Tuesday, October 7, 2025

10:15 - 11:00

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In her Political Guidelines, presented to the European Parliament in July 2024, Ursula von der Leyen announced a new European biotech act, that aims to 'bring biotech from the laboratory to the factory and then onto the market'. As a non-binding biotech initiative, the act aims to simplify regulatory processes for the life sciences sector. The initiative would include measures to simplify the regulatory landscape that currently hinders investment in the biotech sector, enhance financing options for start-ups/scale-ups, and ease the process of bringing research discoveries to market and enhancing access to big data and AI. Additionally, the act would seek to improve access to affordable, sustainable, and secure energy and raw materials, supporting all industries, including biotech, in achieving net-zero objectives. In the European Commission, the lead on this file is the Commissioner for Health and Animal Welfare (DG SANTE). Commissioner Várhelyi emphasised his commitment to advancing the biotech act, aiming to simplify regulatory environments, boost R&D, enhance skills, and attract investment, particularly in strategic areas such as clinical development and new production technologies. His focus also extends to supporting start-ups, SMEs, and spin-offs, which are crucial for innovation but often encounter challenges in scaling up and commercialising their research. Representatives from the industry are asking for faster financing mechanisms, simplified regulatory and operational frameworks, and strong, connected and skilled value chains. The industry also is keen to remind the Commission that it should not focus solely on healthcare and consider the biotech industry's broader role in sectors such as defense, energy, biomass, climate change, and CO2 emissions reduction. The also EU needs to be strategic and which parts of the supply chain to prioritize and invest in given recent geopolitical developments. The EU biotech act has been set to be proposed in early 2026, with no further indications on its scope. The Biotech act represents an opportunity to establish Europe as a global leader in biotechnology, for competitiveness and strategic autonomy. This roundtable invites representatives of the European Commission and the industry to provide each party’s perspective on the Act and and make contributions that will help in definining its scope and content.

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