{"id":264,"date":"2026-07-18T06:10:56","date_gmt":"2026-07-18T04:10:56","guid":{"rendered":"https:\/\/www.pqra.gr\/the-eu-pharma-package-a-new-baseline-for-exclusivity-and-access\/"},"modified":"2026-07-18T06:11:22","modified_gmt":"2026-07-18T04:11:22","slug":"the-eu-pharma-package-a-new-baseline-for-exclusivity-and-access","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/the-eu-pharma-package-a-new-baseline-for-exclusivity-and-access\/","title":{"rendered":"The EU Pharma Package: A New Baseline for Exclusivity and Access"},"content":{"rendered":"

After more than two years of negotiation, the European Union has settled the text of its new pharmaceutical legislation — the most significant overhaul of the medicines framework in over two decades. Political agreement between the Council and the European Parliament was reached on 11 December 2025, and the package is now moving through its final procedural steps towards publication in the Official Journal. For companies planning EU launches, the reform reshapes the exclusivity, orphan and access rules that underpin every product strategy.<\/strong><\/p>\n\n

Where the reform stands<\/h2>\n

The revised legislation — a new Regulation and a new Directive replacing the current framework — completed trilogue negotiations in December 2025. Member State representatives (Coreper) endorsed the compromise text on 6 March 2026, and the Parliament’s health committee approved it on 18 March 2026. The texts are undergoing legal-linguistic revision before formal adoption, expected in the second half of 2026, followed by a transition period of roughly two years. Sponsors should treat the settled provisions as their planning baseline now, rather than waiting for the Official Journal.<\/p>\n\n

A new baseline for regulatory data protection<\/h2>\n

The headline change concerns regulatory data protection (RDP). The standard period moves from the current eight years of data exclusivity plus two years of market protection (8+2) to a baseline of eight plus one (8+1). Companies can, however, build protection back up — to a capped maximum of eleven years — by meeting defined conditions. Additional periods can be earned for factors such as:<\/p>\n