On April 2, 2026, U.S. President Donald J. Trump issued a proclamation determining the imposition of measures under Section 232 of the Trade Expansion Act of 1962 regarding imports of patented pharmaceutical products and their associated pharmaceutical ingredients, including active pharmaceutical ingredients and key starting materials. The measure is based on the conclusion that such imports are being made in quantities and under circumstances that threaten to harm the national security of the United States.
Among the most significant aspects of this measure are the following:
- A general tariff of 100% on patented pharmaceutical products.
A general 100% ad valorem tariff is established for imports of patented pharmaceutical products and associated pharmaceutical ingredients identified in Annex I, such as naproxen, iodoquinol, and piperazine salts, to name a few products in their commercial form.
- Reduced rate for companies with production relocation plans.
A 20% ad valorem rate is provided for products from companies with relocation plans approved by the U.S. authority; however, this rate will increase to 100% as of April 2, 2030.
- Preferential treatment for certain jurisdictions.
A 15% tariff rate is established for products from Japan, the European Union, the Republic of Korea, Switzerland, and Liechtenstein, while a 10% rate is set for the United Kingdom, with the possibility of a reduction to 0% if provided for in a future bilateral agreement.
A 0% rate is provided for certain specialized medicines, including orphan drugs (intended to treat rare diseases), nuclear medicines, plasma-derived therapies, fertility treatments, cell and gene therapies, antibody-drug conjugates, medical countermeasures against chemical, biological, radiological, and nuclear threats, other specialized products determined by the authority, and animal health products, subject to compliance with specific conditions.
- Benefit for companies with Most-Favored-Nation pricing agreements and relocation commitments.
Companies with eligible relocation plans and pharmaceutical pricing agreements under Most-Favored-Nation criteria will be eligible for a 0% tariff rate through January 20, 2029.
- Exclusion of generic and biosimilar drugs.
The proclamation stipulates that, for now, generic drugs, biosimilars, and their associated ingredients will not be subject to these tariffs.
- Tariff Preferences Under Trade Agreements
Tariff preferences arising from free trade agreements signed by the United States are not expected to apply; therefore, the applicable tariff treatment must be determined in accordance with the rates, conditions, and exceptions expressly provided for in the proclamation itself.
The measures will apply starting July 31, 2026, for companies listed in Annex III, such as AstraZeneca Pharmaceuticals, Johnson & Johnson, and Pfizer Inc., to name a few, and starting September 29, 2026, for all other companies.
- Monitoring of relocation commitments.
The U.S. authority will establish criteria for approving, monitoring, and enforcing compliance with relocation plans, and may even reimpose tariffs prospectively and retroactively in cases of non-compliance, fraud, or misleading information.
- Availability of duty drawback.
The proclamation expressly provides for the availability of duty drawback with respect to duties applicable under this proclamation.
- Enhanced customs oversight and enforcement powers
The proclamation grants additional powers to U.S. Customs and Border Protection (CBP) for the administration and enforcement of these measures.
The goods covered by this proclamation are listed at the following link: ANNEXES I, II, III, and IV
J.A. DEL RÍO offers a wide array of specialized consulting services to assist you with these and other matters, in order to ensure that your project complies with the applicable characteristics contained in this agreement.
If you have any questions, J.A. DEL RÍO can provide you with our experts to advise in matters concerning compliance with your legal and tax obligations. Once again, please let us know if we may be of any further assistance to you at: contacto@jadelrio.com.
