Pharma Pulse: EU's Pharma Package and Specialty Drug Tariff Exemptions

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast bringing you the latest insights shaping patient access, regulatory policy, and healthcare innovation. I'm your host, and let's get into today's headlines.

First up, the EU's pharmaceutical overhaul has cleared a major hurdle. The Council of the European Union formally adopted the pharma package, a regulation and directive aimed at improving access to affordable medicines, easing regulatory burden and strengthening security of supply.¹ Innovators receive eight years of data protection plus one year of market protection, extendable to a maximum of 11 years for medicines that meet innovation criteria or address an unmet medical need. Orphan drugs get nine years of market exclusivity, rising to 11 for "breakthrough" orphan medicines. A new transferable exclusivity voucher rewards antibiotic development. Member states can also require companies to supply protected medicines in quantities that meet patient needs. The European Parliament must still adopt both texts before they take effect.

Next, the Department of Commerce has spelled out which specialty drugs can avoid the new pharmaceutical tariffs. Guidance from the Bureau of Industry and Security, published last week, sets procedures for a 0% rate on specialty products otherwise subject to the 100% Section 232 tariff on patented drugs. That tariff reached the rest of the industry on Sept. 29.² Qualifying categories include drugs whose approved indications are all orphan-designated, nuclear medicines, plasma-derived therapies, fertility drugs, cell and gene therapies, antibody-drug conjugates, medical countermeasures and animal health products.

To qualify, products must come from a jurisdiction with a trade and security framework agreement. The notice lists these, including the EU, Japan, India, South Korea, Switzerland and the UK. Otherwise, they must meet what Commerce deems an urgent U.S. health need. Generics remain outside the tariffs for now, and a new 0% heading covers pharmaceutical articles imported solely for clinical trials and research and development.²

Lastly, Sharp Services is adding autoinjector and pen assembly capacity in the U.S. and Europe as injectable demand grows. Building on a previously announced $20 million investment, the CDMO expects a low-speed line assembling two devices per minute at its Macungie, Pa., site by the first quarter of 2027. A mid-speed line running 50 autoinjectors per minute will follow in the first quarter of 2028.³ Macungie has also added more than 4,400 pallet locations of temperature-controlled storage. In Bethlehem, Pa., a dedicated low-speed line will serve clinical and low-volume commercial programs, particularly rare disease and orphan drugs. In Belgium, Sharp is adding assembly equipment running up to 100 devices per minute and a fully automatic 2°C-8°C warehouse.

That's it for this episode of Pharma Pulse. For more insights on trends transforming pharmaceutical access, visit pharmaceuticalcommerce.com. Thanks for listening, until next time, stay well and stay informed.

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References

1. Council of the European Union. "Pharma package: Council adopts new rules for a fairer and more competitive EU pharmaceutical sector." September 28, 2026. https://www.consilium.europa.eu/en/press/press-releases/2026/09/28/pharma-package-council-adopts-new-rules-for-a-fairer-and-more-competitive-eu-pharmaceutical-sector/
2. Bureau of Industry and Security, U.S. Department of Commerce. "Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals and Associated Pharmaceutical Ingredients." Federal Register. September 23, 2026. https://www.federalregister.gov/documents/2026/09/23/2026-19498/guidance-and-procedures-for-implementing-tariff-adjustments-for-specialty-pharmaceuticals-and
3. Sharp Services. "Sharp Expands Autoinjector and Pen Assembly Capacity in US and EU to Support Growing Injectable Demand." September 22, 2026. https://www.sharpservices.com/about-us/news/sharp-expands-autoinjector-and-pen-assembly-capacity-in-us-and-eu-to-support-growing-injectable-demand/