Industrial Policy & Trade Monitor· 2663 actions· ✨ 89 recent

In the early hours of 11 December 2025 the Council of the EU and the European Parliament reached provisional political agreement in trilogue on the "EU Pharma Package" — the revised pharmaceutical Regulation (COM 2023/0131) and Directive (COM 2023/0132) — the most significant overhaul of EU pharmaceutical legislation in over two decades. The package replaces Directive 2001/83/EC (Community Code on medicinal products for human use) and Regulation (EC) 726/2004 (the EMA Regulation), and consolidates the orphan-medicine (Regulation 141/2000) and pediatric-medicine regulations into a single framework. Headline provisions: (i) a new "8+1(+1)(+1)" IP-incentive architecture — 8 years of regulatory data protection plus 1 year of market protection, with up to two additional 12-month extensions for products addressing unmet medical need or new active substances meeting comparative-trial conditions, capped at 11 years total; (ii) an EU-wide list of critical medicines under enhanced governance via the Medicines Shortages Steering Group (MSSG) and an EMA "list of critical shortages in the EU"; (iii) mandatory shortage-prevention plans on marketing-authorisation holders for prescription medicines and Commission-designated products; (iv) modernisation of clinical-trial requirements, environmental-risk assessment, antimicrobial stewardship, and a transferable-exclusivity-voucher (TEV) regime to incentivise novel antibiotic R&D. The COREPER I committee endorsed the compromise text on 6 March 2026 and final adoption by Parliament and Council is expected during summer 2026, with the regulatory framework becoming applicable in 2028.

The Joint Committee of the European Supervisory Authorities (EBA, EIOPA, ESMA) published the Guide on DORA Oversight Activities (JC 2025 29) on 15 July 2025, the definitive operational description of how the ESAs will supervise Critical ICT Third-Party Providers (CTPPs) designated under DORA Art. 31. The guide establishes the governance of Joint Examination Teams (JETs), the oversight examination lifecycle (planning, risk assessment, binding recommendations, follow-up), penalty processes of up to 1% of average daily worldwide turnover per day of breach (DORA Art. 35(6)), and lead-overseer assignments (EBA for banking, ESMA for capital markets, EIOPA for insurance). It is authoritative ESA interpretive guidance, not legally binding per se, but constitutes the supervisory playbook CTPPs and their dependent financial entities must plan against.

The European Union's Artificial Intelligence Act, Regulation (EU) 2024/1689, was published in the Official Journal on 12 July 2024 and entered into force on 1 August 2024. It establishes the world's first horizontal, risk-tiered legal framework for the development, market placement, and use of AI systems — covering prohibited practices, high-risk systems, general-purpose AI models, and minimal-risk applications — with extraterritorial reach over any provider placing an AI system on the EU market or whose output is used in the EU. Penalties reach up to EUR 35 million or 7% of global annual turnover. Application is staged: prohibitions from 2 February 2025, GPAI and governance from 2 August 2025, the bulk of high-risk obligations from 2 August 2026, and product-safety-embedded high-risk systems from 2 August 2027.

Regulation (EU) 2023/2854 of the European Parliament and of the Council of 13 December 2023 on harmonised rules on fair access to and use of data — the "Data Act" — was published in the Official Journal on 22 December 2023, entered into force on 11 January 2024, and applies generally from 12 September 2025 (with longer transitional periods for IoT product-design obligations under Article 3(1), which apply to products placed on the market after 12 September 2026, and for the data-portability standardisation framework, applicable from 12 September 2027). The Data Act is the third pillar of the EU data-economy framework alongside the GDPR (personal data) and the Data Governance Act 2022/868 (data-intermediation services), and is the world's first horizontal statutory regime governing access to and portability of industrial / IoT / non-personal data — covering by-design data-availability obligations on connected-product manufacturers, a mandatory cloud- switching framework with progressive elimination of switching charges, B2G emergency data-sharing in exceptional needs, unfair-contract-terms protection for SMEs, and safeguards against unlawful international government access to non-personal data held in EU cloud.

Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance — the Data Governance Act (DGA) — was published in the Official Journal on 3 June 2022, entered into force on 23 June 2022, and became fully applicable on 24 September 2023. The DGA is the second pillar of the EU data-economy framework (alongside GDPR for personal data and the Data Act 2023/2854 for industrial/IoT data) and establishes four structural mechanisms: (i) a harmonised public-sector data re-use regime for protected data held by public-sector bodies; (ii) a mandatory notification and structural-separation regime for data-intermediation service providers; (iii) a voluntary recognition framework for data-altruism organisations (RDAOs); and (iv) the European Data Innovation Board (EDIB) to co-ordinate national competent authorities and advise on common European data spaces and interoperability standards. The regulation is the foundational parent statute of the existing French SREN law filing (2024-05-21) and functions as enabling legislation for the EU's sectoral common-data-space programme (Health, Agriculture, Finance, Mobility, Green Deal, Energy, etc.).