What will the orphan drug market exclusivity haircut mean for industry?

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation.

Regulatory Background: How things work now

Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.

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