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 modernization. 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 modernizing 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 prioritizing innovation incentives (SPCs, faster approvals) and those emphasizing public health safeguards and competition. Biotech firms would benefit from SPC extensions and faster EFSA approvals, potentially boosting investment, but consumer and patient groups may face higher drug prices and reduced trust if novel foods are fast-tracked without robust risk assessment. Health systems could see faster access to innovative therapies but also higher costs from extended monopolies. The final opinion will feed into the lead committee's report, with the Commission expected to present a legislative proposal later this year.