The Council of the European Union has published a contribution from Denmark offering technical amendments to the proposed 'One Substance One Assessment' (OSOA) data platform regulations, focusing on data governance, Member State involvement, and the exclusion of confidential medicinal product data. The comments, submitted under the 2023/0453-0455 COD legislative proposals, aim to streamline chemical assessments across EU regulatory frameworks while addressing commercial and patient safety risks.
Denmark's Proposals on Data Governance and Implementing Acts
Denmark's submission clarifies data protection roles between the European Commission and EU agencies, advocating for greater use of implementing acts over delegated acts for technical decisions. The delegation argues that implementing acts ensure stronger Member State oversight, reflecting a preference for intergovernmental control over Commission-led rulemaking. This position aligns with broader Council debates on the balance between efficiency and national sovereignty in EU chemicals regulation.
Exclusion of Confidential Medicinal Product Data
A key concern raised by Denmark is the inclusion of confidential medicinal product data in the common data platform. The delegation warns that such inclusion could jeopardize commercial confidentiality and patient safety, urging the Commission to exclude this data category. This highlights a tension between transparency in chemical assessments and protection of intellectual property and health data.
Interplay with EU Indicator Framework for Chemicals
Denmark also questions the relationship between the proposed legislation and the recently published EU indicator framework for chemicals, seeking clarification on whether the regulation codifies existing work. This reflects a broader need for coherence between new legislative instruments and existing policy frameworks.
Impact on Stakeholders
The proposed amendments would affect several stakeholders. EU regulatory bodies (ECHA, EFSA, EMA) would face clearer data governance rules and potential restrictions on accessing medicinal product data, impacting their assessment workflows. National authorities in EU member states would gain stronger oversight through implementing acts, increasing their role in technical decisions. Pharmaceutical companies would benefit from enhanced protection of confidential data, reducing risks of commercial espionage. However, EU chemical producers and downstream users may face delays in assessments if data sharing is limited, potentially slowing market access for safer chemicals.
Institutional Follow-Up
The European Commission will consider Member State comments as it revises the proposals. The European Parliament is expected to adopt its position in the coming months, with trilogue negotiations likely to focus on data governance and confidentiality provisions. The Council's Environment Working Party will continue technical discussions.
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