Table 1. Key incentives of the orphan drug legislation in Europe and the US^*.

Items	EU	US
Market exclusivity	10 yearsa,b	7 yearsd
Protocol assistance and follow-up	Yes	Yes
Reduced / waived regulatory fees	Yes	Yes
Tax credit on clinical trials	No	Yes
Specific subsidies for clinical trials	Noc	Yes

^aplus an extra 2 years if paediatric development included;

^bmay be reduced to 6 years if the product is sufficiently profitable;

^cEU funding is available for rare diseases in addition to various national grants;

^dplus an additional 6 months of paediatric exclusivity for qualified studies.

^*Adapted from reference (3) and (4).