The Italian pharmaceutical industry wakes up today under its most concrete threat in years. Yesterday, April 2, President Donald J. Trump signed a presidential proclamation imposing tariffs of up to 100% ad valorem on all patented drugs and their related active pharmaceutical ingredients (APIs) imported into the United States, invoking Section 232 of the Trade Expansion Act of 1962 on the grounds of “national security” (see Presidential Proclamation).
The measure, outlined in a White House Fact Sheet, is not a generic threat—it is selective and highly targeted. It hits hardest those companies that have not entered into Most Favored Nation (MFN) pricing agreements with the Department of Health and Human Services (HHS) and reshoring plans for manufacturing and R&D with the Department of Commerce. By contrast, companies that have already secured such deals—26 global players to date—benefit from full exemption until January 20, 2029.
Details of the proclamation: tiered tariffs and tight timelines
According to the official White House text, the baseline tariff is set at 100% on the products listed in Annex I. Entry into force is scheduled for July 31, 2026 (120 days) for large companies and September 29, 2026 (180 days) for small and medium-sized enterprises.
However, there are calibrated exit routes:
- 0% until January 20, 2029 for companies that have already signed (or are finalizing) MFN pricing agreements and concrete onshoring commitments.
- 20% (rising progressively to 100% by April 2, 2030) for those committing only to reshoring manufacturing.
- 15% for products originating from the EU, Japan, South Korea, Switzerland, and Liechtenstein.
- Reduced or zero tariffs for the United Kingdom, depending on future pricing agreements.
Generics, biosimilars, and related ingredients are currently fully exempt (subject to review in one year). Also excluded are cell and gene therapies, orphan drugs, countermeasures for CBRN threats, veterinary products, and other categories deemed strategic for U.S. public health.
The White House justifies the measure by pointing to excessive dependence on imports: only 15% of patented APIs are produced in the United States, while 53% of patented drugs distributed on the U.S. market are sourced from abroad. “Global supply chains are vulnerable to geopolitical shocks,” the proclamation states.
The declared objective is twofold: to bring critical production back onshore and to lower drug prices for American citizens through the MFN mechanism, also accessible via the TrumpRx.gov platform.
The “protected” companies and Italy’s absence
Even before the proclamation was signed, 26 multinational companies had already secured agreements, including Pfizer, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck & Co., and Novo Nordisk. Altogether, they have pledged around $400 billion in investments in new facilities, R&D, and manufacturing in the United States. Their products already benefit from multi-year exemptions.
No major Italian company appears in the lists published on whitehouse.gov/investments or TrumpRx.gov. As a result, the national sector—strong in the production of active pharmaceutical ingredients, branded medicines, and biotechnology—remains exposed to the full tariff, unless rapid negotiation measures are undertaken.
Italy exports pharmaceuticals and vaccines to the United States for a value exceeding €11 billion annually (Farmindustria data updated to 2025, showing steady growth). The U.S. is the leading non-EU market for Italian pharma. A 100% tariff increase would render many products uncompetitive, with direct repercussions on manufacturing sites in Tuscany, Abruzzo, Lazio, Lombardy, and Campania, where both multinational companies and Italian CDMOs operate.
Farmindustria’s position: medicines are essential goods, political negotiation is key
Marcello Cattani, president of Farmindustria, has repeatedly reiterated the association’s stance in recent months: medicines are essential goods that directly affect the health of American citizens, and the response must прежде di tutto essere politica—first and foremost political.
“We are confident that negotiations by the Italian government and the European Commission can lead to a positive outcome, either excluding medicines from tariffs or significantly reducing their impact, because U.S. citizens would be the first to bear the consequences, through potential reductions in availability and higher costs.”
Cattani also stressed that the United States cannot quickly replace the approximately €11 billion worth of medicines and active ingredients sourced from Italy, and that Italy is in a strong position to conduct effective negotiations. He further called for a forward-looking approach based on “sound pragmatism,” warning against escalation that would ultimately benefit other global competitors such as China.
From Trump-era protectionism to the global supply chain
This is not a bolt from the blue. The Trump administration had already sent strong signals, with letters addressed to pharma CEOs in the summer of 2025 and the launch of a Section 232 investigation. The partial rejection of previous tariffs by the Supreme Court of the United States pushed the administration toward a more “legally robust” and targeted approach, linking tariffs to concrete reshoring and pricing commitments.
The measure reinforces an already emerging trend: many multinationals are shifting portions of their production to the United States precisely to mitigate future tariff risks. The domino effect could impact European CDMOs and Asian supply chains, potentially leading to higher costs and delays in the launch of new medicines.
For Italy—where pharmaceutical exports grew by 28.5% in 2025, driven largely by the U.S. market—the risk is twofold: loss of market share and a slowdown in foreign investment. Analysts estimate that a full impact on the €10–11 billion of exports to the U.S. could translate into a contraction of more than €2.5 billion for the national industry alone, with cascading effects on skilled employment and the broader industrial ecosystem.
Operational outlook for Italian companies
Italian pharmaceutical companies now face a set of strategic decisions to safeguard their presence in the U.S. market and mitigate the potential impact of the new proclamation.
Among the key courses of action to be assessed with urgency are:
- Detailed portfolio analysis against Annex I of the proclamation, to accurately identify which molecules and active ingredients may be subject to the 100% tariff and which fall within exempt categories (generics, biosimilars, orphan drugs, advanced therapies).
- Assessment of opportunities to initiate or accelerate negotiations for Most Favored Nation (MFN) pricing agreements with the Department of Health and Human Services (HHS) and onshoring plans with the Department of Commerce. The option combining both commitments remains the most favorable, offering tariff exemption until January 20, 2029.
- Exploration of intermediate solutions, such as partial reshoring commitments or partnerships with U.S. players, which could at least secure the reduced initial 20% tariff.
- Continuous monitoring of exemptions and potential annual revisions предусмотрte by the proclamation, particularly for categories linked to public health needs.
- Coordination with industry associations—first and foremost Farmindustria—and with Italian and European institutions, to support a joint diplomatic effort that leverages Italy’s strong position as a reliable, high-quality supplier to the U.S. market.
Many companies are already considering supply chain diversification strategies or strengthening their manufacturing presence in the United States, turning the tariff challenge into an opportunity to reassess and enhance the resilience of their global strategy.
