The Council of the European Union's Working Party on Pharmaceuticals and Medical Devices is scheduled to meet on 9 and 10 July 2026 in Brussels to exchange views on the proposed European Biotech Act, according to a notice of meeting and provisional agenda published on 25 June 2026. The meeting, to be held at the Justus Lipsius Building, will focus on the Commission's proposal for a regulation establishing a framework to strengthen the Union's biotechnology and biomanufacturing sectors, particularly in health, and amending several existing regulations.
an exchange of views on the Proposal for a Regulation (reference document ST 16945/25) that would create the European Biotech Act. The proposal aims to boost EU biotechnology and biomanufacturing in health, amending regulations on food safety, advanced therapy medicinal products, clinical trials, veterinary medicinal products, and other related legislation. The Working Party's discussion will feed into the Council's position on the file, which is part of the ordinary legislative procedure.
No prior coverage of this specific meeting or the European Biotech Act proposal exists in recent records, indicating this is a new legislative initiative. The meeting is scheduled to run from 10:00 each day, with a second day reserved for any other business. The Council's Health and Consumer Protection Directorate (LIFE.Health) is the contact point.
The European Biotech Act, if adopted, would have significant implications for stakeholders including EU biotech companies, which could benefit from streamlined regulations and incentives for innovation; national regulatory authorities, which would face new coordination requirements; and patients, who may gain faster access to advanced therapies. The proposal also impacts the pharmaceutical sector by amending key regulations on clinical trials and medicinal products. The Working Party's exchange of views is an early step in the legislative process, with the European Parliament expected to weigh in later. The Council's final position will depend on further discussions in the Working Party and the Permanent Representatives Committee (Coreper).