Industrial Policy & Trade Monitor· 2662 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.

On 13 August 2025 President Trump signed an Executive Order ("Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve", Federal Register Doc. 2025-15823, published 19 August 2025) directing the HHS Assistant Secretary for Preparedness and Response (ASPR) to refill and operationalise the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). Within 30 days, ASPR must compile an initial list of 26 essential drugs, account for available funding, and acquire and maintain a six-month supply of the corresponding APIs. Within 90 days, ASPR must deliver an expanded list of up to 86 essential medicines and medical countermeasures plus a plan to source those APIs from domestic manufacturers, and within 120 days (subject to appropriations) ready the existing SAPIR repository and submit a proposal and cost estimate for opening a second repository. The order prioritises domestically manufactured APIs in federal procurement and reserve build-out and directs interagency coordination across HHS/ASPR, FDA, DoD (Industrial Base Fund / Defense Production Act Title III), and the Department of Commerce.

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.

The US Bureau of Industry and Security issued a final rule on 5 September 2024 (effective 6 September 2024, published in the Federal Register on the same day as 89 FR 73285) establishing multilateral export controls on four categories of emerging technologies: (1) quantum computing items including quantum computers, related cryogenic / control / measurement systems, and certain quantum software; (2) gate-all-around field-effect transistor (GAAFET) production technology — the next-node semiconductor architecture beyond FinFET; (3) advanced additive-manufacturing equipment for metals + alloys; (4) certain biotech-related items added in a parallel rule on 12 September 2024. The rule operates without country exceptions for some categories, with multilateral coordination via Wassenaar + Australia Group + Nuclear Suppliers Group frameworks.