Will the EU Become the Most Attractive Place for Life Sciences? How the EU Woos Biotech

The European Commission made a lofty commitment in its recently published Life Sciences Strategy to position the EU as the world’s most attractive place for life sciences by 2030. To succeed with this vision, EU lawmakers must ensure that these efforts will truly cut red tape and accelerate innovation rather than simply adding new layers of regulation. They must also ensure that these efforts are not undermined by other legislative changes affecting the EU’s biotech industry.

Europe’s biotech landscape is being reshaped by a complex web of initiatives, from sweeping strategic plans to targeted new laws. Recent weeks have seen the European Commission (Commission) unveil a Life Sciences Strategy, which provides a broad vision to bolster innovation across health, agriculture, industry, and environmental biotech, alongside the proposal for a Critical Medicines Act (see Sidley Blog), a policy work on a prospective Biotech Act, and an ongoing overhaul of the EU’s General Pharmaceutical Legislation (GPL).

Together with Mario Draghi’s report outlining a Competitiveness Strategy for Europe from September 2024 as well as the Commission’s Competitiveness Compass from January 2025, the Life Sciences Strategy and the forthcoming Biotech Act signal a clear recognition that biotechnology is a critical enabler of the EU’s economic competitiveness, health resilience, and sustainability. While the Life Sciences Strategy outlines a high-level vision, the Biotech Act promises concrete regulatory reform.

This article explores how these initiatives interact and what they might mean for biotech developers navigating the EU’s evolving regulatory landscape.

Life Sciences Strategy — Lofty but Promising

On July 1, 2025, the Commission published its Strategy for Life Sciences: “Choose Europe for life sciences — A strategy to position the EU as the world’s most attractive place for life sciences by 2030.” The strategy is not a binding legal instrument, but it sets out the Commission’s vision for strengthening the EU’s life sciences ecosystem across various sectors spanning health, food, agriculture, industrial biotech, and the environment. The strategy proposes action in three interconnected phases:

1. Optimizing the research and innovation ecosystem by strengthening EU-wide coordination and infrastructure, with a strong focus on data, artificial intelligence (AI), and sustainability, notably through the development of an EU investment plan to facilitate funding for multi-country clinical trials.
2. Enable rapid market access for life science innovations by promoting innovation-friendly regulation and investment mobilization to reduce time to market for biotechnological innovation.
3. Boost trust, uptake, and use of innovation by simplifying EU public procurement rules, a forthcoming European Innovation Act, and investing in end-user engagement.

For now, the Life Sciences Strategy provides a high-level roadmap. The next step will be turning these aspirations into concrete actions. In this context, a centerpiece initiative on the horizon is the proposed European Biotech Act, which aims to tackle some of the persistent barriers holding back European biotech, including development of new biological medicinal products.

A Biotech Act — Success or More Red Tape?

The idea of a Biotech Act was initially raised in the Commission’s “Boosting Biotechnology and Biomanufacturing in the EU” in March 2024 and again in President Ursula von der Leyen’s political guidelines in July 2024. The anticipated publication timing is 2026.

Although the content details remain vague, today, all eyes are on the Biotech Act as a potential game-changer for the industry.

• Scope Will Be Critical: A key debate is whether the Biotech Act will be narrowly focused on healthcare or take a more comprehensive cross-sector approach. While the Health Directorate (DG SANTE) has the lead on the file, the Commissioners for Startups, Research, and Innovation (DG RTD) and Prosperity and Industrial Strategy (DG GROW) play contributing roles, suggesting a broader scope that encompasses not only healthcare but also agri-food, industrial, and environmental biotechnology.

The Commission’s Life Sciences Strategy and the Biotech Act’s call for evidence indicate that the Biotech Act aims to the existing patchwork of biotech-related rules. Its horizontal approach and emphasis on harmonization imply that the Act will likely take the shape of a regulation (directly applicable) and could, in addition to containing self-standing rules, amend, simplify, and align multiple legislative frameworks such as the Clinical Trials Regulation, the Advanced Therapy Medicinal Products framework, genetically modified organism (GMO) regulations, and funding instruments to create a more unified biotech policy across the EU.

The Commission itself has emphasized that the Biotech Act should “reduce any fragmentation, explore potential simplification, and shorten the time to market for biotech innovations” while addressing regulatory obstacles at national levels.

In other words, the Biotech Act is widely seen as a critical opportunity to restore the EU’s competitiveness in life sciences through a streamlined, standardized environment that accelerates biotech development — rather than adding new hoops to jump through.

• Responses From Industry: In the meantime, various industry stakeholders have made their priorities clear through the call for evidence launched by the Commission (which closed on June 11, 2025).

