The Romanian Senate has issued an opinion on the proposed European Biotech Act, concluding that the draft regulation respects the EU principles of subsidiarity and proportionality. The opinion, sent to the Council of the European Union and received on 1 July 2026, was published as a Council cover note on 14 July 2026. The Romanian Senate's assessment focuses on the Proposal for a Regulation establishing a framework to strengthen the EU's biotechnology and biomanufacturing sectors, particularly in health, and amending several existing regulations (European Biotech Act). The opinion, accompanied by a courtesy English translation, finds no grounds to challenge the EU-level action on subsidiarity or proportionality grounds.
The European Biotech Act, proposed by the European Commission, aims to boost the EU's biotechnology and biomanufacturing capacity, with a focus on health applications. The regulation would amend key pieces of EU legislation, including Regulations (EC) No 178/2002 on food law, (EC) No 1394/2007 on advanced therapy medicinal products, (EU) No 536/2014 on clinical trials, (EU) 2019/6 on veterinary medicinal products, (EU) 2024/795 on the Strategic Technologies for Europe Platform (STEP), and (EU) 2024/1938 on health technology assessment. The Romanian Senate's positive opinion on subsidiarity and proportionality is a procedural step in the EU legislative process, where national parliaments can raise objections if they believe an EU proposal oversteps its competence. No other national parliament has issued a reasoned opinion on this proposal within the eight-week scrutiny period, which expired in early July 2026. The Council will now proceed with its examination of the proposal, with the European Parliament expected to adopt its position in the coming months. The Romanian Senate's endorsement removes one potential hurdle, but the file remains subject to the ordinary legislative procedure, requiring agreement between the Council and the European Parliament before adoption.