A discussion paper from the Trio Presidency, published on 24 July 2026 for the Working Party on Competitiveness and Growth meeting on 7 September 2026, sets out policy challenges and questions for EU Member States on scaling up industrial biotechnology, ahead of the forthcoming Biotech Act II. The paper identifies excessive regulatory complexity, lack of scaling finance, and poor commercialisation as key obstacles, noting that 66 out of 67 EU biotech companies that went public over six years listed on non-EU stock exchanges.
Policy Levers for Scale-Up and Market Growth', builds on the Commission’s 2025 EU Life Sciences Strategy, which aims for the EU to be the world’s most attractive location for life sciences by 2030. It notes that the EU bioeconomy was worth up to €2.7 trillion in 2023, employing 17.1 million people and generating €863 billion in value added. The forthcoming Biotech Act II will broaden the scope from the health-focused Biotech Act I to industrial biotechnology and biomanufacturing.
what industrial policy and regulatory levers are needed for scale-up and market demand, and what Member States can do nationally to implement levers cohesively. It highlights value chain obstacles and the need to translate research into globally competitive companies. The document serves as a preparatory step for the Working Party on Competitiveness and Growth, which will discuss these issues on 7 September 2026.
Stakeholder impact EU biotech companies stand to benefit from reduced regulatory fragmentation and improved access to scaling finance, which could lower barriers to growth and help retain companies within the EU. However, they may face transitional costs as new rules are implemented. National regulators will need to coordinate more closely, potentially increasing administrative burden. Investors could gain clearer signals for funding industrial biotech projects, but may face uncertainty until the Biotech Act II is finalised. EU consumers could see new bio-based products and processes, though market availability depends on successful scale-up.
Institutional follow-up The Working Party on Competitiveness and Growth will discuss the paper on 7 September 2026, with Member States expected to provide input on the policy levers. The Commission will then draft the Biotech Act II, which will be subject to the ordinary legislative procedure involving the European Parliament and the Council.