J Appl Biomed 16:175-179, 2018 | DOI: 10.1016/j.jab.2018.04.002

Legislation, regulation and policies issues of orphan drugs in developed countries from 2010 to 2016

Petra Maresova, Blanka Klimova, Kamil Kuca*
University of Hradec Kralove, Faculty of Informatics and Management, Hradec Kralove, Czech Republic

The purpose of this study is to evaluate current legislative policies and regulations with respect to the use of orphan drugs, to emphasize strengths and weaknesses of these policies in the period of 2010-2016 in European countries, especially in relation to the objectives set by the European Council in 2009. This was done by the method of literature search in the databases PubMed, Scopus, ScienceDirect, and Web of Science from 2010 to 2016. The findings show a lack of polices for the appraisal and reimbursement of orphan drugs, a lack of uniform European legislation and different orphan drugs expenditure.

Keywords: Legislation; Policy issues; Rare diseases; Orphan drugs; Europe

Received: October 8, 2017; Revised: December 9, 2017; Accepted: April 26, 2018; Published: August 1, 2018  Show citation

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Maresova P, Klimova B, Kuca K. Legislation, regulation and policies issues of orphan drugs in developed countries from 2010 to 2016. J Appl Biomed. 2018;16(3):175-179. doi: 10.1016/j.jab.2018.04.002.
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