Biotechnology is central to modern medicine and Europe’s long-term competitiveness. From cancer and cardiovascular disease to rare conditions, it is driving transformative advances for patients across Europe and beyond.1
Yet innovation in Europe is increasingly shaped by regulatory fragmentation, procedural complexity and uneven implementation across member states. As scientific progress accelerates, policy frameworks must evolve in parallel, supporting the full lifecycle of innovation from research and clinical development to manufacturing and patient access.
The proposed EU Biotech Act seeks to address these challenges. By streamlining regulatory procedures, strengthening coordination and supporting scale-up and manufacturing, it aims to reinforce Europe’s position in a highly competitive global biotechnology landscape.2
Its success, however, will depend less on ambition than on delivery. Consistent implementation, proportionate oversight and continued global openness will determine whether the act translates into faster patient access, sustained investment and long-term resilience.
Q: Why is biotechnology increasingly seen as a strategic pillar for Europe’s competitiveness, resilience and long-term growth?
Gilles Marrache, SVP and regional general manager, Europe, Latin America, Middle East, Africa and Canada, Amgen: Biotechnology sits at the intersection of health, industrial policy and economic competitiveness. The sector is one of Europe’s strongest strategic assets and a leading contributor to research and development growth.3
At the same time, Europe’s position is under increasing pressure. Over the past two decades, the EU has lost approximately 25 percent of its global share of pharmaceutical investment to other regions, such as the United States and China.
The choices made today will shape Europe’s long-term strength in the sector, influencing not only competitiveness and growth, but also how quickly patients can benefit from new treatments.
Europe stands at a pivotal moment in biotechnology. Our life sciences legacy is strong, but maintaining global competitiveness requires evolution.”4
Gilles Marrache, SVP and regional general manager, Europe, Latin America, Middle East, Africa and Canada, Amgen.
Q: What does the EU Biotech Act aim to do and why is it considered an important step forward for patients and Europe’s innovation ecosystem?
Marrache: The EU Biotech Act represents a timely opportunity to better support biotechnology products from the laboratory to the market.
By streamlining medicines’ pathways and improving conditions for scale-up and investment, it can help strengthen Europe’s innovation ecosystem and accelerate patient access to breakthrough therapies. These measures will help anchor biotechnology as a strategic priority for Europe’s future — and one that can deliver earlier patient benefit — so long as we can make it work in practice.
Q: How does the EU Biotech Act address regulatory fragmentation, and where will effective delivery and coordination be most decisive?
Marrache: Regulatory fragmentation has long challenged biotechnology development in Europe, particularly for multinational clinical trials and innovative products. The Biotech Act introduces faster, more coordinated trials, expanded regulatory sandboxes and new investment and industrial capacity instruments.
The proposed EU Health Biotechnology Support Network and a union-level regulatory status repository would strengthen transparency and predictability. Together, these measures would support earlier regulatory dialogue, help de-risk development and promote more consistent implementation across member states.
They also create an opportunity to address complexities surrounding combination products — spanning medicines, devices and diagnostics — where overlapping requirements and parallel assessments have added delays.5 This builds on related efforts, such as the COMBINE programme,6 which seeks to streamline the navigation of the In Vitro Diagnostic Regulation,7 Clinical Trials Regulation8 and the Medical Device Regulation9 through a single, coordinated assessment process.
Continued clarity and coordination will be essential to reduce duplication and accelerate development timelines.10
Q: What conditions will be most critical to support biotech scale-up, manufacturing and long-term investment in Europe?
Marrache: Europe must strike the right balance between strategic autonomy and openness to global collaboration. Any new instruments under the Biotech Act mechanisms should remain open and supportive of all types of biotech investments, recognizing that biotech manufacturing operates through globally integrated and highly specialized value chains.
Q: How can Europe ensure faster and more predictable pathways from scientific discovery to patient access, while maintaining high standards of safety and quality?
Marrache: Faster and more predictable patient access depends on strengthening end-to-end pathways across the lifecycle. The Biotech Act will help ensure continuity of scientific and regulatory expertize, from clinical development through post-authorization. It will also support stronger alignment with downstream processes, such as health technology assessments, which are critical to success.
Moreover, reducing unnecessary delays or duplication in approval processes can set clearer expectations, more predictable development timelines and earlier planning for scale-up.
Finally, embedding a limited number of practical tools (procedural, digital or governance-based) and ensuring they are integrated within existing European Medicines Agency and EU regulatory structures can help achieve faster patient access.11
Q: What role can stronger regulatory coordination, data use and public-private collaboration play in strengthening Europe’s global position in biotechnology?
Marrache: To unlock biotechnology’s full potential, consistent implementation is essential. Fragmented approaches to secondary data use, divergent member state interpretations and uncertainty for data holders still limit access to high-quality datasets at scale. The Biotech Act introduces key building blocks to address this.
