What Is the EU Biotech Act?

In March 2024, the European Commission launched the EU Biotech and Biomanufacturing Initiative, aiming to strengthen Europe's leadership in biotechnology. This initiative recognizes biotech as a key driver in tackling challenges in healthcare, agriculture, energy, and sustainability. Its objectives include:

• Scaling up EU biotech innovation

• Removing regulatory bottlenecks

• Promoting investment

Leveraging emerging technologies, including Artificial Intelligence (AI)

In May 2025, the Commission opened a call for evidence and public consultation to guide the development of the legislative proposal. This proposal—expected in 2026—will form the basis of what is commonly referred to as the EU Biotech Act.

We at Kantify are excited to see AI and data featured as core enablers in the themes identified by the Commission. As a company pioneering AI-driven drug discovery, we are honored to contribute to shaping Europe’s biotech future.

Kantify’s Contribution: Advocating for AI-Enabled Biotech

Our response to the consultation outlines the transformative role of AI in biotechnology, based on our deep experience in drug discovery for human and plant health. We emphasize three strategic areas:

1. Demonstrating the Value of AI in Drug Discovery

We provided concrete, cross-sector examples of how AI drives innovation:

In human health, our proprietary platform Sapian predicts off-target interactions across the human proteome, helping to identify safer, more effective drugs faster.

In plant health, AI models accelerate the discovery of safer and more sustainable plant protection agents.

These use cases show how AI reduces time-to-discovery, expands scientific insight, and unlocks novel mechanisms that traditional methods often miss.

2. Enabling Smarter Risk Management in Product Development

Biotech development is fraught with uncertainty. AI is a key ally in de-risking pipelines by:

Flagging non-viable compounds early

Prioritizing multi-target molecules for complex diseases

Enabling better-informed go/no-go decisions at preclinical stages

The ability to test, iterate, and simulate in silico reduces cost and increases the probability of success—both vital for Europe’s biotech competitiveness.

3. Advancing AI Integration in Regulatory Processes

We believe that regulatory innovation must evolve in tandem with scientific innovation. Drawing from early developments in the United States, we recommend that the EU:

• Expand the role of AI in evidence assessment, safety evaluation, and documentation

• Establish digital sandboxes and clear guidance for AI use in regulatory submissions

• Foster transparency and trust by investing in technical expertise within EU agencies

Europe has a real opportunity to lead in regulatory AI-readiness, creating a fair, science-based environment that rewards innovation without compromising safety.

Building Europe’s Biotech Future

The forthcoming EU Biotech Act represents a generational opportunity. At Kantify, we strongly believe that AI will be central to the next era of biotechnology—not just in the lab, but in how we regulate, evaluate, and bring innovations to society.

We look forward to continued collaboration with regulators, industry, and research partners to help Europe fulfill its ambition of becoming a global leader in biotech—scientifically bold, digitally empowered, and socially responsible.