D.7.4 CROSS-FIELD REGULATORY ANALYSIS (Phase II)
Creators: name: Sganga, Caterina
name: Amram, Denise
name: Gennari, Francesca
name: ROSSI, ARIANNA
name: Blatti, Andrea
name: Turan, Pelin
Publisher: name: Zenodo
Year: 2024
Subjects: subject: Law
subject: FOS: Law

description: This Deliverable builds on D7.3 to illustrate the applicable legal framework impacting on BRIEF activities, providing a unique crossed-field analysis aiming at developing useful policies and recommendations for stakeholders and researchers. Contents are developed considering the results of the survey launched under the Deliverable D.7.2. on the engagement strategy as well as the evolution of the applicable legal framework, emerging from the multitude of legislative initiatives launched by the EU dealing with data-driven solutions and new technologies.

The report focuses on the mapping of the existing laws developing the ethical legal framework for the BRIEF ecosystem and its scientific community. In addition, it will pay tailored attention to the current legislative initiatives (not yet approved or entered into force) and their interpretative impact on Research & Development & Innovation sectors (hereinafter R&D&I). In fact, either EU Directives or EU Regulations shall be implemented / adapted to the existing sectorial national regulatory framework with different degrees of effectiveness in the Member States (hereinafter MS). Once applicable, EU Regulations, in fact, are directly effective in MS, but some provisions may find national implementations and interpretations. While EU Directives provides principles that need to be mandatory implemented in a national law of each MS. In addition to such legislative scheme, the EU identified new principles and obligations may directly impact on national (and even local) procedures of compliance even if the legislative initiative has not entered into force yet. In fact, in case of normative lacks, the interpretations provided in the working progress of the EU institutions may constitute a parameter to address decision-making processes and policies. This is the case of the so-called ethical legal compliance by design and by default, a principle that is mentioned in several legislative strategies impacting on research and innovation and finds new content thanks to sectorial interpretations. 

Therefore, a cross-field analysis of the existing normative constrains allows to identify interpretative gaps and enablers in tailored and concrete scenarios useful to develop practical policies and recommendations to solve common interpretative issues for BioRobotic-related activities. Together with this report, in fact, further 8 Policy Briefs (no. 9 to 16) are released to provide a more user-friendly perspective of the applicable legal framework (plus an update on the previously published policy brief no. 4). A panel has also been organised to better raise awareness on these matters and receive feedback from the BRIEF community of stakeholders and beyond.

To this end, this report constitutes a living document, including a preliminary analysis the application of specific principles into concrete scenarios relevant for the BRIEF RI and its stakeholders. It builds on D7.3 and will be further developed into D7.5.