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Has the Orphan Regulation Met its Aims?

A Critical Examination of the European Union’s Regime Incentivising Research and Development of Medicines for Patients with Rare Diseases


Laëtitia Bénard, Jacqueline Bore, Eveline Van Keymeulen

By the 1990’s the European Union had fallen behind other developed economies in the encouragement and support its pharmaceutical regulatory framework offered to the development of new treatments for rare diseases. The aim of the Orphan Regulation was to remedy this. We examine critically the interplay of the legal instruments underpinning the scheme of orphan incentives with the judgments of the Court of Justice and conclude that the definitions and tests embodied by the Orphan Regulation, which decide which products should be rewarded, have served patients with rare diseases well.

Laëtitia Bénard is a Partner at Allen & Overy LLP. She leads the Paris Intellectual Property practice and is co-head of the firm’s Life Sciences group. For correspondence <>. Eveline Van Keymeulen is a Counsel at Allen & Overy LLP and heads the firm’s Regulatory Life Sciences practice. For correspondence <>. Jacqueline Bore is a Senior Professional Support Lawyer at Allen & Overy LLP. For correspondence <>.


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