecture, one more favorable to commercial actors and faster moving than the EHDS’s rights centered system. This “dual track” EU data space, one protective but slow moving (EHDS), and one permissive but high risk (Biotech Act), could introduce legal uncertainty, and complicate compliance for institutions navigating both frameworks.
Several civil society organizations, academic commentators, and data protection authorities have begun to raise alarms. Some have characterized the Biotech Act’s logic as a form of regulatory opportunism, wherein the language of innovation is used to soften the normative force of GDPR era data protections.
The European Commission has signaled awareness of these frictions. Public statements emphasize the need for “data protection by design” in biotech innovation and for coherence between the EHDS and broader digital health initiatives. Yet, implementation will be the real test. we will know only after the delegated acts, the interoperability standards, the funding criteria for biotech accelerators, and the interpretation of public interest justifications for data access.
The tension between the EHDS and the Biotech Act is real, legitimate, and structurally embedded in the EU’s evolving data governance landscape. We hope this tension will produce a balanced, ethically sustainable innovation ecosystem. For now, the EHDS and the Biotech Act are following different routes, and the outcome will shape the future of health data and biotech in Europe for years to come.
How might the policy direction of President Donald Trump’s administration influence the evolving balance between the European Health Data Space (EHDS) and the European Biotech Act?
President Donald Trump has no direct power over EU legislation, but his administration's approach to global trade, tech sovereignty, health data regulation, and transatlantic relations may shift the environment in which EU decision making unfolds, and tilt the balance between data protection and biotech liberalization in Europe.
Under Trump, the United States is likely to adopt a strongly pro growth, deregulatory approach to biotech and health tech sectors. A push for U.S. biotech supremacy, combined with looser data controls, could make Europe appear relatively overregulated and less competitive.
This competitive pressure could empower pro industry factions within the EU, giving new rhetorical momentum to the Biotech Act. EU policymakers might fear losing ground to U.S. companies in areas like mRNA, gene editing, AI in diagnostics, and synthetic biology. There may be growing internal pressure to relax EHDS style constraints and adopt a “strategic autonomy” narrative that privileges biotech acceleration over stringent data protections.
Trump’s administration is likely to disengage from GDPR style thinking and may weaken or abandon commitments to privacy frameworks like the EU–U.S. Data Privacy Framework, especially if perceived as barriers to U.S. businesses. This would strain transatlantic data cooperation, further polarizing EU and U.S. models of health data governance.
In such a scenario, the EHDS’s rights based structure, which depends on enforceable safeguards and trust in third country data protections, could come under stress. Some EU actors may argue that since data localization within Europe is impractical for innovation, and since the U.S. cannot be relied on to uphold GDPR equivalent protections, the EU should adopt a new “innovation exceptionalist” model domestically, potentially weakening EHDS enforcement in favor of Biotech Act flexibility.
Trump may revive a militarized biodefense narrative that brands biotechnology as a strategic security asset, not just a health issue. His past statements about pandemic preparedness, biological threats from China, and control over supply chains suggest he may double down on biotech as a matter of national sovereignty.
This narrative could spill over into the EU. If Washington treats biotech innovation as a matter of geopolitical contest, Brussels may feel pressure to reorient its biotech governance toward strategic competitiveness. The Biotech Act, with its emphasis on agile regulation, AI deployment, and resilience, fits that strategic mold.
It is important to reiterate that no external political figure or administration will directly shape EU policy. We do not advocate for or against the European Health Data Space (EHDS) or the European Biotech Act. Our role is to explore the implications of these developments so that risk and compliance professionals can better understand the evolving landscape and prepare their organizations accordingly.
Understanding the European Health Data Space (EHDS)
The U.S. Intelligence Authorization Act: Biotechnology has become a geopolitical domain.
The European Union and the United States approach biotechnology from different angles. The EU accelerates innovation, commercialization, and biomanufacturing capacity. The U.S., through legislation such as the Intelligence Authorization Act for Fiscal Year 2026, integrates biotechnology into national security strategy, outbound investment screening, and supply chain protection.
The two systems regulate the same technologies with different objectives. Monitoring only one side produces an incomplete picture of the global environment. In risk and compliance, we may find that a biotechnology activity encouraged under the EU Biotech Act becomes restricted under U.S. national security rules, or vice versa. U.S. investment controls trigger European reassessments of strategic dependencies.
Biotechnology developments in the EU and the U.S. must be monitored in parallel. The two regulatory paths are diverging in method but converging in impact. One cannot assess risk, opportunity, risk or compliance by looking at only one side of the Atlantic.
S.2342 - Intelligence Authorization Act for Fiscal Year 2026
14 May 2025 - European Biotech Act, call for evidence from the Commission
The consultation strategy aims to ensure that all stakeholders concerned have an opportunity to express their views and share insights on the main challenges faced by the sector across the EU, the measures proposed, and their likely impact.
