Overview
The file concerns the development of a Strategy for European Life Sciences, which is an upcoming policy initiative. The procedure is at a pre‑proposal stage, with the European Commission’s call for evidence currently open. The initiative falls under the responsibility of the Directorate‑General for Research and Innovation (RTD), with Commissioner Ekaterina Zaharieva leading the portfolio. The Council configuration involved is the Competitiveness Council (COMPET). The analysis is based on the provided data regarding procedural status, institutional handling, calendar events, and stakeholder outreach and positions.
Legislative timeline
The initiative is in its preparatory phase. The European Commission has opened a call for evidence, indicating that the drafting of a formal proposal is underway. An upcoming milestone is scheduled for 30 September 2026, when the Commission’s 2026 Commission Work Programme is expected to include the “European Biotech Act II,” which appears to be a legislative component or follow‑on to the broader life sciences strategy.
Institutional handling
The European Commission’s Directorate‑General for Research and Innovation (RTD) is the lead service developing the strategy, under the responsibility of Commissioner Ekaterina Zaharieva. In the Council, the dossier will be handled by the Competitiveness Council (COMPET), which covers research, innovation, and internal market aspects relevant to life sciences.
Stakeholder reactions
Stakeholder engagement has been active during the preparatory phase. A total of 86 meetings have been held between stakeholders and EU institutions: 4 with Members of the European Parliament, 19 with Commissioners, and 63 with European Commission staff. These meetings involved 31 distinct organisations. The most frequently engaged stakeholders include FIPRA International, the European Molecular Biology Organization, the European Food Forum, Sartorius Stedim Biotech GMBH, and Global Life Sciences Solutions Operations UK Ltd (trading as Cytiva).
From the recorded meeting topics, several stakeholder positions have been articulated on issues relevant to the regulatory environment for life sciences. On financial regulation, SwissRE, Allianz, MAPFRE, and Vanguard Asset Management Limited have expressed support for positions that oppose a strict “brown penalising factor” for fossil fuels under Solvency II and favour industry involvement in stress‑test design, indicating a preference for permissive capital rules. On the overall simplification of regulation in the EU, EU/ACC strongly supports simplifying company registration, Eni S.p.A. shows support for regulatory simplification in the context of ESRS revision, Bio.be/essenscia strongly calls for regulatory simplification as a key component of the Biotech Act II, and EuropeanIssuers also supports simplifying regulation. Regarding EU Single Market harmonisation, Eurochambres strongly advocates extending the Payment Accounts Directive to businesses to remove cross‑border banking barriers.
Media coverage
No media coverage data is provided in the database for this file.