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Revision of the Orphan Regulation: Estimated impact on incentives for innovation of changes proposed by the European Commission

Emilie Neez, Adam Hutchings
September 2023

Despite the tremendous therapeutic advances delivered in rare diseases since the adoption of the Orphan Regulation in 2000, the European Commission has proposed a set of legislative revisions aimed at bolstering innovation whilst enhancing access and affordability. This study, based on a risk-adjusted Net Present Value framework, evaluates the expected impact on innovation in Europe of revisions within the next 15 years.


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