The European Parliament's joint SANT-ITRE committee on 29 June 2026 considered the draft report on the European Biotech Act, with co-rapporteurs Vytenis Povilas Andriukaitis (S&D) and Wouter Beke (EPP) presenting their proposals. Shadow rapporteurs from across the political spectrum diverged on key issues including supplementary protection certificates (SPCs), scope, and clinical trial timelines.
Andriukaitis stressed the need to translate research into patient access, proposing a clinical trial expert committee, accelerated procedures for rare diseases, and a European biotech scale-up fund. Beke highlighted biotech's geopolitical importance and proposed reducing administrative burden for strategic projects, allowing single-member-state projects to qualify.
Shadow rapporteurs staked out different positions. Ingeborg Ter Laak (EPP) welcomed the focus on innovation and data but sought further improvements for clinical research and investment. Dario Nardella (S&D) pushed for more ambitious clinical trial timelines, noting the current 75-day target compares unfavourably to 30 days in the US, UK, and China, and cautioned against broad SPC extensions without evidence. Margarita de la Pisa Carrión (PfE) stressed balancing innovation with safety and human dignity, questioning the practical difference between strategic project categories. Kristoffer Storm (ECR) called for technology-neutral SPC extensions and more ambitious incentives, including 24-month extensions. Stine Bosse (Renew) warned Europe is losing ground to the US and China, proposing a '28th regime' for centralized ethics assessment in clinical trials and fast-track for orphan drugs. Katri Kulmuni (Renew) supported broader scope but cautioned against geographic concentration of strategic projects. Ville Niinistö (Greens-EFA) insisted public support must tie to affordable access and transparency, opposed SPC extensions, and argued scope should be limited to health biotech for now.
The debate exposed a cleavage between those prioritising innovation incentives (ECR, Renew, some EPP) and those emphasising access and safety (Greens-EFA, S&D). SPC extensions divided the committee: ECR and some Renew MEPs supported them, while Greens-EFA and S&D opposed or urged caution. Scope also split MEPs, with Greens-EFA favouring a narrow health focus and others backing a broader definition.
shadow rapporteurs will table amendments by 7 July, with further negotiations ahead. The outcome will affect biotech firms facing regulatory costs, patients seeking faster access to therapies, healthcare systems balancing innovation and affordability, and investors assessing market certainty.