AseBio joins the manifesto led by EuropaBio in support of Biotech Act II, crucial for biomanufacturing in Europe
We consider a Biotech Act II that improves coordination, facilitates market access, and accelerates industrial development to be key in transforming European scientific potential into economic leadership.
Desde la Asociación Española de Bioempresas (AseBio) nos hemos sumado al manifiesto impulsado por EuropaBio, la Asociación Europea de Empresas Biotecnológicas de la que somos miembro, para defender la biofabricación en la Unión Europea (UE) y la Biotech Act II, la segunda fase de la iniciativa legislativa europea destinada a fortalecer la biotecnología en el continente.
The Spanish Bioindustry Association (AseBio) has joined the manifesto launched by EuropaBio, the European Association of Biotechnology Companies of which we are a member, to defend biomanufacturing in the European Union (EU) and Biotech Act II, the second phase of the European legislative initiative aimed at strengthening biotechnology on the continent.
The manifesto comes in response to the identification in recent weeks of potential risks to Biotech Act II, including a scenario in which it might not materialize. The second phase of the law, to be led by Stéphane Séjourné, Vice-President of the European Commission, will focus on industrial policy and the creation of a broader, forward-looking ecosystem. It is expected in the third quarter of 2026.
The joint document, already signed by 44 European associations, emphasizes the urgent need for a Biomanufacturing Act that enables Europe to strengthen its global competitiveness. Despite being a key player in the bioeconomy and biopharmaceutical sectors, the European Union lacks a specific strategy, unlike powers such as the United States, China, or India.
The manifesto highlights the existing gap between biotechnological innovation and its industrial scale-up, worsened by regulatory fragmentation and duplication across countries and sectors, which limits development, investment, and the performance of the European market. Therefore, it proposes an ambitious framework that promotes coordination, facilitates market access, and encourages investment in large-scale production capabilities—transforming European scientific excellence into industrial leadership, strengthening supply chains, and ensuring sustainable growth of the EU bioeconomy.
“A Biotech Act II dedicated to biomanufacturing is the missing piece for the EU to be globally competitive in this vital technology. It is essential to strengthen all sectors with a solid European market, cutting-edge capabilities, and ensuring it becomes the natural investment choice for companies in our leading industries. We must create our own destiny in biomanufacturing, rather than merely watching it unfold elsewhere, and the work is far from finished,” stated Claire Skentelbery, Director General of EuropaBio.
At AseBio, we emphasize that in the current global context, where other powers are advancing rapidly, Europe needs an ambitious initiative to enable competition. Our sector still faces challenges such as regulatory fragmentation and duplication. For this reason, we consider a Biotech Act II that improves coordination, facilitates market access, and accelerates industrial development to be key in transforming European scientific potential into economic leadership.