Rewriting the Rulebook: EU Biotech Regulations Under Review

As Europe positions itself to expand its influence in the global biotechnology sector—where it currently holds a 12% market share—experts, policymakers, and industry leaders gathered to examine how biosecurity measures can coexist with innovation and competitiveness. The roundtable, held on April 9 and co-hosted by the Centre for Future Generations and Euractiv, highlighted the strategic significance of biotech for Europe’s economy and security.

While biosecurity is traditionally seen as a framework for minimizing biological risks, the discussion also framed it as a catalyst for innovation and market leadership. According to Euractiv, stakeholders emphasized that effective biosecurity policies can foster public trust and investor confidence in biotech products across sectors such as health, agriculture, and manufacturing.

A Dual Role for Biosecurity

Irene Sacristán Sánchez, who leads the Biotechnology Unit within DG SANTE at the European Commission, underscored the importance of balancing safety with progress. She explained that biosecurity not only shields public and environmental health but also enhances the resilience of supply chains. Per Euractiv, Sánchez believes that Europe’s robust biosafety framework contributes to its competitive edge by ensuring the safety of biotech innovations without stifling development.

Sánchez, who is also involved in shaping the upcoming Biotech Act and overseeing regulations for genetically modified organisms and New Genomic Techniques (NGTs), noted that safeguarding human and animal health remains a priority. However, she emphasized that biotech also plays a direct role in strengthening biosecurity—such as through pest-resistant crops—and can bolster Europe’s strategic autonomy.

Navigating the Safety-Competitiveness Spectrum

Tomislav Sokol, Member of the European Parliament and a key figure in the SANT Committee, addressed the challenge of reconciling strict safety regulations with the need for economic vitality. According to Euractiv, Sokol warned against compromising on safety standards but acknowledged that unnecessary bureaucracy could be trimmed to enhance efficiency.

He pointed to regulatory redundancies in medical device certification as an area ripe for reform. Streamlining processes like public procurement and permits, while maintaining high safety thresholds, could provide a much-needed boost to the EU’s biotech competitiveness.

Sokol stressed that while some perceive a trade-off between safety and competitiveness, particularly in contrast with more lenient systems like that of the United States, the EU’s standards are a core strength. He argued that competitiveness can be improved without diluting safety by cutting red tape and accelerating access to market for safe, proven technologies.

Learning from Global Models

Drawing on international comparisons, Jeroen Groenewegen-Lau from the Mercator Institute for China Studies highlighted China’s approach to biotech regulation. Per Euractiv, Groenewegen-Lau described China as a nation with both a stringent regulatory framework and an efficient approval system, which it leverages to advance innovation and control its domestic market.

While cautioning against emulating some of China’s more exclusionary practices, he suggested that Europe could consider how streamlined approval processes and strategic procurement policies might be adapted to the European context. He also raised questions about how to attract foreign biotech firms to operate within the EU in a way that benefits both European markets and innovation ecosystems.

Towards a Biotech Strategy That Balances Security and Growth

The roundtable illuminated a shared understanding among European stakeholders: that the path forward must protect both public welfare and economic ambition. As the EU continues developing its biotech policies, including the anticipated Biotech Act, the focus remains on refining regulatory frameworks that uphold safety while enabling scalable innovation.

According to Euractiv, there’s a growing consensus that biosecurity isn’t a barrier to innovation—it’s a foundational pillar that can propel Europe toward a more resilient and competitive biotech future.

Source: Euractiv