Industrial Policy & Trade Monitor· 2662 actions· ✨ 89 recent

The European Investment Bank signed a EUR 90 million loan with METLEN Energy & Metals SA on 19 December 2025 (publicly announced 15 January 2026), financing modernisation of METLEN's bauxite mining operations in the Parnassus-Giona area and the construction of Europe's first EIB-financed gallium production line at the company's Aluminium of Greece complex in Agios Nikolaos, Viotia. The financing is provided under the REPowerEU framework and is explicitly framed by the EIB as supporting EU Critical Raw Materials Act (CRMA) objectives and reducing reliance on non-EU gallium supply. It is the third EIB financing extended to METLEN.

On 16 December 2025 the European Commission adopted in Strasbourg the Proposal for a Regulation establishing a framework of measures for strengthening the Union's biotechnology and biomanufacturing sectors particularly in the area of health — the "European Biotech Act" (COM(2025) 1022 final). The proposal is the third axis of the EU's pharma/biotech industrial-policy stack alongside the Critical Medicines Act (filed: 2025-03-11-eu-critical-medicines-act-proposal) and the US Section 232 pharmaceuticals track (filed: 2026-04-02-us-section-232-pharmaceutical-proclamation), and is explicitly designed to keep biotech innovation, investment, and biomanufacturing capacity in Europe in the face of US/China competitiveness pressure. Core instruments: (1) statutory recognition for "Health Biotechnology Strategic Projects" (HBSPs) and "High-Impact" HBSPs eligible for accelerated permitting via a single national contact point, plus administrative/technical/ financial support; (2) regulatory sandboxes for novel biotech and biomanufacturing modalities; (3) a 12-month Supplementary Protection Certificate extension for qualifying biotech and advanced-therapy medicines; (4) targeted simplification of existing EU life-sciences acquis (clinical-trial timelines, risk-proportionate requirements); (5) an EU Health Biotechnology Investment Pilot co-developed with the EIB Group, paired with a EUR 10bn 2026-27 EIB-Commission financing initiative; (6) biosecurity safeguards including a list of "biotechnology products of concern" and mandatory built-in screening for benchtop nucleic-acid synthesis devices. A second tranche covering industrial biotechnologies and biomanufacturing outside health is expected later in 2026.

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.

On 11 March 2025 the European Commission published its proposal for a Critical Medicines Act (CMA), pillar of the broader EU pharmaceutical-resilience agenda alongside the EU Critical Raw Materials Act (filed: 2024-05-23-eu-crma-entry-into-force) and the IRA-style industrial-policy stack. The proposal targets supply security of an EU "Union List" of critical medicines (antibiotics, anti-thrombotics, oncology, cardiovascular, insulin, painkillers) by introducing four mechanisms: (1) Strategic Project status with expedited funding access for critical-medicine manufacturing or active-substance production; (2) public-procurement preferences favouring resilient supply chains and — in defined cases — EU-based production; (3) collaborative cross-Member-State procurement to address fragmented small markets; (4) state-aid framework guidance + international-partnership diversification to reduce single-country (often China-routed) API dependency.

Regulation (EU) 2024/2847 of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements, signed 23 October 2024 and entering into force 10 December 2024. The CRA is the first EU statutory cybersecurity regime covering all hardware and software products with a direct or indirect data connection placed on the EU market, imposing essential cybersecurity requirements, conformity assessment with CE marking, mandatory vulnerability handling, and 24-hour early-warning notification of actively-exploited vulnerabilities to ENISA. Main manufacturer obligations apply from 11 December 2027; conformity-assessment-body notification provisions apply from 11 June 2026 and reporting obligations from 11 September 2026. Penalties reach EUR 15M or 2.5% of global annual turnover.

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.

Commission Delegated Regulation (EU) 2023/66, adopted 21 October 2022 and published in the Official Journal on 11 January 2023 (OJ L 9), replaces Annex I of Regulation (EU) 2021/821 (the EU Dual-Use Recast Regulation) with an updated control list implementing the 2022 multilateral decisions of the Wassenaar Arrangement, MTCR, Australia Group, NSG and the Chemical Weapons Convention. Per GTA's tracking of the CN-code-level change, the update removed 7 six-digit CN codes and added 8 new ones. It entered into force on 12 January 2023, the day after publication.

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.).

Regulation (EU) 2021/821, adopted 20 May 2021 and applied from 9 September 2021, establishes the Union regime for controlling exports, brokering, technical assistance, transit, and transfer of dual-use items, repealing Regulation (EC) No 428/2009. Annex I lists controlled items implementing internationally agreed dual-use controls under the Wassenaar Arrangement, MTCR, Australia Group, NSG, and Chemical Weapons Convention. The regulation introduces a new catch-all control on cyber-surveillance technologies that could facilitate human-rights violations (Art. 5 and Annex IV), and strengthens cooperation between Member States and the European Commission, placing specific obligations on exporters. It serves as the statutory anchor for all EU export licences, every multilateral-regime transposition into EU law, and coordination mechanisms with US BIS, UK ECJU, JP METI, and KR MOTIE export-control regimes.