The Biotech Act: A quiet but profound policy shift

From protection to competitiveness

The European Commission’s Biotech Act proposal, published in December 2025, is both timely and welcome.

Perhaps the most striking feature of the proposal lies not in its articles, but in its recitals.

The Commission justifies the Biotech Act primarily through the lens of EU competitiveness and the funding needs of European scale-up companies. This is noteworthy. Traditionally, EU health legislation has been driven by precaution, patient protection, and harm avoidance. Industry interests have often been accommodated but rarely placed so explicitly at the centre of the policy rationale.

And the arguments are solid. EU’s strong science base does not shy from US and China, but in venture cap investments EU is half of China and one tenth of US. Over the last six years, 66 out of 67 EU biotechnology companies that went public chose a non-EU stock exchange. How often have we read these kinds of figures from the European Commission on legal proposals as justification for legislation?

In this sense, the Biotech Act represents a clear policy shift. Health policy is no longer only about safeguarding citizens from risk; it is also about safeguarding Europe’s position in global innovation and investment landscapes. That this argument is made so openly—and repeatedly—marks a new level of urgency in the EU thinking about biotechnology.

A surprising and welcome link to the European Health Data Space

Equally interesting is how the proposal links biotechnology policy to the European Health Data Space (EHDS). While the EHDS establishes an ambitious framework for the secondary use of health data, it remains relatively cautious in imposing binding data quality obligations. Such obligations were proposed in the TEHDAS Joint Action data quality report (2021–2023), coordinated by the Finnish Innovation Fund Sitra, but they were not ultimately included in binding form in the final regulation. The Biotech Act partially fills this gap by introducing concrete data quality measures for biotechnology strategic projects.

If implemented well, this could be transformative. Harmonised, high-quality datasets would not only benefit incumbent actors but would significantly lower entry barriers for new research and innovation—particularly projects built on standardised data models such as OMOP. Instead of each new project starting from scratch with costly data curation, future initiatives could build on progressively improved datasets.

For this reason, it is crucial that the European Parliament and Council preserve these data quality provisions during the legislative negotiations. Diluting them would mean losing one of the most forward-looking elements of the proposal.

Priority status and fast-track ambiguity

That said, the proposal would benefit from greater legal clarity. Article 12(4) states that permit-granting processes for biotechnology strategic projects shall be treated “in the most rapid way possible” and benefit from any accelerated procedures available under Union and national law. In parallel, EHDS Article 68(6) introduces accelerated procedures for data permits.

The obvious question is whether these two provisions intersect. Does the Biotech Act imply that biotechnology strategic projects should automatically benefit from accelerated EHDS data permit procedures? Given how central access to data is for biotechnology innovation, this ambiguity deserves clarification.

Funding gaps cannot be legislated away

At the same time, expectations should remain realistic. No EU regulation—however well drafted—can on its own bridge the funding gap between the EU and the United States. This gap has developed over decades and extends far beyond the health sector. The structural weakness of venture capital in Europe is tied to broader questions about financial markets, risk appetite, and how companies are built and scaled.

Regulation can reduce friction and create incentives, but it cannot substitute for capital.

Ambition, culture, and the politics of success

Finally, funding is not only about money; it is also about ambition. In the EU, international growth often means selling products across borders within the single market. In the US, “going international” typically means expanding beyond North America—into Europe, Asia, or South America.

This difference reflects more than the market size. It reflects cultural attitudes toward success. Do we celebrate successful companies and their leaders, or do we view them with suspicion? Do we see private profits as a source of prosperity for Europe, or primarily as a signal of inequality?

The Biotech Act implicitly acknowledges that competitiveness is not just a technical problem, but a political and cultural one. In that sense, its greatest contribution may be the debate it opens rather than the articles it contains.