Source: European Parliament
The new European biotech act, announced in Ursula von der Leyen’s political guidelines for 2025, was not included in the Commission work programme published on 11 February, but has recently been announced for early 2026. Strong uncertainty on the timing and scope of the biotech act have existed since the initial announcement. The Commission ordered a complex study to provide a foundation for the act only in early 2025, and it has become evident that discussions about the scope, key components, and timeline of the new European biotech act were still at an early stage. Expectations about the possibility for the Danish Presidency to initiate the discussions on the biotech act in the second half of 2025 have therefore faded. A key area of debate among stakeholders – from research to manufacturing, but also Member States – is the scope of the act. Concerns have been raised about the possibility that Commissioner Várhelyi and DG SANTE (currently leading on this file) might limit it primarily to healthcare, potentially overlooking the biotech industry’s broader potential in critical sectors including defence, energy, agriculture, and climate change mitigation. The European Parliament has the opportunity to use the time until a draft is presented to be proactive and use its tools to shape the proposal (see below), aiming for a comprehensive approach that encompasses biotech’s full impact across essential sectors. Discussions are currently taking place in the Committee on Public Health (SANT) and the Committee on Industry, Research and Energy (ITRE), to demonstrate that it is about strengthening a competitive comprehensive European biotech sector.