European Biotech Act and accompanying Directive on genetically modified micro-organisms

Key points

The EESC:

1. calls for focused investment in health biotechnology R&I and production, stronger EU support for biotech clusters and their scale-up tools, and for the EU biotech strategy to be embedded across related EU initiatives;
2. considers that the European Medicines Agency should be the sole EU authority for pharmaceutical licensing, and welcomes regulatory sandboxes with definitions aligned to the EMA and testing of social acceptability;
3. supports one-year SPCs where the product is innovative, EU-produced, and offers a significantly different mechanism with safety and efficacy at least equivalent to existing EU-authorised treatments for the same disease;
4. welcomes the two-year ‘capital booster’ pilot and calls for a permanent late-stage tool, with the EIB channelling finance, more harmonised capital rules, stronger academia–industry transfer, and a streamlined Support Network with additional financing and no duplication;
5. supports ‘digital by default’ and proportionate AI use in clinical trials, and welcomes improvements to the EU clinical trial system, while calling for a simple, clear and predictable framework, better alignment with EU digital and AI strategies, and human decision-making;
6. welcomes the biosafety focus and calls for traceability and international cooperation on sensitive technologies, with proportionate controls such as end-user licensing and drug-precursor-type procedures; and for GMM-based innovation, case-by-case risk assessment under the precautionary principle and safeguards for detectability and reversibility;
7. warns simplification must not become deregulation; calls to uphold worker, environmental and OSH protections; and calls for strict, independent pre-market evaluation of biotech applications, including biosecurity and bioethical concerns, backed by adequate EU funds to avoid delays;
8. underlines the role of preventive medicines; calls to strengthen vaccine research infrastructure and coordination; recommends fast-track, proportionate and inclusive pathways for paediatric and rare-disease trials; and calls for inclusive stakeholder dialogue and better coordination of national medical ethics committees.