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.

Switzerland's Federal Council promulgated the Verordnung über die Mindestbesteuerung grosser Unternehmensgruppen (Mindestbesteuerungsverordnung, MindStV; French: OIMin), SR 642.161, AS 2023 841, on 22 December 2023, with effect from 1 January 2024. The ordinance enacts a 15% Qualified Domestic Minimum Top-up Tax (QDMTT — Ergänzungssteuer) on Swiss constituent entities of MNE groups with consolidated annual revenue ≥ EUR 750 million, enacted under the temporary constitutional authority granted by Swiss voters in a popular referendum on 18 June 2023 (78.5% yes, Art. 129a BV). The Income Inclusion Rule (IIR) and Undertaxed Profits Rule (UTPR) were deliberately deferred to subsequent ordinance amendments, targeting FY 2025 phasing. The Swiss Federal Tax Administration (ESTV / AFC) is the administering authority; first QDMTT returns and GloBE Information Returns due 30 June 2026.