Building a competitive and sustainable biotech ecosystem in Europe

Does Europe still have a realistic chance of remaining competitive with the United States and China in biotechnology—and under what political conditions?

 Europe is not short of scientific prowess nor of intellectual openness. Yet these assets are blunted by structural shortcomings. The absence of a truly integrated Single Market—most notably an incomplete Capital Markets Union—limits access to the scale of financing routinely available in the United States and, increasingly, China.

Regulatory fragmentation compounds the problem: divergent national rules and slower approval timelines impose costs, delay innovation and deter investment.

In health biotech, the need to navigate up to 27 distinct pricing and reimbursement regimes further slows patient access and undermines Europe’s appeal as a launch market. Without tackling these systemic frictions, Europe’s competitive position will continue to erode.

 Will the upcoming Biotech Act be a true industrial turning point, or just another regulatory adjustment?

 It could yet mark a turning point. The promise lies in streamlining clinical trials and accelerating development pathways—areas where Europe has lagged. Faster, more predictable processes would enhance the continent’s attractiveness as a research hub.

Investment incentives, including instruments such as supplementary protection certificates, could also help anchor R&D and manufacturing within the EU.

Much, however, hinges on execution: the ambition, coherence and financial depth of the final framework—particularly regarding strategic projects and access to capital—will determine whether the Act reshapes the landscape or simply tidies its edges.

 Why does Europe continue to lose its biotech companies at the scale-up stage, and what must the EU change immediately?

The fault lies chiefly in financing. European firms with global ambitions often look across the Atlantic—frequently to Nasdaq—to access deeper pools of specialised capital. This reflects a broader incapacity to mobilise risk capital at scale within Europe itself. Advancing the Savings and Investment Union is therefore not a technocratic aspiration but an economic necessity. Without it, Europe will remain a nursery for innovation rather than a home for global biotech leaders.

 Is health sovereignty compatible with a globally open and competitive biotech industry?

Yes—provided it is interpreted pragmatically. Sovereignty need not imply protectionism. Rather, it should denote the capacity to reinforce domestic capabilities while remaining embedded in global networks of research, supply and distribution. A resilient biotech ecosystem depends as much on international integration as on local strength.

 Should Europe be willing to take greater regulatory risks to accelerate innovation?

Not in the sense of lowering standards.

Europe’s regulatory credibility rests on its commitment to safety and environmental protection.

The lesson of the pandemic, however, is that speed and rigour are not mutually exclusive. More agile, risk-based processes can shorten timelines without diluting safeguards. The task is to eliminate procedural inertia, not to weaken oversight—a principle the Biotech Act could usefully enshrine.

 Is Europe too cautious—perhaps even too distrustful—of biotechnology to remain a global leader?

The issue is less cultural distrust than institutional complexity. Decision-making in the EU requires alignment across 27 member states, alongside democratic scrutiny and stakeholder consultation. This inevitably slows progress compared with more centralised systems. The challenge is not to abandon this model, but to render it more nimble: better coordination, quicker decision-making and a firmer grip on collective priorities. Without this, national sensitivities and political caution will continue to dilute and delay Europe’s ambitions in biotechnology.