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 bio-manufacturing, 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.
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 increase 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, micro-organisms 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 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—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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