These include Biotechnology Data Quality Accelerators to improve interoperability, trusted testing environments for advanced innovation, and alignment with the EU AI Act,12 European Health Data Space13 and wider EU data initiatives. It also foresees AI-specific provisions and clinical trial guidance to provide greater operational clarity.
Crucially, these structures must simplify rather than add further layers of complexity.
Addressing remaining barriers will reduce legal uncertainty for AI deployment, support innovation and strengthen Europe’s competitiveness.
These reforms will create a modernized biotech ecosystem, healthier societies, sustainable healthcare systems and faster patient access to the latest breakthroughs in Europe.”14
Gilles Marrache, SVP and regional general manager, Europe, Latin America, Middle East, Africa and Canada, Amgen.
Q: As technologies evolve and global competition intensifies, how can policymakers ensure the Biotech Act remains flexible and future-proof?
Marrache: To remain future-proof, the Biotech Act must be designed to evolve alongside scientific progress, market dynamics and patient needs. Clear objectives, risk-based requirements, regular review mechanisms and timely updates to guidance will enhance regulatory agility without creating unnecessary rigidity or administrative burden.
Continuous stakeholder dialogue combined with horizon scanning will be essential to sustaining innovation, resilience and timely patient access over the long term. Preserving regulatory openness and international cooperation will be critical in avoiding fragmentation and maintaining Europe’s credibility as a global biotech hub.
Q: Looking ahead, what two or three priorities should policymakers focus on to ensure the EU Biotech Act delivers meaningful impact in practice?
Marrache: Looking ahead, policymakers should focus on three priorities for the Biotech Act:
First, implementation must deliver real regulatory efficiency, predictability and coordination in practice.
Second, Europe must sustain an open and investment-friendly framework that reflects the global nature of biotechnology.
And third, policymakers should ensure a clear and coherent legal framework across the lifecycle of innovative medicines, providing certainty for the use of artificial intelligence — as a key driver of innovation in health biotechnology.
In practical terms, the EU Biotech Act will be judged not by the number of new instruments it creates, but by whether it reduces complexity, increases predictability and shortens the path from scientific discovery to patient benefit.
An open, innovation-friendly framework that is competitive at the global level will help sustain investment, strengthen resilient supply chains and deliver better outcomes for patients across Europe and beyond.
References
- Amgen Europe, The EU Biotech Act Unlocking Europe’s Potential, May 2025. Retrieved from https://www.amgen.eu/media/press-releases/2025/05/The_EU_Biotech_Act_Unlocking_Europes_Potential
- European Commission, Proposal for a Regulation to establish measures to strengthen the Union’s biotechnology and biomanufacturing sectors, December 2025. Retrieved from https://health.ec.europa.eu/publications/proposal-regulation-establish-measures-strengthen-unions-biotechnology-and-biomanufacturing-sectors_en
- EFPIA, The pharmaceutical sector: A catalyst to foster Europe’s competitiveness, February 2026. Retrieved from https://www.efpia.eu/media/zkhfr3kp/10-actions-for-competitiveness-growth-and-security.pdf
- The Parliament, Investing in healthy societies by boosting biotech competitiveness, November 2024. Retrieved from https://www.theparliamentmagazine.eu/partner/article/investing-in-healthy-societies-by-boosting-biotech-competitiveness#_ftn4
- Amgen Europe, The EU Biotech Act Unlocking Europe’s Potential, May 2025. Retrieved from https://www.amgen.eu/docs/BiotechPP_final_digital_version_May_2025.pdf
- European Commission, combine programme, June 2023. Retrieved from https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme_en
- European Commission. Medical Devices – In Vitro Diagnostics, March 2026. Retrieved from https://health.ec.europa.eu/medical-devices-vitro-diagnostics_en
- European Commission, Clinical trials – Regulation EU No 536/2014, January 2022. Retrieved from https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-regulation-eu-no-5362014_en
- European Commission, Simpler and more effective rules for medical devices – Commission proposal for a targeted revision of the medical devices regulations, December 2025. Retrieved from https://health.ec.europa.eu/medical-devices-sector/new-regulations_en#mdr
- Amgen Europe, The EU Biotech Act Unlocking Europe’s Potential, May 2025. Retrieved from https://www.amgen.eu/docs/BiotechPP_final_digital_version_May_2025.pdf
- AmCham, EU position on the Commission Proposal for an EU Biotech Act
- European Commission, AI Act | Shaping Europe’s digital future, June 2024. Retrieved from https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai
- European Commission, European Health Data Space, March 2025. Retrieved from https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en
- The Parliament, Why Europe needs a Biotech Act, October 2025. Retrieved from https://www.theparliamentmagazine.eu/partner/article/why-europe-needs-a-biotech-act
Disclaimer
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- The sponsor is Amgen Inc
- The ultimate controlling entity is Amgen Inc
- The political advertisement is linked to advocacy on the EU Biotech Act.
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