Navigating Trump’s New Pharmaceutical Tariffs

New tariffs introduced by Donald Trump in April 2026 create significant legal and compliance challenges for pharmaceutical companies. The policy imposes tariffs of up to 100% on patented drugs and related ingredients under Section 232 of the Trade Expansion Act but includes multiple exceptions that complicate how the rules apply in practice. 

Legally, the scope is limited to products protected by valid U.S. patents and listed with the U.S. Food and Drug Administration. This excludes many off-patent drugs and over-the-counter products. Generics and biosimilars are also currently exempt, although this could change following a government review. 

Tariff exposure depends on several factors, including patent status, country of origin and whether a company qualifies for exemptions. Lower rates may apply to imports from countries with trade agreements, while companies that commit to U.S. manufacturing or agree to most-favored-nation pricing can access reduced or zero tariffs, subject to ongoing obligations. 

Certain categories, such as orphan drugs and advanced therapies, may qualify for conditional exemptions, but these require regulatory approval and are not automatic. This adds further uncertainty for importers. 

From a compliance perspective, companies must carefully assess tariff classifications, product origin and intended use. Enforcement by U.S. Customs and Border Protection is expected to increase, and unclear provisions mean further guidance from agencies like the U.S. Department of Commerce is likely. 

Overall, companies should prioritise compliance reviews and prepare for evolving regulatory interpretation as the policy is implemented.