European Biotech Act 2

The proposed European Biotech Act aims to make Europe's health-biotechnology sector more competitive through easier funding, quicker regulatory processes and stronger safeguards. It would support industry, manufacturing and research, especially start-ups and SMEs; facilitate AI, data and digital solutions; simplify rules on clinical trials and cell and gene therapies; and introduce biosecurity measures. The Commission says the Act should help patients gain timelier, broader access to treatments and products. In 2026 it will address the wider biotechnology sector.