AD Article
Pharma Package – Deal at the EU level on a major pharma reform
The European Parliament and the Council of the EU have reached a provisional agreement on the Pharma Package, the most significant overhaul of EU pharmaceutical law in the past twenty years. The reform introduces a new directive and regulation that update regulatory data protection rules, expand the Bolar exemption, strengthen obligations on medicine supply and market continuity, and create a new transferable exclusivity voucher to incentivize priority antibiotic development. The agreement now awaits formal adoption before entering into force.