Why Europe Needs a Biotech Act

By Nicholas Cosenza, Head of EU Government Affairs, Amgen

Biotechnology harnesses biological systems—often using living cells and organisms—to develop innovative therapies, tools, and technologies that address some of the most complex health challenges. In the biopharmaceutical space, this has led to the development of biologic medicines: highly sophisticated treatments for cancer, cardiovascular diseases, autoimmune conditions, rare disorders, and other serious diseases.

Although these therapies represent some of the most advanced innovations in modern medicine, they are complex—in both structure and manufacturing. Even the slightest changes in the production process can impact their safety, efficacy or quality. These complexities require equally advanced and flexible regulatory frameworks that are responsive, coherent, and future-oriented.

Regulatory hurdles in the EU

The EU stands at a pivotal juncture for this field. Despite a rich legacy in life sciences research and a strong ecosystem of scientists and innovators, our biotechnology sector is increasingly constrained by a fragmented and complex environment. Regulatory inefficiencies, limited access to capital, and inconsistent policy support risk slowing progress—and driving innovation to more supportive markets abroad. The European Commission has seen the potential of this sector as illustrated through the Draghi report and by announcing a planned Biotech Act. There is hope that the EU can take the right turn at this juncture to support continued innovation and expansion in this sector.

At Amgen, we understand both the extraordinary promise and the practical challenges of biotechnology. For over four decades, we’ve been at the forefront of biotech innovation, developing biologic therapies that have improved and extended the lives of millions of patients worldwide. As a company founded as a start-up in the 1980s that rapidly grew to a multinational pharmaceutical company with operations in more than 100 countries, Amgen can bring valuable experience to the table. That journey has also shown us where the system can—and must—do better.

The Biotech Act

The proposed European Biotech Act offers a crucial opportunity to address longstanding structural barriers and reestablish the EU as a world-class destination for biotech investment and innovation. Key issues that need to be tackled include:

· Fragmented clinical trial processes across Member States that hinder multi-country research and delay patient access to innovative therapies.

· Complex and overlapping regulatory frameworks, especially for combination products involving diagnostics or devices.

· Insufficient regulatory resources and biotech-specific expertise within review bodies, slowing the evaluation and approval of cutting-edge biologics.

· Duplicative quality control requirements, such as import testing, that reduce supply chain flexibility and create unnecessary delays.

· Limited access to risk capital, particularly for small and mid-sized biotech companies driving innovation in areas like orphan and advanced therapies.

· Weak harmonisation of health data and artificial intelligence frameworks, which hampers the uptake of modern tools in clinical development.

· Barriers to adoption in healthcare systems, where fragmented national policies often fail to recognise the value and urgency of biotech innovation.

Regional and national coordination

We cannot stop at the regional level – we need to ensure countries across the Union are not only on board with ambitious changes, but also willing to do their part to translate the EU’s biotech vision into reforms that are specific to their healthcare systems’ needs.

National strategies are already being developed and positioned as implementation engines. For instance, Denmark’s Life Sciences Strategy similarly includes dedicated regulatory pilots, improved coordination across agencies, and support for early-stage biotech innovation. Similarly, the Dutch Cabinet Vision on Biotechnology 2025-2040, recently published, outlines concrete steps to modernise regulatory frameworks, promote responsible biotech development, and foster public engagement, creating a nationally aligned ecosystem ready to absorb EU-level reforms. By embedding flexibility, regulatory agility, and innovation-readiness into national structures, Member States can both accelerate the uptake of EU legislation and provide valuable evidence to inform its design.

Seizing the opportunity

Amgen and EUCOPE welcome the European Commission’s renewed focus on biotechnology. The Biotech Act must seize this momentum to prioritize faster patient access to innovation and establish a foundation for Europe’s leadership in the next generation of medical breakthroughs.