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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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    1. Degtiar, Irina, 2017. "A review of international coverage and pricing strategies for personalized medicine and orphan drugs," Health Policy, Elsevier, vol. 121(12), pages 1240-1248.
    2. Zoltán Kaló & Adrian Gheorghe & Mirjana Huic & Marcell Csanádi & Finn Boerlum Kristensen, 2016. "HTA Implementation Roadmap in Central and Eastern European Countries," Health Economics, John Wiley & Sons, Ltd., vol. 25(S1), pages 179-192, February.
    3. Vogler, Sabine & Fischer, Stefan, 2020. "How to address medicines shortages: Findings from a cross-sectional study of 24 countries," Health Policy, Elsevier, vol. 124(12), pages 1287-1296.
    4. Belousova, Olga A. & Groen, Aard J. & Ouendag, Aniek M., 2020. "Opportunities and barriers for innovation and entrepreneurship in orphan drug development," Technological Forecasting and Social Change, Elsevier, vol. 161(C).
    5. Pejcic, Ana V. & Iskrov, Georgi & Jakovljevic, Mihajlo Michael & Stefanov, Rumen, 2018. "Access to orphan drugs – comparison across Balkan countries," Health Policy, Elsevier, vol. 122(6), pages 583-589.
    6. Todd Gammie & Christine Y Lu & Zaheer Ud-Din Babar, 2015. "Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries," PLOS ONE, Public Library of Science, vol. 10(10), pages 1-24, October.
    7. Constanza Vargas & Richard Abreu Lourenco & Manuel Espinoza & Stephen Goodall, 2025. "Systematic Literature Review of Access Pathways to Drugs for Patients with Rare Diseases," Applied Health Economics and Health Policy, Springer, vol. 23(2), pages 209-229, March.

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