Stakeholders’ input will feed into the impact assessment for the future European Biotech Act.
The consultation is addressed to citizens, innovators, entrepreneurs, industry, financial institutions, investors/venture capitalists, researchers/research organisations, civil society (including consumer, patient and environmental organisations), other users of biotechnologies (e.g. farmers and foresters), trade unions, national and regional authorities, and any other stakeholders.
14 May 2025 - European Biotech Act, call for evidence from the Commission
31 March 2025 - The Commission launched a public consultation on upcoming EU Bioeconomy Strategy.
The Commission launched a public consultation on the upcoming EU Bioeconomy strategy. It marks a significant step forward in harnessing the opportunities of the bioeconomy to support European businesses and drive progress towards the EU’s environmental, climate and competitiveness objectives.
The new Bioeconomy Strategy, due for adoption by the end of 2025, aims to advance innovation and maintain the EU's leadership in the bioeconomy. It will propose actions to unlock the potential of bioeconomy innovations, so that they can reach the market, generating green jobs and growth.
The strategy will also focus on reinforcing circularity and sustainability, while contributing to the decarbonisation of the EU economy. It will set the framework conditions to enable bioeconomy startups, entrepreneurs and new business models to thrive.
21 March 2025 - DRAFT REPORT on the future of the EU biotechnology and biomanufacturing sector (from the European Parliament, Committee on Industry, Research and Energy).
Criteria for a comprehensive EU Biotech Act.
1. Underlines Parliament’s commitment to the ‘one in, one out’ and simplification principles; asks that the EU biotech act be accompanied by an impact and cost assessment, as well as a comprehensive assessment by the Regulatory Scrutiny Board;
2. Recommends streamlining and harmonising upcoming and current initiatives relating to biotechnology and biomanufacturing, such as the review of the EU’s bioeconomy strategy and the forthcoming life sciences strategy, with the objective of strengthening the industry through a clear industrial and research and development (R&D) competence; calls for the creation of a single coordination body, such as a ‘Chief Biotechnology Officer’, in the Commission;
3. Calls on the Commission to present a report on the implementation of current legislation in the field of biotechnology and biomanufacturing, including identifying potential gaps and regulatory barriers hampering the growth of the industry; urges the Commission to share with Parliament the preliminary findings of its study on regulatory burden and the potential need to change legislation related to biotechnology and biomanufacturing; calls for a biotechnology omnibus that simplifies current requirements for the sector across regulatory frameworks;
4. Calls on the Commission to streamline and simplify authorisation procedures for biotechnology materials and manufacturing, while maintaining a risk proportionate and science based approach, in particular in the context of the upcoming review of EU agencies such as the European Food Safety Authority and the European Chemicals Agency;
5. Recalls that harmonised and internationally competitive intellectual property protection rules for biotechnology and biomanufacturing patents are essential for the development of the industry; calls for a common clinical trials framework that allows for the use of real world evidence for biotechnology therapies; asks the Commission to present the current situation in this regard, as well as potential improvements;
6. Recommends using the next generation of regulatory sandboxes to assess the specific impact and possibilities of emerging biotechnology and biomanufacturing applications, ensuring that new technologies can be trialled in a controlled but flexible regulatory environment.
29 January 2025, COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE EUROPEAN COUNCIL, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS - A Competitiveness Compass for the EU.
"Life sciences are driving innovation in biotechnology, and hold great potential for competitiveness across sectors, from pharma to agriculture to energy to food and feed. The EU Bioeconomy Strategy will position the EU in the rapidly expanding bioeconomy market with a significant growth potential in bio based materials, biomanufacturing, biochemicals, and agri biotech sectors, reduce our reliance on fossil fuels and improve the economic perspectives of our rural areas. A new European Biotech Act will provide a forward looking framework conducive to innovation in areas like health technology assessment and clinical trials and more generally to leverage the potential that biotechnologies can bring to our economy."
We also read:
Flagship Actions Pillar 1: European Biotech Act and Bioeconomy Strategy [2025-2026].
EU Biotech Act - How did it start?
18 July 2024 - According to Ursula von der Leyen (in the Political Guidelines for the next European Commission 2024−2029):
"I want Europe to make the most of the biotech revolution. Biotechnologies, supported by AI and digital tools, can help modernise entire parts of our economy, from farming and forestry, to energy and health. In order to make it easier to bring biotech from the laboratory to factory and then onto the market we will propose a new European Biotech Act in 2025."
In the same document, in the part "A Preparedness Union," Ursula von der Leyen said:
"Beyond building up our capabilities, Europe also needs new ambition on crisis and security preparedness. We will work on a Preparedness Union Strategy, inspired by the report on EU civil and military preparedness to be presented by former Finnish President Sauli Niinistö later this year. As part of this, we will focus on further strengthening our cyber defence capabilities, coordinating national cyber efforts and securing our critical infrastructures – notably by developing a trusted European cyber defence industry.
