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Challenges to orphan drugs access in Eastern Europe: The case of Bulgaria

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  • Iskrov, Georgi
  • Miteva-Katrandzhieva, Tsonka
  • Stefanov, Rumen

Abstract

This article explores how an Eastern European country could deal with orphan drugs access, combining EU policies with its own national settings. The cross-sectional observational study takes the total number of orphan drugs (61) available on EU level by March 2011, and then consecutively filters it through the requirements and criteria of relevant Bulgarian legislation on registration, pricing and reimbursement of medicinal products, obtaining the final number of accessible orphan drugs (16) in Bulgaria. The study further evaluates the average time period from market authorisation to positive reimbursement decision by Bulgarian health authorities (43±29.1months).

Suggested Citation

  • Iskrov, Georgi & Miteva-Katrandzhieva, Tsonka & Stefanov, Rumen, 2012. "Challenges to orphan drugs access in Eastern Europe: The case of Bulgaria," Health Policy, Elsevier, vol. 108(1), pages 10-18.
  • Handle: RePEc:eee:hepoli:v:108:y:2012:i:1:p:10-18
    DOI: 10.1016/j.healthpol.2012.08.013
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    References listed on IDEAS

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    6. Denis, Alain & Mergaert, Lut & Fostier, Christel & Cleemput, Irina & Simoens, Steven, 2010. "A comparative study of European rare disease and orphan drug markets," Health Policy, Elsevier, vol. 97(2-3), pages 173-179, October.
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    1. repec:eee:hepoli:v:121:y:2017:i:12:p:1240-1248 is not listed on IDEAS

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