The EU orphan framework is public. What breaks it isn’t.
Every incentive is documented. Yet, biotechs can still miss out on the value because they managed incentives, timelines and market access as three separate workstreams instead of one integrated strategy.
This White Paper uncovers:
Why the December 2025 pharma reform changes more than just exclusivity duration, and what it means for programs already in development.
The designation window that closes the moment your MAA is submitted, even if still pending.
Why being “too profitable” at year 5 can legally reduce your exclusivity from 10 to 6 years.
The 90-day COMP clock that cannot be stopped, even with new data.
Why your JCA evidence is locked before EMA has finished reviewing your file.
How a misaligned HTA narrative can force separate brand names for the same molecule.
The sequencing logic that determines how much theoretical incentive value you actually capture.
