Outrageous #prices of #orphan #drugs: a call for collaboration (Lancet, summary)

[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

†Contributed equally

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.


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Giuseppe Michieli

I am an Italian blogger, active since 2005 with main focus on emerging infectious diseases such as avian influenza, SARS, antibiotics resistance, and many other global Health issues. Other fields of interest are: climate change, global warming, geological and biological sciences. My activity consists mainly in collection and analysis of news, public services updates, confronting sources and making decision about what are the 'signals' of an impending crisis (an outbreak, for example). When a signal is detected, I follow traces during the entire course of an event. I started in 2005 my blog ''A TIME'S MEMORY'', now with more than 40,000 posts and 3 millions of web interactions. Subsequently I added an Italian Language blog, then discontinued because of very low traffic and interest. I contributed for seven years to a public forum (FluTrackers.com) in the midst of the Ebola epidemic in West Africa in 2014, I left the site to continue alone my data tracking job.