Firms May Lose Data Exclusivity Earlier Under Planned EU Adaptive Licensing Regime

Adaptive licensing for breakthrough pharmaceutical products in the EU is generally considered by the innovative pharmaceutical industry to be a vital tool to make the drug development system sustainable in the long term. But this type of conditional approval − which would allow a drug to be offered to certain patients on a limited data package and before a full license has been granted – could carry a sting for drug manufacturers, due to a potentially earlier loss of data exclusivity.

Under current plans, the data exclusivity clock would start once initial, conditional approval was granted. This worries some sector players,...