JBCE Position Paper on the EU Biotech Act
On 16 July 2026, JBCE submitted its position paper on the EU Biotech Act.
JBCE supports the proposal's ambitious and innovation-oriented framework for strengthening the competitiveness of the EU's biomanufacturing sector. In particular, we welcome the proposal's commitment to rewarding innovation, as well as its measures to foster a more innovation-friendly regulatory environment, strengthen access to scale-up capital, accelerate and simplify clinical trials, and promote biomanufacturing in the EU. We believe these objectives can be achieved more effectively by also attracting investment from outside Europe, strengthening cooperation with trusted partners, and ensuring smooth market access for innovative products.
JBCE therefore calls on the co-legislators to:
- Strengthen investment incentives and cooperation with trusted partners by making the SPC extension conditions under Article 27 more flexible, ensuring they function as an effective and non-discriminatory incentive for investment, while better recognising the strategic value of trusted partners through the Strategic Projects criteria (Article 3) and broader international cooperation under Article 30.
- Broaden the definition of “biomanufacturing” (Article 2(1)(5)) to cover not only commercial-scale manufacturing but also clinical-stage production and technology transfer, which are essential to bridging research and commercial production.
- Simplify, clarify and ensure the feasibility of regulatory requirements by delivering genuine harmonisation of clinical trials across Member States, clarifying and keeping proportionate the biosecurity provisions in Chapter VIII, and ensuring coherence and clear prioritisation across overlapping frameworks, particularly for the use of AI.
For more information, please contact info@jbce.org