1. Orphan medicines

1.2. Incentives

Orphan designation offers incentives to encourage development of orphan medicines and their availability. Incentives for sponsors include

Of note: Some 60% of designated orphan medicines are intended for paediatric use since many childhood diseases are rare. Medicines authorised across the EU with the results of studies from a paediatric investigation plan included in the product information are eligible for an extension of their supplementary protection certificate. For designated orphan medicines, the incentive is an additional two years of market exclusivity.

Legal Basis:

Regulation (EC) No 141/2000
Commission notice on the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products setting out its interpretation on certain matters relating to the implementation of the designation and the market exclusivity provisions.
For a detailed inventory of the underlying legal basis see: EMA - Legal framework: orphan designation