The EU Pharma Package: the Future of Bolar Clause and Regulatory Exclusivity

Sterne Kessler’s Paul Calvo, Ph.D. was a speaker on the “The EU Pharma Package: The Future of Bolar Clause and Regulatory Exclusivity” webinar hosted by SIB.

The proposed EU Pharmaceutical Package is set to reshape key mechanisms governing pharmaceutical innovation and competition, including the Bolar exception and regulatory exclusivities. These changes may significantly affect the entry of generic and biosimilar medicines and market access strategies.

During the session, Paul provided a U.S. comparative perspective, highlighting key differences and strategic considerations for stakeholders operating across jurisdictions. The session also offered a concise overview of how evolving EU rules may influence innovation, patent strategy, and competition, and was aimed at legal, regulatory, R&D, and industry professionals in the life sciences sector.