The European Parliament's ENVI committee debated its opinion on the European Biotech Act on 23 June 2026, with members staking out divergent positions on intellectual property and regulatory speed. Rapporteur Nicolás González Casares (Spain, S&D) stressed the need to balance innovation with strategic autonomy, public health, and consumer protection. He supported regulatory sandboxes but opposed extending supplementary protection certificates (SPCs) without an impact assessment, arguing that monopolies do not guarantee innovation. Stine Bosse (Denmark, Renew) pushed for modernising EFSA's mandate to accelerate novel food approvals, citing EU reliance on imported proteins and vitamins. Martin Häusling (Germany, Greens/EFA) backed the rapporteur's call for balance, rejecting SPC extensions and excluding novel foods from sandboxes to protect consumer trust. He called for stronger EFSA resources and independent risk assessment. Vytenis Povilas Andriukaitis (S&D, co-rapporteur in the lead committee) welcomed the opinion and stressed faster clinical trials and pan-European projects.
Commission representative Cristina Modoran highlighted convergence on clinical trials and defended SPC extensions as a targeted, conditional tool requiring EU-based trials and manufacturing. The deadline for amendments is 25 June 2026. The debate exposed a cleavage between those prioritising rapid market access and those insisting on rigorous safeguards. For biotech firms, faster EFSA approvals and SPC extensions could reduce time-to-market and increase returns on investment, but may also raise costs if conditional manufacturing requirements are imposed. Patients could benefit from accelerated access to novel therapies and foods, though consumer trust may be undermined if risk assessment is perceived as weakened. Health systems may see improved strategic autonomy if EU-based production is incentivised, but could face higher drug prices if monopolies are extended. Food producers stand to gain from reduced reliance on imports, but may face stricter oversight if novel foods are excluded from sandboxes.