Orphan drugs: ten years of experience with the EU framework on stimulating innovation for treating rare diseases
by Andreas Zaby
International Journal of Technology, Policy and Management (IJTPM), Vol. 11, No. 3/4, 2011

Abstract: This paper reviews the European Union's (EU's) legislative framework on orphan medicinal products in terms of the deliberations prior to its enactment as well as the key criteria, institutions and procedures established by it. This paper further examines the economic incentives, particularly the market exclusivity incentive, created for stimulating innovation by pharmaceutical companies for treating rare diseases. A quantitative analysis of the impact this innovation policy has had to date is provided by analysing the development of the number of active orphan drug designations and corresponding marketing authorisations during the ten-year period since the enactment of this legislation. The EU framework is compared to the US Orphan Drug Act and critical perspectives, such as pricing, patient access and off-label use, are discussed.

Online publication date: Tue, 31-Mar-2015

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