Article
The EU Pharma Package Is Finally Here – Here's The Settled Position On Key Areas
The EU Pharma Package introduces the most comprehensive reform of European pharmaceutical legislation in over two decades, fundamentally restructuring regulatory data protection, market exclusivity periods, and orphan drug incentives. With political agreement reached and formal adoption imminent, pharmaceutical companies face significant changes to data protection frameworks, supply obligations, and the expanded Bolar exemption that will reshape competitive dynamics across the European medicines market.
Herbert Smith Freehills Kramer LLP