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!