Europe also needs a common approach to preventing and preparing other new threats, in particular those linked to chemical, biological, radiological and nuclear (CBRN) security. Building on the work of the Health Emergency Preparedness and Response Authority, we will present a new strategy to support medical countermeasures against public health threats, such as those linked to CBRN security, including joint procurement and stockpiling.
We must also work on integrated deterrence. With this in mind, we will strengthen our strategic approach to sanctions to ensure that we can react flexibly to new threats. This will look at how our sanctions framework against cyberattacks can be expanded and how a new sanctions regime against hybrid attacks on the EU and its Member States could work. "
20 March 2024, COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS - Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU.
Biotechnology and its application to manufacturing bio-based products, can be part of the solution to address many societal and environmental challenges, such as climate mitigation and adaptation, access to and sustainable use of natural resources, restoration of vital nature systems, food supply and security, and human health.
Biotechnology and biomanufacturing are key for the competitiveness and the modernisation of our economy due to their high growth potential and increased labour productivity. They also strongly enhance the EU’s open strategic autonomy and resilience by reducing industry’s dependency on fossil based input and other sources of raw materials, and increasing circularity. They help advance the European Health Union and achieve the European Green Deal objectives.
Biotechnology has also been identified as a critical technology from the economic security perspective, given its cross cutting nature. It is also one of the technologies prioritised in the Strategic Technologies for Europe Platform (STEP) regulation.
Biotechnology and biomanufacturing are important enablers for the bioeconomy at large, which cover all sectors and systems that rely on biological resources, their functions and principles (ecosystems, animals, plants, microorganisms and derived biomass, wood, including organic waste). At the same time, biotechnology and biomanufacturing depend on the wider bioeconomy for their inputs, and to some extent as an outlet for their products. They also have strong links with healthcare and especially the pharmaceutical industry.
The EU has an innovative and competitive biotech industry, whilst AI is set to accelerate many biotech innovations and developments. At the same time, the potential of biotechnology and biomanufacturing has also been recognised by other countries. Moreover, the EU has a strong domestic supply of renewable raw materials, such as wood. Today, the EU is well endowed with human talent, research and innovation results and capacities to further develop bio based manufacturing and biotechnologies.
However, to promote EU industrial competitiveness and its sustainability, greater efforts are needed to create the right environment for this sector to grow. European biotech and biomanufacturing companies need a supportive regulatory framework and more financing opportunities to thrive in Europe.
The Commission will assess how EU legislation and its implementation could be further streamlined to reduce any fragmentation, explore potential simplification, and shorten the time for biotech innovations to reach the market; as well as regulatory obstacles that arise at national or other governance levels which impede an effective single market. To this end, the Commission will launch a study that will map key current industrial bio based value chains, analyse the regulatory framework and the impact of relevant legislation, and thereby lay the foundations for a possible EU Biotech Act.
The Commission will continue to follow up and strengthen the EU level framework along with the main actions:
Action 1: Simplified regulatory framework and faster access to market: to prepare for this the Commission will launch a study analysing how the legislation that applies to biotech and biomanufacturing could be further streamlined across EU policies, exploring targeted simplifications to the regulatory framework, including for faster approval and bringing to the market. The study will be finalised by mid 2025 and could lay the foundations for a possible EU Biotech Act.
About the EU Dual-Use Regulation (Regulation (EU) 2021/821)
The Dual-Use Regulation governs the export, brokering, transit, and transfer of dual use items. like goods, software, and technology, that can be used for both civilian and military applications, and includes not only traditional technologies but also emerging technologies such as cybersecurity tools, quantum computing, artificial intelligence, and biotechnology.
The EU Dual-Use Regulation covers the provisions of the United Nations Security Council Resolution 1540 (2004). All States must take and enforce effective measures to establish domestic controls to prevent the proliferation of nuclear, chemical or biological weapons and their means of delivery, including by establishing appropriate controls over related materials, equipment and technology.
The Regulation also covers controls required under international agreements, such as the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and On Their Destruction (the ‘Biological and Toxin Weapons Convention’ or ‘BWC’).
According to Article 1, the Regulation establishes a Union regime for the control of exports, brokering, technical assistance, transit and transfer of dual use items.
According to Article 2, ‘dual use items’ means items, including software and technology, which can be used for both civil and military purposes, and includes items which can be used for the design, development, production or use of nuclear, chemical or biological weapons or their means of delivery, including all items which can be used for both non explosive uses and assisting in any way in the manufacture of nuclear weapons or other nuclear explosive devices.
According to Article 3, authorisation is required for the export of certain dual use items (listed in Annex I of the Dual Use Regulation).
The Dual Use Regulation must be understood within the broader EU strategy for technological sovereignty, supply chain resilience, and security policy. As global tensions rise, the Regulation allows the EU to restrict sensitive technology flows to strategic competitors or jurisdictions of concern, both to prevent misuse and to protect critical EU capabilities.
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