Industrial Policy & Trade Monitor· 2666 actions· ✨ 90 recent

Section 851 of the FY 2026 National Defense Authorization Act (P.L. 119-60), signed December 18, 2025, prohibits US federal agencies from procuring biotechnology equipment or services from designated "biotechnology companies of concern" (BCCs), and bars federal contractors from using such equipment/services in work performed under federal contracts, grants, or loans. The final enacted text ties initial BCC designations to DoD's existing §1260H Chinese-military-company list (which currently includes BGI and MGI, but not WuXi AppTec or WuXi Biologics) and directs OMB to designate additional BCCs within one year of enactment; operational prohibitions activate 60-90 days after FAR revision, with a five-year grandfather period for pre-existing contracts — enforcement is expected to begin in 2027-28. The legislation is the successor to H.R.8333 (118th Congress, House-passed September 2024 but stalled in the Senate before adjournment) and represents the first enacted US federal-procurement biotech-supply-chain-resilience statute.

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 24 November 2025, six Beijing municipal departments — the Bureau of Economy and Information Technology, Development and Reform Commission, Science and Technology Commission, Health Commission, Drug Administration and Medical Insurance Bureau — jointly issued Notice 京经信发〔2025〕50号 ("Several Measures to Promote High-Quality Development of the Beijing Medical Device Industry"), effective immediately through 31 December 2028. The 15-measure package subsidises the full medical-device value chain: early-stage innovation (up to RMB 1m per project), product approval/launch (up to RMB 2m per product, RMB 10m annual enterprise cap), industrial-park and public-service infrastructure construction (up to 50% of investment, capped at RMB 50m), supply-chain-resilience R&D for critical components/materials (up to 30% of investment, capped at RMB 30m), AI-diagnostic-model development (up to RMB 30m), smart-factory digitalisation (up to 30% of investment, capped at RMB 30m per project), and international regulatory approval/market entry (up to RMB 1m per product, RMB 3m annual cap; up to RMB 10m for introducing overseas products to China).

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.