The EPSCO Health Council on 16 June 2026, chaired by the Cyprus Presidency, reached a general approach on the European Biotech Act directive, the first legislative deliverable of the file. Commissioner for Health and Food Safety Olivér Várhelyi praised the package as a record-speed achievement tied to competitiveness and supply security, but disputes emerged over the lack of an ex ante impact assessment. Several ministers questioned the omission, particularly regarding the supplementary protection certificate (SPC) extension for biotechnological inventions. Várhelyi rejected calls for further delay, citing an existing impact analysis and warning that delay risks losing industry. On industrial anchoring vs. affordability, Cyprus stressed preserving universal access without undermining public health budgets, while Várhelyi emphasized keeping innovation and manufacturing in Europe. On EU-level coordination, Cyprus reported calls for greater cooperation, but Várhelyi firmly noted that health system organization remains a national competence. Regarding external pressures like most-favoured-nation (MFN) treatment, Cyprus and Várhelyi indicated that member states tasked the Commission with analysis rather than immediate action, with a commitment to deliver before summer. On SPC extension, Várhelyi defended it as targeted for biotechnological inventions with conditionalities, downplaying cost concerns. On health security, Várhelyi confirmed ministers' support for ECDC and Health Security Committee work on Ebola. On the urban wastewater treatment directive, Várhelyi urged careful implementation to avoid shortages or offshoring. Consensus included broad support for the Critical Medicines Act, biotechnology as strategic, and simplifying medical devices rules. Next steps: Cyprus will compile views into a note for the incoming Irish Presidency, and the Commission will produce an MFN analysis before summer. Affected stakeholders include pharmaceutical companies, national health systems, patients, and biotech innovators.