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.

On 1 May 2026 the trade pillar of the EU-Mercosur Partnership Agreement (the "Interim Trade Agreement", iTA) entered provisional application between the European Union and the four Mercosur states — Argentina, Brazil, Paraguay and Uruguay — following its publication in the EU Official Journal on 27 February 2026 alongside the broader EU-Mercosur Partnership Agreement (EMPA). The iTA covers goods (eliminating duties on more than 90% of bilateral trade over a transition period including immediate cuts on cars, pharmaceuticals, wine and olive oil), services, government procurement at federal and state level, intellectual property (344 EU geographical indications protected), SPS/TBT disciplines, and a sustainability chapter. Mercosur receives tariff-rate quotas on agri-food exports (beef, poultry, sugar, ethanol, honey). Provisional application proceeds pending full ratification of EMPA by the Council, European Parliament and all EU national parliaments and a pending CJEU opinion; only the trade pillar applies provisionally.

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.

China's State Council promulgated Order No. 818 on 28 September 2025 (effective 1 May 2026), establishing a comprehensive dual-track regulatory framework for biomedical new technologies — defined as techniques operating at the cellular or molecular level not yet clinically applied in China, covering cell therapy, gene editing, CAR-T, stem-cell, xenotransplantation, brain-computer interfaces, and nucleic-acid therapies. The regulation creates two parallel pathways: a traditional NMPA drug/device registration route and a new NHC-supervised clinical-research-to-commercialization track applicable to highly personalised or rare-disease therapies meeting staged safety and efficacy thresholds. Commercialisation under the NHC track is initially restricted to accredited Grade-3A medical institutions without full NMPA marketing approval, potentially accelerating patient access for qualifying technologies by 5–8 years relative to the standard registration pathway.

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.