On April 2, 2026, the Trump Administration issued a proclamation imposing Section 232 tariffs on imports of patented pharmaceutical products and active pharmaceutical ingredients (“APIs”) pursuant to Section 232 of the Trade Expansion Act of 1962 (“Section 232”).
Section 232 authorizes the President to adjust imports of articles that are imported in quantities or under circumstances that threaten to impair the national security of the United States. Citing national security concerns stemming from the United States’ substantial reliance on foreign pharmaceutical manufacturing—approximately 53% of patented pharmaceutical products and 85% of patented APIs (by volume) are produced abroad—the Administration stated that the tariffs are intended to incentivize greater domestic production.
Below are key highlights of the proclamation that pharmaceutical manufacturers and importers should be aware of:
- The Baseline Tariff: The proclamation imposes a 100% ad valorem duty rate on imported patented pharmaceuticals and their associated APIs.
- Effective Date for Large Companies: For certain large companies designated in Annex III to the proclamation, the tariffs will take effect 120 days after issuance, on July 31, 2026.
- Effective Date for Smaller Companies: For smaller companies and all other importers, the tariffs will go into effect 180 days after issuance, on September 29, 2026.
The proclamation does not apply the tariffs uniformly across all products; instead, it includes several important exemptions and reduced rates as discussed below:
- Pharmaceuticals Listed in Annex IV: The proclamation establishes a specific list of pharmaceutical products and ingredients that are subject to a zero-tariff rate at this time, which are formally detailed in Annex IV to the proclamation. Annex IV may be updated from time to time, and the scope of the products eligible for the zero-tariff rate may change accordingly. Annex also IV indicates that these products are exempt from the Section 122 (balance of payments) tariffs imposed by Proclamation 11012 of February 20, 2026.
- Generics and Biosimilars: Generic pharmaceuticals, biosimilar products, and their associated ingredients are entirely exempt from these tariffs at this time, though the Secretary of Commerce will reassess this exemption in one year.
- U.S. Origin Products: Imports of U.S.-origin pharmaceutical products are not subject to the new tariffs.
- Specialty Pharmaceutical Products: A 0% tariff rate applies to specific categories, including orphan drugs, nuclear medicines, cell and gene therapies, fertility treatments, plasma-derived therapies, antibody drug conjugates, medical countermeasures, and drugs for animal health. To qualify, these must come from a jurisdiction with a recognized trade deal or meet an urgent public health need.
- Trade Deal Countries: Imports from the European Union, Japan, the Republic of Korea, Switzerland, and Liechtenstein are subject to a reduced 15% tariff rate. Additionally, imports from the United Kingdom face a 10% tariff rate, which is expected to drop to zero pending a future bilateral agreement between the United States and the United Kingdom.
- Onshoring and Pricing Agreements: Companies with approved onshoring agreements with the Department of Commerce will pay a reduced 20% duty rate, though the proclamation states that this rate will jump to 100% in four years, on April 2, 2030.
For companies that execute both onshoring agreements and Most Favored Nation (“MFN”) pricing agreements with the Department of Health and Human Services (“HHS”), a 0% tariff rate will apply through January 20, 2029.
The Department of Commerce and HHS will provide pathways for companies to enter into onshoring and MFN pricing deals with the U.S. Government.
Annex Summaries:
- Annex I: Identifies the patented pharmaceutical products and associated pharmaceutical ingredients that are subject to the new Section 232 tariffs. Products listed in Annex I are generally subject to the baseline 100% ad valorem duty, subject to the exemptions and reduced tariff rates described above.
- Annex II: Identifies a specific list of company-specific tariff agreements that the Secretary of Commerce entered into prior to the proclamation’s issuance. The specific companies listed are granted a zero-tariff rate on their imported patented pharmaceuticals and associated pharmaceutical ingredients.
- Annex III: This list identifies certain large companies subject to the tariffs that are set to go into effect on July 31, 2026 (120 days after the issuance of the proclamation). For all other companies not included in this Annex, the tariffs will go into effect on September 29, 2026 (after 180 days).
- Annex IV: Pharmaceutical products and ingredients that are currently subject to a zero-tariff rate under the current Section 232 action.
In connection with the proclamation, the White House released a fact sheet outlining the applicable Section 232 tariff rates, covered products, and related implementation details.
Husch Blackwell’s International Trade and Supply Chain team will continue to monitor and provide updates as they become available. For specific questions, please contact your Husch Blackwell attorney.