Based on these responses, several key opportunities and concerns have emerged:

• Strengthening of Intellectual Property (IP) is Vital: The industry deems robust and internationally competitive patent and regulatory rules (e.g., patent term extensions and effective enforcement) necessary to encourage research-and-development investment. The Biotech Act is seen as an opportunity to bolster IP incentives that spur innovation. However, whether the Biotech Act can deliver on these promises will chiefly depend on the outcome of the broader review of the GPL as the effects of new biotech incentives could be washed away if rules reducing innovators’ patent rights or regulatory are adopted.
• Facilitating Clinical Research: The EU has launched several initiatives in recent years to facilitate clinical research in the EU such as Accelerating Clinical Trials in the EU, or ACT EU. However, clinical trial sponsors are concerned that the EU’s current landscape remains overly slow and administratively burdensome. Often-raised criticism include the (in practice) lack of streamlined clinical trial application reviews at Member State level as well as fragmented ethics committee rules. Rules for multi-country trials (common in rare-disease settings) face additional hurdles such as parallel national ethics approvals. Fast access to diagnostic tools and assays for use in clinical trials are equally a challenge for sponsors who battle the onerous requirements of the In Vitro Diagnostics Regulation, most of which are for use in a rare disease setting.

However, as industry comments show, there is a major opportunity for the Biotech Act to build on the foundations of existing legislation and initiatives to facilitate more efficient rules for clinical trials in the EU.

• Regulatory Harmonization: Today, overlapping or inconsistent rules across a patchwork of regulations covering the development of biologics (medicinal products, medical devices/diagnostics, GMOs) create complexity and delays for bringing new treatments to the market. For example, gene therapies face additional time and resource challenges in complying with the GMO framework.

The Biotech Act presents an opportunity to align and modernize these regulatory pathways by harmonizing and streamlining duplicative pathways or aligning rules across domains.

• Boosting Investment and Manufacturing Capacity: EU biotech innovators often face challenges to secure funding and to scale up innovations. In addition, high costs and fragmented support can drive manufacturing overseas. The Biotech Act presents an opportunity to address these challenges through measures that channel more risk-tolerant capital into EU biotech startups and scale-ups, helping them grow. Notably, in early 2025, the Commission launched an EU Biotech Hub as a one-stop operational support tool for biotech innovators. Moreover, the Life Sciences Strategy calls for an EU investment vehicle to support multi-country trials and hints at dedicating additional to life sciences innovation.

Supportive measures in the Biotech Act could encourage building production capacity for biologics and other biotech products within the EU. Such action would complement the proposed Critical Medicines Act, which already seeks to improve the availability, supply, and production of critical medicines in the EU.

• Embracing Digital Tools and AI: The transformative potential of digital tools in life sciences is enormous, but stakeholders point out that clearer guidance and regulatory frameworks are needed to fully harness these technologies. The need for clarity and regulatory convergence includes issues such as the use of (and compliance with data protection rules), acceptance of real-world evidence, and the validation of AI algorithms in healthcare.

The Biotech Act could be a starting point for the EU to set a balanced framework that encourages the integration of digital tools and AI throughout the product lifecycle, although it is likely that this will be concretized through implementing measures and regulatory guidance.

Other Initiatives

The drive for biotech innovation in the EU is multifaceted, and the Biotech Act will not exist in isolation. A number of related initiatives and policy moves are underway alongside it, for example:

• As mentioned above, in early 2025, the Commission launched an EU Biotech Hub to help companies, especially startups and small and medium-size enterprises, navigate the regulatory framework and bring products to market. It provides resources on everything from sources of EU funding and research infrastructure to advice on intellectual property and regulatory requirements, with the aim of easing scale-up and reducing fragmentation for biotech developers.
• The European Parliament recently ing the Commission to ensure that the proposal for a Biotech Act be justified by clear gaps in current law and that it reduces (not adds) administrative burdens for the industry. It also calls on the Commission to present a report, including preliminary findings, on such gaps analysis. A from May, predating the resolution, summarises the current state-of-play, including key stakeholders’ views on the Biotech Act.
• Members of the European Parliament have launched an EU Biotech and Life Sciences Alliance aimed at reinforcing the EU’s global leadership in biotechnology.

What Is Next?

The success of the Biotech Act will ultimately depend on its ability to reduce regulatory fragmentation and delays while complementing (not duplicating) other initiatives. For Europe’s biotech companies and investors, the hope is that this Act can truly cut through the red tape by creating a unified framework that makes the EU an attractive place to invent, test, and commercialize the next generation of biotech innovations.

The Commission is expected to publish its proposal for the Biotech Act in 2026. Following such publication, the European Parliament and the Council will have the opportunity to propose amendments, with likely to take place before the Act’s adoption.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.