Brussels will soon head into the summer break, but the debate on Europe’s biotech future is far from slowing down. Across Europe, policymakers are increasingly recognizing biotech as a strategic priority for competitiveness, resilience and economic growth. As Europe faces growing competition from the US and China for biotech investment, talent and manufacturing, it is important that we answer a critical question: how does Europe remain a place where biotech companies can start, scale and succeed? With the European Commission‘s impact assessment on the Biotech Act published and the Council of the European Union and European Parliament beginning to reveal their positions, the discussion is moving in real time. And while Europe makes up its mind, there is still an opportunity for the sector to influence the outcome. Hollandbio is tuning in. You too?

Encouragingly, momentum is growing behind priorities long championed by hollandbio and our European partners. The Commission’s own impact assessment confirms what many in our sector have been saying for years: Europe excels at science, but struggles to translate that excellence into investment, scale-up and manufacturing. Better access to capital, regulatory streamlining, stronger scale-up, and a more coherent biotech ecosystem spanning health, food and materials are therefore all gaining political traction.

The Council recently responded positively to measures streamlining rules for certain genetically modified microorganisms (GMMs) and organ transplantation, while introducing only minor additional safeguards. Lead rapporteurs in Parliament have also largely backed the act and significantly taken up industry-supported amendments into the draft report, reportedly including proposals to extend regulatory sandboxes to novel foods. The Commission’s impact assessment likewise highlights regulatory sandboxes as a valuable tool for supporting innovative biotech companies, particularly SMEs. Together, these developments signal growing recognition that Europe’s innovation agenda should support the full breadth of biotech, from medicines to food and materials and from discovery all the way to deployment.

Not everything is settled, however. Significant political differences remain in how Europe should strengthen its biotech ecosystem. While some committees (SANT & ITRE) support stronger intellectual property incentives to attract and retain investment, others (ENVI & JURI) favor public-private partnerships, targeted funding and regulatory support measures.

And that debate matters. While the Commission concludes that the Act can contribute to a more competitive and innovative European biotech ecosystem, a recent Charles River Associates (CRA) analysis commissioned by EFPIA concludes that the current Biotech Act proposal alone is unlikely to close Europe’s competitiveness gap with the United States and China. According to CRA, Europe currently lacks a clear advantage on any of the main drivers of biotech investment, including access to capital, clinical research, manufacturing conditions and market access. So, for the biotech act ambitions to hold up their promise, even more is needed.

In the coming months, negotiations on Biotech Act I will continue, while publication of the much-anticipated Biotech Act II is also expected, aiming to address broader ecosystem challenges around investment, scale-up and industrial capacity. Together, these initiatives will need to show how Europe plans to strengthen its biotech ecosystem and translate scientific excellence into societal and economic impact. In the meantime, hollandbio will continue advocating for an ambitious framework that enables biotech companies to innovate, scale and create impact in Europe.

There is a feedback opportunity on the Biotech Act part I that remains open until 5 August to which hollandbio will be submitting a response on behalf of the sector. But policymakers also need to hear directly from the organisations developing tomorrow’s solutions, so we also encourage you to contribute your own perspective. And for those that would like to go one step further, join our LinkedIn campaign to share what Europe should act for, whether that’s new medicines, future-proof materials, food security or a healthier planet.

The more biotech professionals join, the more policymakers hear what biotech can deliver, and the harder it becomes to ignore what Europe stands to lose. This is the moment to speak up. Together, we can help ensure Europe’s bright biotech future!

The Call for Evidence on Biotech Act II is now open (deadline June 10th): a crucial opportunity for input the European biotech sector cannot afford to miss. With this next phase, the European Commission is focusing on industrial biotechnology and biomanufacturing, aiming to address bottlenecks such as insufficient market uptake, investment predictability and timelines, and fragmentation of the EU single market and regulation for bio-based products.
At hollandbio, we call for an ambitious and broad Biotech Act II that must work for all kinds of biotech products and biosolutions, as well as across the entire value chain, from early research to scale up and real world use. That requires an integrated approach to biotech policy, real investment in frontrunners, faster, predictable routes to market and market pull that helps innovations reach patients and consumers. This is the moment to act. So, make your voice heard before June 10th and help shape a Biotech Act II that lets biotech deliver, right here in Europe!

In December 2025, the European Commission unveiled Part I of the EU Biotech Act, a long-awaited signal that Europe aims to unlock biotech’s full potential. During the holidays, the Dutch government dove into the EU proposals to draft its assessment, a so-called BNC-fiche. And, as the Netherlands does not shy away from communicating its strong ambition when it comes to biotech, hollandbio had high hopes that the Dutch government would call for even bolder moves, including proper EU and national resourcing and a broader scope of the Act. The current act still risks falling short of being the breakthrough the EU needs in a highly competitive global landscape. But unfortunately, we felt the official assessment of the EU Biotech Act Part I to be somewhat disappointing.

As expected, the Dutch fiche does embrace biotech’s role in strengthening Europe’s competitiveness, along with attention to workability, harmonisation, and Dutch best practices. But at the same time, the overall stance is surprisingly cautious, in contrast to the previously published broad, forward‑leaning Dutch non‑paper and national biotech vision. Rather than seizing Europe’s opportunity to lead, the fiche places significant weight on feasibility, governance and constraints. Important points, certainly, but for a country that wants to lead in biotech by 2040, we expected stronger follow‑through from ambition to action.

That’s why hollandbio remains fully engaged, contributing to Parliamentary consultations, advising policymakers and feeding insights into both Part I and Part II of the act. Our overall goal, and corresponding asks, remains unchanged: an EU Biotech Act that works end-to-end for health, food and industrial biotech. Read our full analysis here.