The Portuguese Parliament (Assembleia da República) has formally submitted its opinion on the proposed European Biotech Act (COM (2025) 1022 final), assessing the draft regulation's compliance with the Principles of Subsidiarity and Proportionality. The opinion was received by the Council of the European Union on 2 July 2026 and circulated as document 11851/26 on 14 July 2026.
The opinion concerns the European Commission's proposal for a Regulation establishing a framework to strengthen the EU's biotechnology and biomanufacturing sectors, particularly in health, and amending six existing Regulations. The Portuguese Parliament's assessment is part of the subsidiarity and proportionality scrutiny mechanism, which allows national parliaments to review draft EU legislation for compliance with these principles.
The full text of the opinion, in Portuguese and English, has been enclosed for delegations. A translation may be available on the IPEX website. The opinion does not indicate whether the Portuguese Parliament raised objections or supported the proposal; the document merely records its submission.
This development follows the Commission's publication of the European Biotech Act proposal, which aims to boost the EU's biotechnology and biomanufacturing sectors, with a focus on health applications. The proposal amends several existing regulations, including those on novel foods, advanced therapy medicinal products, clinical trials, veterinary medicinal products, and the Strategic Technologies for Europe Platform (STEP).
The national parliament scrutiny process is a key element of the EU's legislative procedure, allowing member states' parliaments to assess whether EU action is necessary and proportionate. The Portuguese Parliament's opinion will be considered by the Council and the European Parliament as they deliberate on the proposed regulation.
Stakeholders impacted by the proposal include EU biotechnology companies, which may face new compliance requirements but also benefit from a harmonized framework; national regulatory authorities, which will need to adapt to amended regulations; healthcare providers and patients, who may gain access to innovative therapies; and EU taxpayers, who may fund support measures under the framework. The opinion's focus on subsidiarity and proportionality suggests that the Portuguese Parliament is scrutinizing whether the EU's intervention is justified and not overly burdensome.
The Council will take note of the opinion, and the European Parliament will consider it during its legislative work. The Commission may also respond to any concerns raised by national parliaments.