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Time: 12:30 - 12:45

KEYNOTE ADDRESS by Olivér Várhelyi, European Commissioner for Health and Animal Welfare

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Time: 12:45 - 13:30 CET

Panel 1: The EU Biotech Act - Europe's opportunity to reclaim innovation leadership

Europe's life sciences sector remains one of the continent's greatest scientific assets, yet concerns continue to grow over its ability to compete with increasingly attractive innovation ecosystems in the United States and Asia. Investment decisions, research activity and clinical development programmes are increasingly shaped by global competition, raising questions about whether Europe is providing the right conditions for innovators to develop and scale breakthrough technologies.

The forthcoming EU Biotech Act is widely seen as an opportunity to strengthen Europe's position as a destination for research, development and investment. By addressing regulatory complexity, supporting innovation pathways and improving the framework conditions for emerging technologies, the Act could help create a more competitive environment for companies developing the next generation of medicines and health technologies.

Particular attention is being paid to clinical research. Lengthy and fragmented approval processes have often been cited as barriers to conducting clinical trials in Europe, limiting the region's attractiveness compared with other global markets. As policymakers seek to accelerate innovation while maintaining high standards of safety and quality, the Biotech Act may play a pivotal role in determining whether Europe can once again become a leading destination for biomedical innovation.

Questions to be addressed:

- Can the Biotech Act provide the regulatory certainty and investment signals needed to strengthen Europe's life sciences competitiveness?

- How can the EU improve the speed and attractiveness of clinical trials while maintaining trust and high regulatory standards?

- What would success look like for the Biotech Act five years after its implementation?

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Time: 13:30 - 14:15 CET

Panel 2: From innovation to patients – Accelerating access to medicines in Europe

Scientific advances are opening new possibilities for treatment, yet patients across Europe continue to face significant differences in whether—and how quickly—they can benefit. National assessment and reimbursement processes, funding decisions and health system readiness all shape access to innovative medicines. Against a backdrop of constrained public finances and growing global competition, how can Europe translate medical progress into timely and equitable access? This panel will explore how policymakers, payers, patients and industry can address persistent barriers while balancing affordability, long-term value and incentives for future innovation.

Questions to be addressed:

- What are the main barriers delaying access to innovative medicines, and which national reforms could make the greatest difference for patients across Europe?

- How can healthcare budgets better reflect the long-term benefits of innovative medicines for patients, health systems and the economy, while managing immediate financial pressures?

- Could earlier access following regulatory approval, while national assessment and pricing processes are completed, offer a workable way forward? What safeguards and funding arrangements would be needed?

- How can patients play a stronger role in shaping access decisions, and what commitments should governments, payers and industry make to deliver measurable improvements?

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