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.

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.

Ireland's Screening of Third Country Transactions Act 2023 (Act No. 28 of 2023), signed into law on 31 October 2023 and commenced on 6 January 2025 via S.I. No. 651 of 2024, establishes Ireland's first-ever mandatory inbound FDI screening regime. The Act empowers the Minister for Enterprise, Tourism and Employment to assess, condition, or prohibit transactions by third-country investors (non-EU/EEA/Switzerland) exceeding a EUR 2 million cumulative threshold in targets operating across critical infrastructure, critical technologies, dual-use items, supply of critical inputs, sensitive personal data, and media freedom. A 90-day standstill period applies during Ministerial determination, with criminal sanctions and transaction-voiding powers available for non-compliance.