European Union approves regulations updating drug market protections across all member states. New rules aim to ensure safe, effective, and affordable medications for patients everywhere.
Clinical data from drug developers will be protected for eight years, restricting competitors’ use.
Generic and biosimilar rivals face one year market exclusivity disadvantage against new medicines. For innovative drugs or special cases, market protection extensions of one year are possible.
Certain antibiotics and orphan drugs benefit from up to twelve years of exclusivity protection. Following European Parliament approval, changes will be published in the Official Journal.