[Source: The Lancet, full page: (LINK). Abstract, edited.]
Outrageous prices of orphan drugs: a call for collaboration
Prof Lucio Luzzatto, MD†, Hanna I Hyry, MA†, Arrigo Schieppati, MD, Enrico Costa, Pharm D, Prof Steven Simoens, PhD, Prof Franz Schaefer, Jonathan C P Roos, PhD, Prof Giampaolo Merlini, MD, Prof Helena Kääriäinen, MD, Prof Silvio Garattini, MD, Prof Carla E Hollak, MD, Prof Giuseppe Remuzzi, MD on behalf of the Second Workshop on Orphan Drugs participants
Published: 20 July 2018 / DOI: https://doi.org/10.1016/S0140-6736(18)31069-9
© 2018 Elsevier Ltd. All rights reserved.
Few instances of a single act of legislation have shifted industrial policy in the pharmaceutical industry like the Orphan Drugs Act did when it was signed in the USA in 1983. The Act was written to facilitate the development of drugs for rare diseases and health conditions,1 and the incentives provided by the Act, such as 7 year exclusivity, tax credits of up to 50% of research and development costs, and access to research and development grants, resulted in the US Food and Drug Administration2 (FDA) approving 575 drugs and biological products for rare diseases between 1983 and 2017—a real success.
Keywords: Society; Public Health.