Table 1 Key incentives of the orphan legislation in the EU and US
Incentives | In EU | In US |
|---|---|---|
Marketing exclusivity | 10 years + 2 if paediatric | 7 years |
Clinical development costs | – | tax credits (up 50% of clinical development costs) |
Orphan designation | free of charge | free of charge |
Support from agency during the development process | free of charge protocol assistance | free of charge OOPD (Office of orphan Products Development) assistance |
MAA | 40% fee reduction; free of charge for SMEs and for paediatric products | fee reduction |
Fee reductions for SMEs | 90% of fee reduction for post authorisation inspections; free of charge pre-authorisation inspections, post-authorisation activities, including annual fees, during the first year after marketing authorisation | – |
Public funds | (possible) incentives from EC (i.e. research grants) | grants and contract for development of orphan drugs |
(possible) incentives in single Member States for research, development and MA | Â |