The EPSCO Council on 16 June 2026 debated the European Biotech Act, with the Cyprus Presidency framing the directive as a competitiveness priority. Commissioner Olivér Várhelyi urged rapid progress on biotech, faster trials, and a conditional one-year supplementary protection certificate (SPC) extension. Most member states supported the general approach, but Poland, Austria, Slovakia, and Hungary raised concerns. Poland demanded post-marketing monitoring and member-state involvement in delegated acts; Austria abstained due to missing monitoring requirements; Slovakia opposed the presumption of safety and expedited procedure; Hungary abstained over unresolved GMM classification and excessive Commission powers. Italy pushed for stronger personal-data exchange for organ processing, while Belgium insisted on preserving national competent authorities' roles.
On clinical trials, Germany, Denmark, and Belgium backed faster processes, while Spain, Slovenia, and Bulgaria stressed ethics committee roles and participant protection. On strategic projects, Estonia warned against extra governance layers, and Poland wanted balancing mechanisms. On SPC extension, Italy, Poland, Malta, and the Netherlands warned of higher costs and delayed biosimilars, while Austria and Czechia supported it. On medical devices, Portugal, Greece, and others backed simplification, but Czechia rejected full refurbishing of single-use devices, and Italy opposed an EMA role in classification.
On AOB, Commissioner Várhelyi welcomed the provisional trilogue agreement on the Critical Medicines Act. On Ebola, Commissioner Hadja Lahbib urged source containment and opposed border closures. On wastewater producer responsibility, at least 16 member states, led by Germany and Greece, warned of unclear costs and supply risks; Commissioner Várhelyi acknowledged concerns. Next steps: Ireland will pursue clinical-trials amendments and medical device reform.
The debate exposed a split between member states prioritising competitiveness and those emphasising safety and national oversight. The SPC extension could boost biotech innovation but raise costs for biosimilar producers and healthcare systems. Faster clinical trials may accelerate patient access but risk undermining ethics committee safeguards. The outcome will shape the final directive and regulation, affecting biotech firms, patients, national health systems, and pharmaceutical supply chains.