AseBio

AseBio welcomes the European Commission's proposal to develop Regime 28 and create the EU Inc. framework, an initiative that will allow innovative companies to operate under a single, harmonized set of company rules across the European Union.

ASEBIO's contribution to this consultation directly addresses the identified challenges and opportunities within the biotech sector. Our recommendations are structured around three key pillars, aligned with the broader European industry consensus, to build a resilient, competitive, and globally attractive biotech ecosystem, based on a single regulatory framework: 1) regulatory simplification and agility to…

AseBio welcomes the Proposal for a Directive COM(2025) 1031 final, amending Directives 2001/18/EC and 2010/53/EU, as a necessary first step to adapt the regulatory framework for genetically modified microorganisms (GMMs) to scientific and technological progress and to current biotechnology applications.

AseBio welcomes the European Commissions proposal for a European Biotechnology Act and supports its objective of strengthening Europes biotechnology and biomanufacturing sectors. However, several provisions should be clarified and harmonised to ensure effective implementation, legal certainty and global competitiveness.

AseBio welcomes the Biotech Act II as an opportunity to provide the EU with a more coherent, competitive and operational framework for industrial biotechnology and biomanufacturing. From our perspective, the initiative will only fully achieve its purpose if it is designed as a genuine instrument for industrial deployment. 1. Industrial deployment as the central priority.

The European Union must urgently overcome its innovation gap. While Europe boasts a world-class scientific base and a wealth of talent, its potential is consistently hampered by systemic barriers: regulatory fragmentation, obstacles to long-term financing, and a systemic talent shortage. These issues affect all innovative sectors, creating a significant competitive disadvantage compared to other global powers.

Spanish biotechnology, characterised by a dynamic ecosystem of start-ups, innovative SMEs and companies specialising in personalised medicine and advanced diagnosis, welcomes the Commission’s proposal for a regulation to harmonise the quality management requirements and procedures applicable to notified bodies under Regulations (EU) 2017/745 and 2017/746.

Filed in Spanish · English published by the European Commission

The current legal framework needs to be modified to avoid its pernicious effects on the ability of companies that develop innovative technologies, start-ups and scale-ups, to gain access to national public financing in Europe.

AseBio, the Spanish Bioindustry Association, represents the Spanish biotechnology sector, brings together a diverse ecosystem of over 300 entities, including innovative small and medium-sized enterprises (SMEs), large corporations, and other vital players. AseBio warmly welcomes the post-2027 Multiannual Financial Framework (MFF) and for the next generation of financial programme.