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

On 2 April 2026 President Trump issued a Presidential Proclamation under Section 232 of the Trade Expansion Act of 1962 ("Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States") imposing a 100% ad valorem tariff on imports of patented pharmaceutical products listed in the FDA Orange Book and Purple Book, together with the active pharmaceutical ingredients (APIs) and key starting materials used to make them. The base rate takes effect at 12:01 a.m. EDT on 31 July 2026 for the 17 manufacturers identified in Annex III, and on 29 September 2026 for all other companies. The proclamation adopts findings of the Section 232 investigation initiated by the Department of Commerce on 14 April 2025 into pharmaceuticals and APIs as a national- security supply-chain risk. The instrument is structured around a multi-tier rate ladder rather than a flat tariff: concessionary 15% rates for EU/Japan/South Korea/Switzerland/Liechtenstein under reciprocal-deal tracks, 10% for the UK with a pathway to 0% under the pending UK pharmaceutical agreement, a "+20%" surcharge for companies operating under a Commerce-approved onshoring plan (until 2 April 2030), and a 0% pathway for companies that combine an approved onshoring plan with an MFN-pricing agreement with HHS (until 20 January 2029). Generics, biosimilars and their ingredients, orphan drugs, nuclear medicines, plasma-derived therapies, fertility treatments, and cell/gene therapies are carved out.

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.

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.

President Trump signed Executive Order 14273, "Delivering Most- Favored-Nation Prescription Drug Pricing to American Patients", on 12 May 2025. The EO directs HHS, USTR, and Commerce to pursue mechanisms (negotiation targets, importation pathways, and trade-policy levers) to bring the prices Americans pay for innovative prescription drugs into alignment with the *lowest* prices paid by other comparably-developed nations — the "most-favored-nation" (MFN) benchmark. Unlike the Biden-era Inflation Reduction Act drug-price-negotiation provisions (which apply to a handful of Medicare Part D drugs), the EO applies pressure across the broader pharmaceutical pricing surface. As of April 2026, 17 major pharmaceutical manufacturers (incl. Eli Lilly, Pfizer, Bristol-Myers Squibb, AbbVie, Merck, AstraZeneca, Regeneron) have signed bilateral agreements bringing US drug prices toward the international- benchmark level for selected medications.

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.

On 16 January 2025 the US Bureau of Industry and Security published an interim final rule (90 FR 4598; FR Doc 2025-00723) creating new ECCN 3A069 for high-parameter flow cytometers and liquid chromatography mass spectrometers specially designed for top-down proteomics, plus new ECCN 3E069 for related development and production technology. Items previously controlled under the catch-all ECCN 3A999 are migrated into the dedicated 3A069 classification, which carries National Security (NS), Regional Stability (RS), and Anti-Terrorism (AT) controls. Licensing policy is presumption of denial for destinations in Country Group D:1 and D:5, Macau, and Country Group E (i.e. China, Russia, Iran, North Korea, Cuba, Syria, Venezuela). The rule also adds new EEI/AES filing requirements (§ 758.1(b)(11)) for all 3A069 exports to Country Group D destinations. Public comments were accepted until 17 March 2025.

On 23 December 2024 the US Bureau of Industry and Security published a final rule (89 FR 104408; FR Doc 2024-30425; RIN 0694-AJ83) amending the Export Administration Regulations to implement decisions adopted at the Australia Group's 2023 and 2024 plenary meetings. The rule adds new ECCN 2B352.k controlling instruments for the automated chemical synthesis of peptides that are partly or entirely automated and capable of generating peptides at a system-synthesis scale of 1 mmol or greater, finalising the April 2023 BIS proposed rule. It also adds dipropylamine to ECCN 1C350.d.11, neosaxitoxin to ECCN 1C351.d.12, revises the 1C351.d.3 entry from "botulinum toxins" to "botulinum neurotoxins" to capture all serotypes, adds a "minimum detection limit" definition for toxic-gas monitors in 2B351.a, and explicitly captures single-use centrifugal separators in 2B352.c. License requirements (CB, AT, CW where applicable) apply for export to non-Australia-Group destinations; the rule is effective on publication.