Tariff Waivers Unlock Rare Disease Drugs and Gene Therapies
Published Date: 9/23/2026
Notice
Summary
Starting September 23, 2026, certain specialty medicines and their ingredients can enter the U.S. without extra tariffs if they come from approved countries or meet urgent health needs. This includes rare disease drugs, gene therapies, and medical countermeasures. The Department of Commerce also fixed some technical errors in the tariff rules and set up a way for the public to ask for urgent health need approvals.
Analyzed Economic Effects
6 provisions identified: 6 benefits, 0 costs, 0 mixed.
Zero tariffs for certain specialty medicines
If you import or rely on certain specialty medicines, those products can qualify for a zero ad valorem tariff under Proclamation 11020 if they are in the listed categories and come from an eligible jurisdiction or meet an urgent U.S. health need. The eligible product categories named include orphan drugs, nuclear medicines, plasma-derived therapies, fertility drugs, cell therapies, gene therapies, antibody–drug conjugates, medical countermeasures for CBRN threats, and animal health products. The HTSUS changes applying these tariff adjustments take effect for goods entered on or after 12:01 a.m. eastern time on September 29, 2026.
Which countries qualify for zero tariffs
Products described in the rule are eligible for the zero tariff if they are products of one of the listed jurisdictions: Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, European Union, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, Republic of Korea, Switzerland and Liechtenstein, Taiwan, Thailand, United Kingdom, and Vietnam. The notice says changes to this list may be published in a future notice.
How to request urgent-health-need tariff approval
Companies can request Commerce approval for a zero tariff on a single patented specialty product if the import meets an urgent U.S. health need by emailing BIS at [email protected]; submissions are accepted on an ongoing basis starting September 23, 2026. Each application must include organization info, one product per application (HTSUS classification if possible), product category (e.g., orphan, gene therapy, CBRN countermeasure), country of origin/export, importer of record, manufacturer, and a rationale explaining the urgent U.S. health need. Commerce will consult with USTR and HHS, make company- and product-specific decisions, and notify companies in writing; CBP will apply any approved adjustment at entry summary filing.
Zero duty for clinical-trial and R&D imports
A new HTSUS heading 9903.04.70 provides an ad valorem tariff rate of zero for pharmaceutical products and associated ingredients that are solely for clinical trials, research and development, or other non-commercial uses. This change is effective for goods entered on or after 12:01 a.m. eastern time on September 29, 2026.
Generic definition now includes unpatented animal products
The rule amends the definition of 'generic pharmaceutical articles' (subdivision (c)(iii) for heading 9903.04.67) to specifically include 'unpatented animal health products.' Earlier in the notice the agency states Section 232 pharmaceutical tariffs do not apply to generic pharmaceutical products, so this definitional change affects how unpatented animal health products are classified under the tariff rules.
Confidentiality protections for submissions
Commerce will protect confidential, trade secret, and proprietary information submitted in requests for urgent-health-need approvals to the fullest extent allowed by law, citing the Trade Secrets Act (18 U.S.C. 1905) and FOIA Exemptions 3 and/or 4. Commerce will limit dissemination of confidential information to those within Commerce, USTR, and necessary executive branch agencies who need to know to evaluate the request.
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Key Dates
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